Images from top: Radiographic Digital Imaging, Inc.’s cd digitizer, the Cobrascan 2000 SL; Howtek’s CIS digitizer, the Fulcrum; Array Corp., USA’s 2905 Laser Film Digitizer; Vidar Systems Corp.’s DiagnosticPro Plus

For all its many upheavals, the film digitizer industry seems like it’s been around forever. But it is far from old. In fact, it’s barely a teenager.

In its dawning in 1990, it comprised several companies that made laser scanners for converting analog images to digital. Laser technology was soon joined by CCD, and the original manufacturers were joined by newcomers. Then along came mergers, buy-outs and disruptive technologies such as DR that whittled down the flock. By 2000, a mere handful of players remained to battle each other for market share, competing all the while to ramp up the capabilities of the available two technologies.

In just the past year, the landscape has again changed dramatically. Another corporate farewell, a promising new technology, and an industry-wide shift in marketing goals have kept everyone on their toes.

So while film digitizers still play a pivotal role in advancing PACS and teleradiology, both of which are going full tilt right now, vendors realize that film itself may fall by the wayside eventually (though no time soon). The heated-up race to carve out new markets is what really makes the digitizer sector fascinating to observe.

Dollars and sense
Teleradiology and the conversion of film libraries to PACS top the list of current uses for general-purpose digitizers. Many facilities also find them invaluable for managing films that patients bring in from elsewhere. And while every organization that desires to go filmless can’t afford to replace its analog modalities, a digitizer may well be within financial reach.

Here are two more reasons why digitizers remain popular: They help drive down the cost of general radiography and improve patient satisfaction with it. Business research firm Frost and Sullivan (San Jose, Calif.) states that “General radiography is the largest cost contributor and one of the most inefficient applications for radiology departments. In today’s managed-care environment, healthcare organizations continue to look for ways to contain costs, improve operating efficiencies, and increase patient satisfaction.” Going filmless, say Frost and Sullivan analysts, is perceived as the best way to do the job.

Until last year there were two basic types of technologies available for digitizing films, and everyone was familiar with them. There are the laser models, such as those made by Kodak Health Imaging (Rochester, N.Y.) and Array Corp. USA (Sparta, N.J.). They work with a laser that illuminates the film and a photomultiplier used as the detector. The other kind is CCD, or charge-coupled device digitizer, like those made by Howtek Devices Group (Hudson, N.H., a division of iCAD, Inc. in Tampa, Fla.), Canon USA Medical (Irvine, Calif.), Vidar Systems Corp. (Herndon, Va., a division of Contex Holding AS in Denmark), and Radiographic Digital Imaging Inc. (RDI of Torrance, Calif.). CCDs use fluorescent bulbs to shine through the film, with CCD arrays used as detectors.

CCD was the later entry of the two. Whereas laser is now a mature, refined technology whose most recent improvements concern speed and user interface, CCD has been tweaked for better pictures since its introduction. After an awkward period of catch-up, CCD vendors now claim it offers comparable image quality to laser. Laser has emerged the faster of the two, CCD the least costly. Each technology has its strengths, as well as its fans. Many facilities use both.

And that was pretty much the way things stood until Canon announced in February that it was discontinuing its PACS digitizer and leaving the market primarily to Kodak, Array, Howtek, Vidar and RDI. Is Canon’s abandonment evidence of an aging market?

Not really. Teleradiology use is increasing rapidly, plus there’s still tons of film to be digitized and, apparently, there will be for a long time. Canon’s change of direction is really more a portent of a bigger future – one that looks to a market far less saturated with solutions, a market that may revolutionize healthcare the way digitization did a while back.

CAD invasion
Though it has divested its lower-end digitizer business, Canon continues to manufacture the Canon 300++, a customized, 50-micron CCD digitizer. It is used exclusively by R2 Technology (Los Altos, Calif.) in its ImageChecker computer-aided detection (CAD) system for mammography. CAD is a computerized reader that relies on film digitization when added to analog mammography. It improves early breast cancer detection by 20 percent or more. R2, the first CAD vendor, has shipped some 750 systems since receiving FDA approval in 1998 to market the technology.

Some 900 CAD systems by three makers are now installed nationwide, quite a gain from zero commercial installations in 1997. Most CAD systems include digitizers. Only about 10 percent of 9,200 MQSA-certified mammographers currently utilize CAD, which leaves plenty of room for CAD vendors to move into that territory. Originally intended to provide healthcare providers with a liability hedge against false negatives, the technology had stirred up plenty of interest even before clinical studies proved it was also a boon to early cancer detection. CAD exam reimbursement was increased in March by 7.8 percent, from $17.14 to $19.13, further piquing clinical interest in the technology.

