Agfa signs letter of intent to buy stake in Quadrat

Agfa-Gevaert Group (Mortsel, Belgium) has signed a letter of intent to purchase an equity stake in European software manufacturer Quadrat N.V. (Deurle, Belgium).

Luc Wanten, general manager of Agfa Impax Solutions Europe, said Agfa is negotiating the exact equity position Agfa will take in Quadrat as part of the due diligence process. He would not disclose any additional financial details, saying only that negotiations are continuing. The deal is expected to close by the end of this month.

Quadrat develops software applications for the healthcare market, including Qdoc, a RIS package tailored to what Wanten called the medium- to high-end segment of the European market; Qplanner, a hospital-wide resource planning software package; and medAr, an electronic patient record.

“Starting from the work list, [a radiologist] can immediately go into the RIS, look at previous reports, then immediately swap over to images and start reporting even by using voice recognition,” said Wanten. “That makes life easier, much more efficient.”

Agfa’s investment in Quadrat initially will benefit the two companies’ European customers, Wanten said, adding that it is “premature” to consider the impact on Agfa’s U.S. operations.

“Because Quadrat is based in Belgium, we will start building up from there,” he added. “Primarily, we are looking at the European market.”

Agfa manages more than 400 PACS worldwide, including installations in the Nordic region, Germany, France, Belgium, Netherlands and the United Kingdom.

“I would not compare the RIS market in Europe with the RIS market in the United States, because the United States has much more consolidation than Europe,” Wanten said. “You have some big players, which we don’t see in Europe; we have more fragmentation. Also, in Europe we have multilingual requirements. Quadrat offers products that can function well in the Benelux market, the French market, the Italian market and also the Nordic market. That gives us quite a competitive advantage to rolling out those systems in Europe.”

Agfa’s pairing with Quadrat is not new, Wanten said. The firms have a short history of working together on a limited, country-to-country basis, offering a hybrid Impax-Quadrat arrangement to some European customers.

“One of the first [ventures] we did was in Holland, where we installed both Impax and Quadrat, and it seemed that it worked fine,” he said. “Customers were satisfied, so we said that was a nice start. Why shouldn’t we continue our discussions and perhaps go a step further?”

Quadrat employs about 55 people at its headquarters in Duerle and reported estimated sales of $4.5 million in 1999.

DBA Systems gains FDA clearance on ImagClear

d01a.jpg (10228 bytes)The news on the digital mammography front took a turn for the positive when DBA Systems Inc. (Melbourne, Fla.) on Feb. 10 received FDA 510(k) clearance on its ImagClear mammography review system.

The clearance came only days after GE Medical Systems (Waukesha, Wis.) become the first company to gain clearance for a full-field digital mammography system with its Senographe 2000D.

While GEMS’ approval covers only hardcopy use, the DBA clearance gives the first green light for softcopy review of digital mammograms.

The ImagClear system scans and digitizes mammography films for review on DBA’s Capture and View workstation. Glenn Turner, manager of medical imaging product research and development at DBA, said ImagClear uses an FDA-cleared, mammography-specific film digitzer that produces images of 42 microns per pixel resolution and 16 bits of greyscale. Turner said the digitizer has been cleared for two years and has been waiting for the workstation’s completion.

ImagClear is available in three configurations, ranging in price from $100,000 to $180,000. The combined system, called the Capture and View Workstation, includes the digitizer and processing workstation, as well as a CD writer for storage requirements and DICOM compatibility.

“If you’re in a busy working environment with only one system, you may have the radiologist who wants to view and the technologist scanning and preparing the images on the same system,” said Turner. “We can break the system up into a separate capture and separate viewing stations.”

While it is configured to work with any hardcopy mammography system, DBA knows the future of mammography is digital.

“It’s a bridge product,” Turner said. “It’s DICOM-compliant, so it will play with digital modalities.”

He added that DBA intends to eventually merge ImagClear with a computer-aided detection (CAD) system, but feels that CAD technology has some improvements to make.

“We think there is a major deficiency in CAD in that it flags too many false positives,” Turner said.

The ImagClear currently is distributed exclusively in the Southeastern United States. Turner said DBA hopes to finalize additional distribution agreements in other parts of the country in the coming months.

Medical giants team up for Web-based purchasing

Five of healthcare’s heavy hitters have unveiled a plan to establish a new Internet-based company to streamline the purchasing of supplies and equipment of hospitals and healthcare providers.

The Global Healthcare Exchange will include five manufacturers: Johnson & Johnson (New Brunswick, N.J.), GE Medical Systems (GEMS of Waukesha, Wis.), Baxter International Inc. (Deerfield, Ill.), Abbott Laboratories (Abbott Park, Ill.) and Medtronic Inc. (Minneapolis). Eventually, the Exchange hopes to include more healthcare product providers.

The network will handle purchasing transactions for these companies. While the contracts are hammered out between manufacturer and customer, healthcare providers and institutions will select products from the catalogs of all five participants and make the transaction through Global Healthcare Exchange.

“Our customers have told us they want one global single source to streamline transactions combined with important clinical information,” said James Lenehan, chairman of medical devices, diagnostics and the health systems group at Johnson & Johnson. “They want a simple system that integrates with existing technology to reduce costs.”

One issue the Exchange addresses is healthcare customers’ requirement to contend with a variety of proprietary ordering systems between manufacturers. Abbott Chairman and CEO Miles White explained that this situation complicates the procurement process.

“The exchange will not only let customers enter and track the orders, but allow them to access correct contract pricing direct from the manufacturer,” White added.

The new organization also plans to work with major group purchasing organizations rather than compete with them to streamline the purchasing process.

“We’re trying to create enough flexibility here that if individual hospitals want to operate with the exchange, or if the GPOs wanted to participate, we could accommodate that,” said Harry Kramer, Baxter’s chairman and CEO.

