Tag: FDA
GE HealthCare announces the U.S. FDA 510(k) Clearance...
Former Employee of Medical Device Manufacturer Sentenced for Forging Two FDA Letters that Led to Illegal Sale of Medical Devices
The Justice Department announced that a federal...
FDA and CMS Statement: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They Are Made
The following is attributed to Jeff Shuren, M.D.,...
FDA Updates Cybersecurity Guidance for Medical Device Makers
The Food and Drug Administration Sept. 26 finalized guidance updating...
GE HealthCare Receives FDA Clearance for Portrait Mobile, A First-Of-Its-Kind, Wireless Monitoring Solution Aiding Early Detection of Patient Deterioration
GE HealthCare announced it has received 510(k) clearance...
Former Employee of Medical Device Manufacturer Pleads Guilty to Forging Two FDA Clearance Letters for Medical Devices
A Philadelphia-area man pleaded guilty for his role...
Illumina Cybersecurity Vulnerability Affecting the Universal Copy Service Software May Present Risks for Patient Results and Customer Networks: Letter to Healthcare Providers
The U.S. Food and Drug Administration (FDA) is informing...
Selling hearing aids over the counter could help millions of Americans
One company aims to shift views on the devices...
AirStrip ONE web client receives U.S. regulatory clearance
The U.S. Food and Drug Administration has issued...
Mobile health’s regulatory path
Dr. Anand K. Iyer, Chief Strategy Officer, WellDoc
For...
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