At the moment, only three companies have FDA approval to market CAD systems: R2, iCAD and CADx Medical Systems (Laval, Quebec, Canada). But a number of other vendors, including Fujifilm Medical Systems (Stamford, Conn.) and Scanis Inc. (Foster City, Calif.), have already developed their own versions that await FDA approval. In addition, some vendors are making their existing products CAD-ready. Among them is the MV-SR 657 viewing station for CR mammography from Fujifilm.

 Howtek’s Multirad 860 digitizer.

CAD/digitizer synergies are briskly rolling along. R2 has technology partnerships with GE Medical Systems (GEMS of Waukesha, Wis.), Lorad in Danbury, Conn. (a division of Hologic Inc. of Bedford, Mass.), Siemens Medical Solutions of Malvern, Pa., and Fischer Imaging Corp. of Denver. iCAD’s MammoReader, a high-speed CAD system with twin MultiRad film digitizers from Howtek, was approved by the FDA last year and quickly became part of a contract agreement with the U.S. Defense Supply Center (Philadelphia). CADx’s new Second Look CAD system also incorporates Howtek’s MultiRAD digitizer.

Crowded house
RDI has joined the CAD movement, too, marketing its new Cobrascan CX-2000SL CCD product as a CAD digitizer. It has an auto-calibrating 16-bit scanner that provides an optical density range of up to 4.8 and optical resolution of 13.7K, nearly seven times the standard (2K, or 2.5 lp/mm) set by the American College of Radiology (ACR of Reston, Va.). It can scan a 2x2K 150-dpi image in 10 seconds.

At the 2002 RSNA meeting, Vidar entered the CAD sweeps by introducing CAD Pro, its new CCD mammography digitizer. It has a 200-sheet film feeder and can process a four-film case in under 90 seconds. CAD Pro is being used in clinical studies conducted by Siemens at the Mayo Clinic (Jacksonville, Fla.) that will compare digitized and hard-copy images for quality. Vidar plans to eventually introduce CAD Pro into the PACS, teleradiology and oncology markets.

Howtek, like Canon, RDI and Vidar, is also sizing up the CAD market. It already had a major stake in the mammography sector with its MultiRad 860 digitizer, which is increasingly popular for CAD applications because of tight specs that enable it to shake off lighting and power fluctuations that can affect image quality. Recently the company expanded its mammography offerings with an even faster, higher-resolution CAD digitizer called Fulcrum. It’s not CCD, says the company, and it’s not laser. So what is it, then?

Last August the FDA approved what Howtek calls a continuous imaging strip (CIS) digitizer, a.k.a. Fulcrum. Unlike CCD, which works with a 1- or 2-inch sensor and a lens, CIS utilizes a full-width sensor with no lens. It has an exposure time of 250 scan lines per second, enabling Fulcrum to expose a 14×17 image in 9.4 seconds, which is twice as fast as MultiRad. And the optical density is 4.4, compared with MultiRad’s 3.85 optical density. Fulcrum comes in a package that’s 6.5 inches deep, 13 inches high and 18 inches wide, which is relatively tiny.

Howtek’s journey down a road less traveled was inspired, ironically, by film — the very thing digitizers were designed to eliminate. The newest x-ray films have increased ability to register black that is some 10 percent better than that of previous generations. Kodak’s X-Sight G/RA and L/RA and MIN-R 2000 films have a dMax of 4.0-plus. So does Fujifilm’s AD-M film. These new ultra-high-density media are well suited to mammography. They are particularly useful, as it turns out, for mammography CAD.

Grayscale range and optical density improvements are ongoing endeavors of digitizer and film manufacturers, since those attributes improve the radiologist’s perception and detection capabilities. Better and better film, however, begs a long-term commitment from digitizer vendors to keep technological pace as the bar rises ever higher on optical density. Those numbers have nowhere to go but up, especially as CAD applications increase. According to Howtek, that’s exactly what motivated the company to design Fulcrum, which actually has more dynamic range than the highest-density mammography film available. For now.

General imaging
With PACS penetration into hospitals at only about 20 percent, there’s plenty of room in that market for digitizer makers to maneuver and thrive.

Howtek’s bread-and-butter CCD line, MultiRad, still sells well. While the 860 is used primarily for mammography and orthopedics, the 460 is a lower-priced option with many of the same features as the 860. The 460 is therefore popular among telerad users. It digitizes films up to 4K resolution, twice the diagnostic quality required by the FDA for primary reading. It does 2K images at high speed, and can be used for both quick wet reads and in-depth reads.

 Kodak Health Imaging’s LS 85 Digitizer.