Abbott’s White added that the Exchange would serve as a source of clinical information on products and technologies.

With such “major players” teaming up, the issue of monopolies is always a concern. Officials dismissed the idea that there may be legal implications to such extensive control of so many healthcare transactions. Similar purchasing organizations in other industries have come under such scrutiny.

Arthur Collins, president and COO at Medtronic, said the management team for the Exchange was expected to be finalized by April 30.

“We have already identified a CEO candidate, as well as a CFO, and we’re well along in the process of identifying the CIO,” Collins said. “The second step is getting our technology team up to date in developing the software required by this new enterprise.”

The Exchange is expected to go live in the fall and expand globally through 2001. The transition team consists of members of each participating company. The headquarters will be in Chicago.

MRI-related OEMs to partner on CV products

A trio of companies at the BIO 2000 conference in Boston set the stage to collaborate on the development of future contrast-enhanced cardiovascular MRI products.

“We have established a powerful network where MRI products and equipment development and marketing will be integrated from the start,” said Michael D. Webb, CEO of Epix Medical Inc. (Cambridge, Mass.). Epix’s partners are Vital Images Inc. (Plymouth, Minn.) and GE Medical Systems (GEMS of Waukesha, Wis.).

At the BIO 2000 conference, company officials detailed the strategy for creating partnerships and compatible technologies prior to FDA approval to streamline the development and acceptance of contrast-enhanced cardiac MRI. Panelists discussed clinical challenges in diagnosing cardiovascular disease and advances in 3D MRI technology.

SNM takes over administration, accreditation programs of ACNP

The Society of Nuclear Medicine (SNM of Reston, Va.) has agreed to assume the administrative functions of the American College of Nuclear Physicians (ACNP).

An agreement between the two groups which was approved by both boards last June was made final in March.

The ACNP and SNM will retain their legal and governance independence, but gain economies of scale in producing services and benefits for their respective members. SNM officials said the ACNP will focus on advocacy and socio-economic issues, while the SNM will concentrate on education and research activities.

SNM has extended its list to include accreditation. Separate from the ACNP administrative agreement, SNM has purchased the assets to practice accreditation and proficiency testing programs from ACNP. SNM plans to redesign the programs to become “more competitive with other offerings,” SNM’s statement read.

SNM has considered the move into accreditation in the past, but didn’t move on it, because ACNP handled most of that work. Last fall, SNM took over a $71,000 proficiency testing contract to inspect Veterans’ Administration (VA) facilities.

“We took that contract over from ACNP in the fall when they were having difficulties in their management,” said William Uffelman, director of public affairs and general counsel for SNM. Uffelman said SNM and ACNP always have shared members and he received inquiries from members asking if SNM could assist in the VA inspections. “So, we stepped in and got VA approval for us to become the contractor and handle that program.”

SNM certification includes an on-site inspection from a member of its quality advisory committee. Uffelman said the SNM also may include a paper-based inspection or reinspection process in the future, if members request it.

Uffelman said the inspection manual is being updated from its ACNP version to include new technologies and procedures. Currently, there are roughly a dozen inspectors dispersed nationwide to perform the inspections. The average cost of inspection for a single facility is $3,000, which gives SNM a new stream of revenue.

“We are a not-for-profit but it doesn’t mean we’re not allowed to make money,” said Uffelman. “It’s good business management for the association.”

Study: CT, MRI procedures to climb

The total number of CT and MRI procedures in the U.S. could reach 45 million this year, representing gains of 15 percent and 20 percent, respectively, in the two modalities.

That’s the projection from market research firm Technology Marketing Group (TMG of Des Plaines, Ill.) in its survey of more than 6,000 medical imaging sites.

TMG General Manager Mitch Goldburgh said the results show that CT and MRI markets continue to grow at a faster rate than radiology procedure volume in general. “New applications, continued diffusion of the existing applications to less-served markets and further integration of the technology into standards of clinical management bode well for the continued growth of these modalities,” he added, “as does their displacement of more expensive, more invasive procedures.”

TMG’s survey also indicated that 89 percent of CT procedures involve the head, neck, pelvis, abdomen, chest or spine. That percent volume is consistent with previous years. CT-guided procedures account for 5 percent of CT volume, with 62 percent of CT sites performing those types of procedures.

Eighty-five percent of MRI procedures involve the head, neck, spine or extremities. The number of sites performing procedures in other areas – principally chest, vascular, breast and cardiac – also are increasing.

TMG’s report also found that spiral/helical capability and multislice detector systems are major factors in CT purchase decisions. Open-bore systems are important to many MRI purchasers.

Philips, Intermagnetics General developing 3.0T MRI

Philips Medical Systems North America (Shelton, Conn.) unveiled plans for a 3.0 Tesla MRI system during the annual meeting of the International Society of Magnetic Resonance in Medicine (Berkeley, Calif.) in Denver in early April.

The new, more powerful, whole body, high-field MRI is being developed with long-time Philips collaborator Intermagnetics General Corp. (Latham, N.Y.), which will supply the 3.0T magnet to Philips. Intermagnetics has been working with Philips for close to 15 years.

“In May [1999], we signed a new agreement switching from a three-year contract cycle to a rolling five-year cycle, which means today there’s five years to go and next week there will be five years to go,” said Glenn H. Epstein, president and CEO of Intermagnetics. “It allows the management of the two companies to focus on the technology roadmap rather than positioning for contractual negotiations.”

Intermagnetics has designed the new magnet to fit within the same housing as its 1.5T magnet. Epstein said the design makes the integration process much easier for Philips and limits the delays in getting a product on the market.

“It will look the same as the 1.5T magnet,” said Epstein. “It will be heavier and be more costly because there is much more superconducting wiring in it to give it the strength.”

