FDA Clears Positrigo’s NeuroLF Brain PET System
Positrigo’s NeuroLF brain PET system, which aids in diagnosing brain disorders, has received U.S. FDA clearance and the company is increasing production to meet demand.
Tag: FDA clearance
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FDA OKs Siemens Healthineers’ syngo Virtual Cockpit
Siemens Healthineers has nabbed U.S. FDA clearance for syngo Virtual Cockpit, a secure platform for real-time image collaboration among healthcare professionals across different locations.
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FDA Proposes Major Changes to Medical Device Quality Regulation
The U.S. FDA published a proposal on why U.S. medical device quality regulations should be overhauled to be more akin to global regulations.
FDA Clears Zebra Medical Vision’s Coronary Artery Calcium Technology
On the heels of last month’s revelation that it will be acquired by Nanox, Israel-based medical imaging analytics company Zebra Medical Vision announces that it has received U.S. FDA 510(k) clearance for its coronary artery calcium technology, HealthCCSng.
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FDA Clears Globus Medical’s Three-in-One Imaging System
Audubon, Pa.-based Globus Medical, Inc. announces that the U.S. FDA has granted 510(k) clearance to the Excelsius3D intraoperative three-in-one imaging system, which consolidates 360-degree cone-beam CT, fluoroscopy, and high-resolution digital radiography.
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FDA Clears Siemens Healthineers Magnetom Free.Max 80 cm MR Scanner
Siemens Healthineers officials say the Magnetom Free.Max facilitates MR scanning for extremely obese and claustrophobic patients.
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FDA Clears Philips SmartCT 3D Application software
Amsterdam-based Royal Philips announces that it has received 510(k) clearance from the U.S. FDA for its Philips SmartCT application software.
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FDA Clears Diagnostic AI Tool for Identifying Early-Stage Lung Cancer
Virtual Nodule Clinic empowers clinicians to make optimal clinical decisions in early-stage lung cancer diagnosis and is now commercially available in the United States.
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