Array markets a PACS/telerad digitizer as well, the Array 2905. It’s based on a helium neon laser technology and can scan a 14×17 film at 2K resolution in 7 seconds, providing 4.0 optical density. At the 2002 RSNA meeting, Array introduced DICOM Scan Pro Plus, a software tool upgrade that corrects anatomic positioning, allows users to customize the storage order of scanned films, and enables deletion and undeletion of filed images to ensure they are correctly associated with the patient on the PACS. The package also includes a moire filtering tool for managing grid lines on radiographic films and log file tools to track the success of DICOM storage and duplication. It adds editing features to the base of body parts for patient demographics, and users can print as well as store digitized images.

RDI’s Cobrascan CCD line addresses PACS/telerad applications, too, with its compact CX-312SL and CX-612SL models. The 612 is a wall-mountable 16-bit scanner providing 3.6 optical density; the 312 is a 12-bit scanner that gives 3.3 OD and is designed for mobile clinics and emergency rooms. Both can scan a 2x2K 150-dpi image in 12 seconds.

RDI was founded 13 years ago by a former Lumiscan 20 designer who departed parent company Lumisys, Inc. to experiment with CCD, the newer of the two technologies at the time. Lumisys was the first company to market medical image digitizers, eventually offering both laser and CCD types. The company was acquired by Kodak in 2000. RDI sided with CCD, while Kodak now sells laser digitizers exclusively.

The line formerly known as Lumiscan is now owned and marketed by Kodak as its LS line. It consists of the LS 40, LS 50, LS 75, and LS 85 models. All are laser digitizers designed specially for telerad applications and PACS management. Each has a logarithmic amplifier that enhances grayscale at higher densities. The top-of-the-line LS 85, for instance, provides 5K resolution up to 4.1 optical density.

The LS digitizers are tabletop units that remain favorites among many PACS vendors and distributors. The list includes GEMS, eMed Technologies (Lexington, Mass.), Diagnostic Imaging (Jacksonville, Fla.), Richardson Electronics (LaFox, Ill.), Brit Systems (Dallas), and DR Systems (San Diego).

Digitizers in action
For a good example of how healthcare providers make efficient use of digitizers, consider X-ray X-press Corp. in Houston, which has an army of them. The company operates its own imaging center, hosts teleradiology service for 30 remote clinics and 12 hospitals around Texas, and provides mobile radiology to nursing homes. The X-ray X-press network includes 27 LS 75s from Kodak.

Dhruv Chopra, director of operations, says, “We’ve been using digitizers since ’96. We have eight radiologists working with us who read about 1,500 exams per day; maybe 1,000 are plain film x-rays. That’s about 30,000 a month” that are digitized.

“When we first started the business,” says Chopra, “the main radiologist used to go to different facilities and read x-rays for them. But as it became more cumbersome, he looked into teleradiology equipment.” And so began X-ray X-press’s transition from film to digital. “Everything at our imaging center is totally digital. We used to be very heavily dependent on film, but as time went on, we realized the cost savings associated with going digital.

“We’re using Easy Pax Inc. [Toronto, Ontario, Canada] as our teleradiology vendor for remote sites,” says Chopra. “They modified their product to suit our needs. We have radiologists reading exams and we also supply teleradiology equipment to other facilities. We have our own technologists on sites on many occasions, so we have to cater to their needs; they want a system that is not cumbersome to use. And we have to cater to the radiologists’ needs; they want a system that produces excellent images.

“We’ve been using LS digitizers and our dependence on them is very high. We’re very pleased with the images.” The LS 75 converts film images up to 14×17 into digital images of up to 4,096 pixels x 5,000 lines.

X-ray X-press also is test-driving a couple of CCD digitizers from Vidar to see whether auto-calibration lives up to its press. Vidar’s line-up includes five models: DiagnosticPRO Plus and Sierra Plus for general imaging, MammographyPRO Plus, and the new VXR-16 and VXR-16 DosimetryPRO for use in radiation treatment planning and delivery. The line features 12-bit and 16-bit image processing with up to 3.85 optical density courtesy of proprietary technology the company calls high definition CCD, or HD-CCD. All the models are lightweight desktop units that calibrate themselves. Sierra Plus, which is also wall mountable, was recognized for industrial design excellence by the Industrial Designers Society of America.

Among the vendors adding Vidar digitizers to their PACS solutions are eMed, Fujifilm, GEMS, Kodak, Philips Medical Systems (Bothell, Wash.), and ALI Technologies (a division of McKesson Medical Imaging in Richmond, B.C., Canada). Sierra Plus and DiagnosticPro Plus are standard components in the Impax TS 5 transmit/preview station from Agfa Healthcare (Ridgefield Park, N.J.), as well as in Siemens image management systems and the Scanning Workbench digitization station from Brit Systems Inc. (Dallas). Vidar currently has an installed base of 7,000 units.

There was speculation early on that, as analog modalities were retired in favor of digital ones, there would be proportionately less film and subsequently less need for digitizers. But the reality is that, as electronic imaging increasingly becomes a fact of clinical life, digitizers continue to find homes.