Philips plans to install the first 3.0T system at the University of Zurich (Switzerland), another longstanding Philips partner. Primary applications of the new system include cardiac applications and MRI-guided surgery, as well as functional brain imaging. According to Philips, the new 3.0T product will join the Intera product line, which includes 0.5T, 1.0T, and 1.5T products.

Intermagnetics said there should be “new products that produce incremental revenues beginning in 12 to 18 months.”

In the past year, several Philips’ competitors have announced plans to develop and sell a 3.0T MRI system.

Siemens Medical Systems (Iselin, N.J.) unveiled plans for a 3T system as part of the strategic alliance with Bruker Medical (Ettlingen, Germany) at the RSNA in 1999. GE Medical Systems (Waukesha, Wis.) received FDA clearance on the VH/i 3.0T MRI in May 1999.

In 1999, Marconi Medical Systems Inc. (Highland Heights, Ohio) acquired Surrey Medical Imaging Systems Ltd. (SMIS of Guildford, U.K.), which has developed technology for whole body imaging systems of 3.0 Tesla and 4.7 Tesla strength for research applications.

Marconi is targeting two markets – oncology and interventional MRI – with its more powerful systems, due out at the end of this year.

Heavy debt prompts Diagnostic Health Services to file Chapter 11

It may have been a classic example of “too much too soon” for medical outsourcing services firm Diagnostic Health Services Inc. (DHS of Dallas).

After acquiring more than a dozen other businesses in 1996 and 1997, the company now is struggling with a debt problem that has forced it to file for Chapter 11 bankruptcy protection.

Since December, DHS has eliminated approximately 25 percent of its employees, downsizing from 400 to 300 in that time. CEO Christopher L. Turner said layoffs have come in all areas of the company.

While Turner said DHS does not plan on changing its business model, the company has eliminated much of its third-party business. “We exited a portion, but not all, of the third-party pay business in markets where we experienced significant collection problems,” he added. “We kept the business where it made sense.”

Overall, Turner said DHS doesn’t expect the bankruptcy to affect existing customers and that the company plans to focus on its core business of providing diagnostic imaging services to institutional customers.

“We have a good core business,” Turner said. “We just have too much debt.”

The past year has been a turbulent one for DHS. While the debt problems are not new, a year ago it looked as if DHS was on the path to success with a promising merger in the works. In an attempt to alleviate its debt-heavy financial predicament, DHS signed an agreement to merge with Medical Alliance Inc. (Irving, Texas), another struggling outsourcing services provider, in February 1999.

In May, the companies restructured that deal, but, by August, the merger was dead in the water. That failed agreement cost DHS approximtaely $725,000 and the company was delisted from the Nasdaq stock market after first going public in 1996. DHS officials would not say if the company has received or currently is considering any other merger offers since the collapse of the Medical Alliance deal.

“We’re now examining every option to maximize the value of the company’s assets,” said Turner.

In January, DHS concluded a new financing arrangement with Unicapital Corp. (Miami) after DHS was in default on various loan agreements with its former senior lender and other debt holders. Also, at that time, DHS brought on turnaround consulting firm Glass & Associates Inc. to restructure the company and assist in making strategic decisions.

DHS also has had changes on the management front. In January 1999, Chairman and CEO Max Batzer left his position as CEO. At that time, Batzer said he felt the company had weathered the storm and it was an appropriate time to give up the reigns to President and COO Brad Hummel. By October – 10 months later – Hummel resigned as CEO and handed the company to new CEO Turner. Turner had served as CFO since May 1997.

New groups offer certification plan for refurbishers

“A code of ethics is no substitute for technical competence.”

With that statement, two new groups – Global Medical Network Inc. (Compton, Calif.) and the International Association of Certified Equipment Refurbishers (IACER) – have been created to regulate medical device refurbishers and foster international growth in the alternative medical equipment industry via the Internet.

Frank Tuft is the man with the plan. A retired industry veteran, Tuft devised the program when he realized the Internet’s potential economic value in selling pre-owned medical equipment. But, Tuft said, the “incredible efficiency of the Internet cannot be utilized unless there is confidence.”

With that in mind, Tuft established Global Medical Network, which is sponsoring the IACER.

The Web site for the Global Medical Network reads: “Our mission is to create conditions through which the potential of the Internet to reduce the cost of distribution of refurbished and excess medical equipment can be realized. The network is designed to provide responsible, independent service organizations the resources needed today and in the future to effectively market products worldwide.”

Membership in IACER demands that a business meet fairly stringent requirements. The criteria are intended to give buyers and sellers more confidence in transactions with IACER members than nonmembers. For example, IACER applicants must have workers’ compensation and product liability insurance. Applicants also must produce client, peer and bank references. IACER will run a credit report and intends to perform an on-site inspection of each applicant. A certificate of insurance and the credit report of each member will be on-file at IACER’s office.

“In other words, a good guy can buy the equipment and have some contract people come in and fix it, but that doesn’t mean that he can support it,” Tuft said. “Technical competence is established by performance. If someone’s been doing this work correctly, he will have no problem.”

While the plan has some of the same goals of the AAMI-sponsored voluntary regulation plan being considered by the FDA, Tuft, an industry veteran, said he had no knowledge of the plan or its goals or content.

Tuft said IACER has considered closely the membership cost that would be required to cover expenses of a credit report and on-site inspection. He feels that a $500 annual membership fee should be sufficient to offset IACER’s costs.

“There doesn’t have to be a lot of technical mumbo jumbo in this thing like different association certifications,” Tuft explained. “If the refurbisher has been doing the work successfully and has good relationships – he IS the expert.”

To further facilitate the exchange of equipment, Global Medical Network has established an online auction of medical equipment. According to Tuft, the only buyers who will be allowed to purchase items on the auction site will be IACER members who have passed membership requirements. He believes that the designation will give litigation-leery hospitals more confidence to offer their equipment online.

