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FDA Cites GE Healthcare Cybersecurity Issues

[ Price : $8.95]

FDA highlights potential cybersecurity vulnerabilities in some GE Healthcare Clinical Information Central Stations and Telemetry S...

Class 2 for Computer Triage/Notification Software

[ Price : $8.95]

Federal Register notice: FDA classifies radiological computer-aided triage and notification software into Class 2 (special control...

CADx Software for Suspect Cancer Lesions Into Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies the radiological computer-assisted diagnostic (CADx) software for lesions suspicious for c...

Medical Image Analyzers Reclassified as Class 2

[ Price : $8.95]

Federal Register notice: FDA issues an order to reclassify medical image analyzers, including CADe devices, for mammography breast...

Purell Hand Sanitizers Unapproved New Drugs: FDA

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FDA warns Gojo Industries that its Purell Advanced Hand Sanitizer products are unapproved new drugs that dont meet requirements fo...

FDA Denies Persion Zohydro ER Petition

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FDA denies a Persion petition asking that it restrict ANDA approval for generic products citing Zohydro ER as the reference-listed...

15 Potential Signals of Risk, New Safety Info

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FDA releases a list of 15 potential drug safety signals that occurred in the fourth quarter of 2019.

Sarepta Again Works Appeals Magic to Win Approval

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Just-released approval documents shed light into how Sarepta was able to again win FDA approval for a Duchenne muscular dystrophy ...

Patient Service Inc. Settles Kickback Case for $3 Million

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The Justice Department says Patient Services Inc. is paying $3 million to resolve false claims allegations that it coordinated wit...

FDA Clears Teleflex Pacing Guidewire

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FDA clears a Teleflex 510(k) for the Wattson Temporary Pacing Guidewire, a bipolar device designed for use during transcatheter ao...