SAI gains momentum at ACC meeting

The Society of Atherosclerosis Imaging (SAI) is stretching its wings after debuting last November prior to the American Heart Association (AHA of Dallas) meeting. SAI held its second meeting before the American College of Cardiology (ACC of Bethesda, Md.) meeting in Anaheim, Calif., in March.

The SAI’s mission is to “promote and coordinate an integrated approach to atherosclerosis detection and prevention emphasizing noninvasive imaging and risk factor modification.” Its early work has focused on the evaluation of calcified coronary artery plaque using electron beam computed tomography (EBCT).

SAI President Harvey S. Hecht, M.D., director of preventive cardiology and cardiac imaging at the Arizona Heart Institute (Phoenix), said the focus on EBCT comes at a key time in the technology’s development.

“We are interested in the primary prevention of coronary artery disease,” Hecht told Medical Imaging. “Currently, the best approach for doing this is through the use of EBCT. Because we feel this is so important, we formed this association to facilitate this approval by firming up the scientific basis, by serving as a registry for data collected by EBCT and serve as the spokesman for the whole concept of plaque imaging.”

One of the SAI’s immediate goals is to create a database of 100,000 patients that have had EBCT exams and use that database to categorize future patients who have the exam. Putting patients into a specific percentile will add another risk factor for each patient, independent of his or her age.

“The percentile tells you how quickly or slowly your coronary arteries are aging,” said Hecht, adding that the database is near completion.

The commercial developer of the EBCT technology, Imatron Inc. (South San Francisco), is “obviously very interested” in the success of SAI, Hecht added, but SAI is not working in the interests of that company in particular, but more in the EBCT technology itself.

Imatron estimates there are more than 120 major medical centers using the company’s Ultrafast EBCT scanner.

EBCT was a hot topic at ACC this year. Twenty studies on EBCT were presented, the majority of which described routine technology evaluations and assessment of cardiac risk factors relative to EBCT. Hecht took part in a presentation at ACC emphasizing National Cholesterol Education Program (NCEP) guidelines for determining risk of heart disease.

The SAI is looking to gain the interest of all clinicians involved in plaque identification, not just EBCT-related ones.

Epidemiologists and lipidologists also are recruited as potential members of the SAI. Currently, there are approximately 100 members in the group.

SAI’s meeting prior to ACC brought in 75 attendees and featured a presentation by Zahi Fayad, assistant professor of radiology at the Mt. Sinai School of Medicine (New York), on the use of MRI to identify vulnerable plaque.

In February 2001, the SAI plans to hold its first international scientific meeting in San Diego. Hecht said the SAI is planning a two-day, multi-modality meeting. Details are not yet available.

FDA approves Varian’s SomaVision

d01b.jpg (10971 bytes)The FDA has cleared Varian Medical Systems Inc.’s (Palo Alto, Calif.) SomaVision software for planning and simulating cancer radiotherapy treatments, including Intensity Modulated Radiation Therapy (IMRT).

SomaVision software compiles medical images from CT scans into 3D images of tumors within patient anatomies. It enables radiation oncologists to visualize and simulate treatment plans on computer screens to optimize beam placement so that proper doses are delivered to tumors with minimal exposure and complications for surrounding healthy tissue.

SomaVision works with Varian’s suite of Generation 6 system products for planning, simulating, delivering and reviewing radiotherapy treatments, as well as managing patient records. It also works with CadPlan Plus and Helios inverse treatment planning tools that play roles in Varian’s SmartBeam technology for IMRT.

The software features geometric planning tools and dose mapping capabilities that allow for rapid reviewing and analysis of dose conformity in order to deliver high-resolution IMRT.

Interactive tool developed for X-ray system purchase

Photoelectron Corp. (Lexington, Mass.), developer of a miniature X-ray system for tumor therapy, has completed development of a reimbursement calculator to enable hospitals within the United States to prepare a financial model for purchasing one of its systems.

The interactive tool allows sales staff to work with clients to tailor a business case to treatment practice and provides data for Photoelectron’s Photon Radiosurgery System (PRS), as well as its recently launched Intrabeam and Accubeam systems.

Photoelectron’s reimbursement calculator uses combinations of Current Procedural Terminology (CPT) codes that reflect the variety of clinical procedures that it is possible to carry out with the X-ray source.

CPT codes are maintained by the American Medical Association (AMA of Chicago) and used by most insurers to process physician’s claims and outpatient hospitalization service claims.

The reimbursement models created by the calculator rely primarily on established CPT codes that describe medical services and procedures that the patient receives as part of standard treatment procedures using Photoelectron’s miniature X-ray system. The procedures considered include the clinical and scientific use of the system, as well as administration and management.

Chuck Vecoli, vice president of sales and marketing at Photoelectron, said the reimbursement calculator has been in development for almost a year. The original model was based on the use of the company’s device in the cranium. When Photoelectron received FDA clearance to use the device in the rest of the body, the company expanded the project to include intraoperative radiation therapy procedures.

“The calculator gives a basic set of codes that are appropriate for use with our device, and it provides the customer with a basic financial model that they can introduce to their administration and do their own internal calculations,” Vecoli said.

The calculator uses information from the CPT code and the coding initiative for the procedures that Photoelectron is able to perform with its device and data from the hospital regarding their specific practice and billing procedures. The calculator combines the two factors to devise a projection for return on investment.

“It is not intended to direct them on which CPT codes to use, nor is it intended to be a billing tool,” Vecoli said. “It’s really a calculator to determine the feasibility of purchasing our technology.”

Although it is not permissible for companies to recommend or promote CPT codes for clinical procedures, the calculator can be used by prospective purchasers to evaluate the potential reimbursement they could receive when the X-ray system is used.

News Briefs

Lernout & Hauspie (L&H of Burlington, Mass.) has set in motion its second acquisition in less than a month. The voice recognition technology company has signed a definitive agreement to purchase Dragon Systems Inc. (Newton, Mass.), which also specializes in speech and language technology. L&H is offering to acquire all of Dragon Systems’ stock for approximately 5.45 million shares of L&H stock. L&H stock rose $20 to $129 per share on the day of the announcement. Dragon Systems recorded revenues of $60 million and a net loss of $22 million in its fiscal year 1999. Dragon Systems has approximately 350 employees, half of whom are research scientists and development engineers. L&H also has a definitive agreement to acquire Dictaphone Corp. (Stratford Conn.), a privately held dictation and telephony call center recording systems company. L&H plans to buy the company for approximately 4.75 million shares of L&H common stock. The transaction was expected to close late April.

Agfa Corp. (Ridgefield, Park, N.J.) has inked an agreement to sell computed radiography (CR) equipment to the U.S. Department of Veterans Affairs at set prices, terms and conditions. The pact runs through March 31, 2001.

Tenet Healthcare Corp. (Santa Barbara, Calif.) has selected Masterplan (Chatsworth, Calif.) to handle CT and MRI maintenance services. The contract includes members of BuyPower, Tenet’s group purchasing organization. Tenet owns and operates 113 acute-care hospitals in 18 states.

The North Atlantic Treaty Organization (NATO) has assigned a part number to the SonoSite Inc.’s (Bothell, Wash.) hand-held ultrasound system, the SonoSite 180, making it available for purchase by NATO’s 19 member countries for use in military medicine. NATO added the system to its procurement list after field testing in an eight-week clinical trial during peacekeeping operations in Kosovo in 1999. The trial was used to assess the system’s versatility, portability, clinical utility, ease of operation, robustness and durability.

The FDA has cleared Hologic Inc.’s (Bedford, Mass.) instant vertebral assessment (IVA) on the company’s new Delphi QDR Series bone densitometer, based on the agency’s review of Hologic’s 510(k) premarket notification. Hologic presented data from a study by Drs. Harry Genant and Jacquie Rae comparing IVA with plain film for the detection of vertebral deformities. IVA study results demonstrated comparable specificity and sensitivity in identifying vertebral fractures at only 1 percent the dose of a lateral X-ray. IVA is designed for the rapid visual interpretation of vertebral status for markedly improved risk stratification beyond bone mineral density testing alone.

Medison America Inc. (Cypress, Calif.) has moved into a new 21,000 square-foot facility in Cypress, Calif. The new location is twice as large as Medison’s former headquarters in Pleasanton, Calif., and will house the company’s administrative offices, customer service staff and equipment service capabilities, as well as provide room for expansion.

Magna-Lab Inc. (Syosset, N.Y.) unveiled some updates on the development of its technology at the American College of Cardiology show. The company presented updates on the development of a minimally invasive catheter for MRI imaging of the coronary arteries. The company is working with the Zena & Michael A. Weiner Cardiovascular Institute of the Mount Sinai School of Medicine (New York) to develop new methods and devices to exploit MRI’s advantages in imaging soft tissue and detecting coronary artery disease. In addition to the minimally invasive catheter, Magna-Lab is developing a non-invasive transesophegeal probe for imaging coronary arteries.

A new MRI technique played a major role in a study reviewing the effectiveness of the psychological medication Ritalin. Researchers at McLean Hospital (Belmont, Mass.) used functional MRI to show that Ritalin restored function in children diagnosed with attention deficit hyperactivity disorder (ADHD). According to a report in the journal Nature Medicine, under functional MRI, the putamen region of the brain saw impaired blood flow in patients with ADHD who tested objectively to hyperactivity. Ritalin was found to enhance the blood flow in those patients significantly. Conversely, Ritalin decreased blood flow in those patients that did not test positive to hyperactivity.

Marconi Medical Systems (Highland Heights. Ohio) announced plans to complete the purchase of its Indian joint venture Network Ltd. (New Delhi, India). According to a company statement, Marconi plans to purchase the remaining shares of the company and make it 100 percent Marconi-owned. The company will formally change its name to Marconi Medical Systems India Ltd.

Fonar Corp. (Melville, N.Y.) has received FDA clearance to market its Fonar-360 MRI scanner. The 0.6-Tesla scanner features a unique magnet configuration that presents the scanner as a full room with two circular structures projecting from the ceiling and the floor. There is no structure between the patient and the walls of the room, giving the patient a clear view of the walls which can be decorated with one of several landscapes. Fonar went so far as to say in its statement that, “The patient’s experience of the scan will be more like a trip to the mountains than an MRI scan.” Fonar officials said the scanner also will provide a platform for the future interventional procedures.

GE Medical Systems (Waukesha, Wis.) has signed an agreement to become the sole-source provider of medical imaging equipment to Joint Purchasing Corp. (JPC of New York) and its subsidiary Creative Source Concepts (CSC of New York). According to Christine Sone, director of marketing and communications, the three-year deal covers all imaging equipment as well as patient monitoring equipment in a deal with GE Marquette Medical Systems Inc. (Milwaukee). JPC and CSC combined serve 1,900 acute care and freestanding facilities nationwide.

SonoSite Inc. (Bothell, Wash.) has entered into a manufacturing and supply agreement with Flextronics International Ltd. (San Jose, Calif.) under which Flextronics will assemble and test major subassemblies to be incorporated into SonoSite’s SonoHeart and SonoSite 180 portable ultrasound systems. According to Mike McNamara, president of the Americas at Flextronics, the agreement is part of a strategy to grow Flextronics more into the medical market.

Mid-Atlantic Group Network of Shared Service Inc. (MAGNET of Mechanicsburg, Pa.) has signed a three-year, sole-source agreement with Toshiba America Medical Systems Inc. (Tustin, Calif.) for cardiovascular and diagnostic ultrasound systems. MAGNET’s GPO members may purchase the equipment at negotiated group discount prices from Toshiba’s full line of ultrasound products. MAGNET has 12,000 members in 20 states.

Immunomedics Inc. (Morris Plains, N.J.) has filed a patent infringement lawsuit against Cytogen Corp. (Princeton, N.J.) and C.R. Bard (Murray Hill, N.J.) alleging that Cytogen’s ProstaScint imaging agent infringes on an Immunomedics patent. Bard co-markets ProstaScint, an imaging agent used in the detection of prostate cancer. Cytogen fired back a statement saying it believes the suit is “without merit” and that the Immunomedics patent has expired. In a prepared statement, Cytogen said it “believes this patent is unenforceable and invalid.”

Sonus Pharmaceuticals Inc. (Bothell, Wash.) has received an action letter from the FDA requesting a reanalysis of certain data that may affect product labeling of its EchoGen ultrasound contrast agent. The FDA gave Sonus an approveable letter in April 1999 saying EchoGen could be approved when certain conditions were satisfied. Michael Martino, president and CEO of Sonus, expressed “surprise” at the FDA’s request, adding that the company “felt we had addressed all of the FDA’s concerns in our September 1999 submission and in subsequent conversations with agency reviewers.” Martino said Sonus will meet with FDA officials and try to work as quickly as possible towards final FDA approval. The company’s application to the FDA is for the use of EchoGen in the echocardiographic evaluation of left ventricular endocardial border delineation and left ventricular chamber opacification.

Group purchasing organization AmeriNet Inc. (St. Louis) has signed an agreement to offer its member facilities mammography systems from Instrumentarium Imaging (Milwaukee). The agreement becomes effective April 1.

Mecon Inc. (San Ramon, Calif.) has changed its name to reflect the company’s purchase by GE Medical Systems (Waukesha, Wis.) in February. Mecon becomes GE Medical Systems Healthcare Solutions and will remain in its current California location.

ADAC Laboratories Inc. (Milpitas, Calif.) has signed a marketing and development agreement with Seattle Systems Inc. (Oakland, Calif.) under which the two firms will jointly develop and market the capability to transfer clinical data between ADAC’s nuclear medicine cameras and Seattle Systems’ cardiovascular information management systems. The companies will develop interfaces to integrate nuclear cardiology images from ADAC’s gamma cameras with other patient data stored on Seattle Systems’ Apollo cardiovascular data repository. The two firms also will develop jointly decision support tools for nuclear cardiologists and referring physicians and explore the development of e-commerce products and cardiac cath lab products.

Richardson Electronics Ltd.’s (LaFox, Ill.) Medical Systems Group introduced two new large-field image intensifier replacements based on the Thomson TH9447HX image tube. One is designed for replacing Philips Medical Systems’ 36 to 38-centimeter image intensifiers. It utilizes an original Philips housing reloaded with the Thomson image tube. The other new offering is for Siemens Medical’s 40-centimeter image intensifier and uses a Thomson housing and tube. Richardson also has signed an agreement to distribute medical imaging displays for Siemens AG (Karlruhe, Germany) Display Technologies group. The deal covers distribution in North America and most of Europe and Asia. The Siemens products will be offered as part of Richardson’s RELLmed Bundled Systems, which provides fully configured computer hardware, video controller cards and high-resolution display monitors.

Lumisys Inc. (Sunnyvale, Calif.) has released the DI-2000 version 4.0 of its acquisition and viewing software. The software is included with Lumiscan desktop digitizers and the ACR-2000 DesktopCR system. Among the improvements in the new version are a group send capability to route a single image to multiple destinations and a speed send option to let users send images from the image review window. An automatic window/level control has been added to further enhance user productivity and automatically adjust images to optimum settings.

Executives on the move

Dornier Medical Systems Inc. (Kennesaw, Ga.) has appointed Brock Faulkner as vice president of business development. Faulkner’s responsibility will be the expansion and diversification of Dornier’s service business.

Fischer Imaging Corp. (Denver) has appointed Kenneth E. Crocker as marketing manager for mammography. Crocker previously served at Eastman Kodak Co. (Rochester, N.Y.) since 1982. Most recently, he was director of business planning for mammography and oncology and U.S. mammography marketing manager.

Sonus Pharmaceuticals Inc. (Bothell, Wash.) has promoted Richard J. Klein to vice president of finance and controller. Klein has served as Sonus’ director of finance since 1996. The move comes in conjunction with Sonus’ announcement that Gregory Sessler has resigned his position as the CFO to pursue other business activities. Sessler had been with Sonus for five years.

The Healthcare Information and Management Systems Society (HIMSS of Chicago) has named H. Stephen Lieber, CAE, as its new executive director. He replaces John Page, who resigned in July 1999. For the past two years, Lieber has served as vice president of the division of personal membership groups at the American Hospital Association (AHA of Chicago).

The Health Industry Distributors Association (HIDA of Alexandria, Va.) has named Matthew J. Rowan as president and CEO of HIDA. Rowan has served as acting CEO since December after replacing former CEO S. Wayne Kay, who left HIDA for another opportunity in the healthcare industry. Kay served as HIDA’s president and CEO since early 1994.

ATL Ultrasound (Bothell, Wash.) has promoted William Doherty to vice president of global cardiology business development. Doherty most recently served as vice president of U.S. cardiology sales. ATL also announced that Bob Dockendorff, vice president of North American sales, will assume the additional duties of the U.S. cardiology sales organization. ATL has named Allan Criss to Doherty’s previous post of vice president of U.S. cardiology sales. Criss most recently served as director of eastern U.S. sales. Inc. (Santa Clara, Calif.) has named a new CTO to head up the company’s technological development. Maher Hakim comes to from his position as founder and CTO at Pharos Technologies Inc. (San Francisco) which was acquired by in January. Pharos specializes in building Internet infrastructure solutions for business to business e-marketplaces.

The Thomas Group (Anaheim, Calif.) has hired Ron Averitt as a consultant. Over the last 20 years, Averitt has represented ISOs, OEMs and diagnostic healthcare providers specializing in high-tech digital applications.

Former Trex employees open Quantum Medical Imaging

Sometimes things look darkest before the dawn.

When Trex Medical Corp. (Danbury, Conn.) announced in May 1999 that it would close its Bennett X-ray subsidiary (Copiague, N.Y.), it looked like the end of the road for many Bennett employees. But now a new company has surfaced, founded by a former Bennett vice president and several other high-level Bennett people.

Quantum Medical Imaging LLC (Bohemia, N.Y.) is the brainchild of Scott Matovich, who was an associate vice president of domestic sales for Trex Medical when it shut down the Bennett facility and consolidated its operations into Trex’s Danbury and Littleton, Mass., facilities.

“There was a very tight-knit group of people here on Long Island,” Matovich said of his former Bennett co-workers. “I knew we all enjoyed this business and we’re very good at it, so we decided to go back to what our heart told us to do.”

The idea hatched and Matovich attended the annual meeting of the Radiological Society of North America (RSNA of Chicago) in November to test the waters. He talked with radiography distributors and saw a desire among them for a new manufacturer in the ever-consolidating radiography market.

“Ten years ago, there were eight to 10 competitors in this business,” said Matovich. “Today, in the radiography business there are very few. In fact, there are more distributors than manufacturers and that’s created something of a log jam. That gave us the idea that there are some great dealers out there that don’t have a product they exclusively can sell.”

In the weeks following RSNA, Matovich got in touch with some of his former co-workers at Bennett and went ahead with the formation of Quantum.

Quantum currently has about 20 employees and is developing prototype radiography products. The company’s plan is to focus exclusively on radiography products, starting with conventional systems and moving into flat-panel digital radiography systems in the future.

“As digital imaging becomes more important and takes off, people will want to put those receptors into some high-quality X-ray systems,” Matovich said. “We’re trying to put the spark back in the standard radiographic system by using some new technologies and new features. We want to keep our focus on the digital imaging platform that will be the future of this business.”

Quantum is in the process of finalizing a lease on a 25,000 square foot manufacturing and R&D facility which it hopes to move into later this month. From there, Matovich expects products to start rolling out by mid-summer.

Joining Matovich are Dennis Iuliucci, a 20-year employee of Bennett, who has signed on as the vice president and general manager at Quantum. Quantum’s vice president of engineering is Shalom Cohen, who previously served as product development manager at Bennett.

AIUM show strives to bring ultrasound back into public eye

While more complicated imaging technologies like CT and MRI have been gaining notoriety lately, the 44th annual convention of the American Institute of Ultrasound in Medicine (AIUM of Laurel, Md.) held in San Francisco in April sought to bring ultrasound back into the public eye and increase public awareness of the technology.

photoGEMS showed the Logiq 400 Pro Series at AIUM in San Francisco.

To that end, AIUM declared October as Ultrasound Awareness Month, toting a theme of “Ultrasonography – Sound Images from Head to Toe.” A statement from AIUM said that while many people are familiar with ultrasound during pregnancy, few know about the broader applications the technology offers.

One of those applications was highlighted at AIUM in a press conference held by Christopher F. Njeh, Ph.D., assistant adjunct professor at the University of California, San Francisco department of radiology. The presentation highlighted the movement to use quantitative ultrasound (QUS) in assessing bone mineral density over dual X-ray absorptiometry.

According to a statement from the press conference, “Studies have established that QUS variables such as speed of sound and attenuation in bone are related to the bone density and bone structure.” The statement also said there is evidence to support the use of ultrasound to study skeletal status in children and other medical conditions such as rheumatoid arthritis.

photoThe Hitachi 6000 digital ultrasound system debuted at the show.

Beryl Benacerraf, M.D., was awarded the AIUM’s William J. Fry Memorial Lecture Award at the conference for her contributions to the progress of ultrasound. Benacerraf presented a lecture titled “Sonographic Detection of Fetal Down’s Syndrome: Past, Present and Future” at AIUM, saying the field of detecting aneuploidy by prenatal ultrasound has “mushroomed,” providing an effective method for screening for Down’s Syndrome.

On the commercial side, GE Medical Systems (GEMS of Waukesha, Wis.) claimed an industry record fourth quarter sales of $212 million in ultrasound, propelling the firm to the top spot in the industry, according to GEMS officials. GEMS has reported 30 percent growth in ultrasound for the past five years and said 1999 was a record year in cardiac ultrasound sales.

Product-wise, GEMS was showing its new Logiq 400 Pro Series, a mid-range ultrasound system that can be upgraded to the Logiq 700 level. The 400 Pro uses a digital beam former, wideband multi-frequency transducers and Micron Imaging capability. It also uses Tissue Harmonic Imaging migrated from the Logiq 700 system and 3D View capabilities.

Hitachi Medical Corp. of America (Tarrytown, N.Y.) was showing its Hitachi 6000 platform in San Francisco which uses a Windows NT operating system and a digital beam former with 256 channel quad processing. Features on the 6000 include tissue harmonic imaging, directional CFA and enhanced artifact suppression algorithms.

Molecular Biosystems regroups with layoffs, cuts

A failed merger attempt has forced ultrasound contrast agent developer Molecular Biosystems Inc. (MBI of San Diego) to restructure the company, laying off more than half of its employees and eliminating product development efforts as a result.

A decision by Palatin Technologies Inc. (Princeton, N.J.) in March to terminate its merger agreement with MBI made the restructuring necessary, said Patricia Sullivan, MBI manager of investor relations and corporate communications.

“Basically, right now, we have to conserve our cash and, of course, we had to cut back on our expenses,” Sullivan said. “One way to do this is with the layoffs we have had.”

Thirty-three of MBI’s 56 employees have been let go. Of the remaining 23 people, the majority will be involved in the continuing transfer of manufacturing to Mallinckrodt Inc. (St. Louis), Sullivan added. “I would say less than 10 are going to be remaining [in San Diego] after we transfer manufacturing, so the company will be very small.”

Restructuring plans also call for MBI to abandon any new product-development activities and focus exclusively on Optison, the company’s cardiac ultrasound contrast agent and flagship product.

As a result, MBI has eliminated development of MB840, a CT liver selective imaging agent, Sullivan said. The company also has eliminated its oral ultrasound contrast agent Oralex development program and is licensing the product to Chugai Pharmaceuticals (Tokyo), MBI’s Asian distribution partner.

“All activities going forward will be focused on Optison,” Sullivan said.

MBI had completed its myocardial perfusion Phase Two studies of Optison and submitted the findings to the FDA in September 1999. Before beginning Phase Three studies, however, MBI must meet with Mallinckrodt, MBI’s marketing partner for Optison in Europe and the United States, Sullivan said.

“We announced in November 1998 that we were going to outsource manufacturing to Mallinckrodt, and [Mallinckrodt] also pays for the clinical development of Optison,” she said. “That is why we have to sit down with them and evaluate before we move into Phase Three for Optison.”

The changes at MBI do not reflect on the market for contrast agents, Sullivan said.

“I believe there is a market for contrast agents; it’s just that it is a very slow ramp-up, slower than anybody expected,” she said.

MBI reported a 43 percent increase in Optison sales in its fiscal third quarter, ending Dec. 31, 1999, as compared with the same quarter of FY98.

Sullivan declined to comment on the future course of the company.

“Right now, the CEO [Bobba Venkatadri] and our executive vice president are working on a few options. They will sit down with the board and then move forward,” she said. “But, at this point, I am not at liberty to discuss any of those options.”

MBI has been in existence since 1980. MBI’s Albunex, a first-generation agent, and Optison, its replacement, were the first contrast agents approved by the FDA.

Imaging vendors spare no expense to woo ACC attendees

d01e.jpg (11130 bytes)Imaging companies were more visible than ever at the American College of Cardiology (ACC of Bethesda, Md.) 49th scientific sessions in Anaheim, Calif., in March.

Siemens Medical Systems Inc. (Iselin, N.J.) displayed its recently FDA-cleared Magnetom Sonata, a dedicated cardiovascular and neurovascular MRI system. The Sonata is a 1.5 Tesla scanner, which offers whole-body MR angiography capabilities, high-resolution 3D imaging for multi-planar viewing and faster gradients.

Siemens had researcher Paul Finn, M.D., of Northwestern University Medical School (Chicago) on hand to talk MRI. Finn said he feels MRI may one day replace X-ray methods for a variety of angiographic applications and provide quality diagnostic information in ischemic heart disease.

Siemens also unveiled its ACom.Web multi-modality image distribution network. ACom.Web allows users to combine cardiology and radiology images and display the images on an ordinary personal computer via the Internet. ACom.Web works with existing software and hardware, providing an economical method to distribute images from all modalities.

The wraps were taken off a new Siemens cardiology program called Alliance for Cardiac Excellence. The program seeks to offer a portfolio of diagnostic and interventional equipment, information technologies and systems integration to drive process improvements in cardiac disease management. Tom McCausland, Siemens’ president and CEO, said the new program’s mission is to help cardiac care providers manage both clinical and financial outcomes using data from a variety of different sources.

Acuson Corp. (Mountain View, Calif.) highlighted its KinetDx PACS system, which began shipping in December. KinetDx is a hospitalwide dedicated echocardiography and ultrasound image management system. The system provides complete review, report and archive capabilities to make the digital laboratory a practical reality for echocardiography and ultrasound departments.

Camtronics Medical Systems Inc. (Hartland, Wis.) rolled out its Vericis for cardiac cath system. The Vericis image and information management system debuted last November. Gene Bergholz, president of Camtronics, said the Vericis architecture is designed to provide for efficient integration of images and information from multiple cardiac sources.

Toshiba America Medical Systems Inc. (TAMS of Tustin, Calif.) demonstrated its e.soft nuclear medicine workstation for the E.Cam gamma camera at ACC. E.soft is a joint development project with Siemens and is designed to enhance patient throughput. The workstation comes equipped with gated SPECT myocardial assessment, gated blood pool SPECT studies and profile attenuation correction.

Toshiba also displayed its PowerVision 8000 ultrasound system for cardiac applications. The 8000 features the PowerView package, a digital information management system that advances diagnostic capabilities.

Mobile P.E.T. Systems Inc. (San Diego) exhibited the first mobile cardiac PET system dedicated for cardiologists. Mobile PET worked with Positron Corp. (Houston), a developer of cardiac PET (positron emission tomography) systems and software, to develop the scanner. Other partners include Bracco Diagnostics Inc. (Princeton, N.J.), maker of the myocardial perfusion agent Rubidium-82, and Calumet Coach Works (Calumet City, Ill.).

Agilent Technologies Inc.’s Healthcare Solutions Group (Andover, Mass.) showed improvements to its Sonos 5500/4500 digital echocardiography systems as a works-in-progress. The improved capabilities include enhanced harmonic and contrast imaging and Soft Echo using new Ultraband transducers.

Agilent also demonstrated new capabilities for its EnConcert echocardiography image-management system as a works-in-progress. The improvements are expected to be available later this year and include connectivity enhancements, improved image handling, expanded measurements and more flexible reporting options.
SonoSite Inc. (Bothell, Wash.) offered its SonoHeart echocardiography system, touting a new distribution deal with its former parent, ATL Ultrasound (Bothell), a Philips Medical Systems Co. The 5.4-pound system produces all-digital PowerMap directional color power Doppler images on demand.
SonoSite also promoted a study, which found that a brief, focused echo exam with the SonoHeart could improve the accuracy of referral for comprehensi