The FDA’s AI Chabot, Elsa, is Failing
Mark Hait, Contributing Editor
The Food and...
Tag: FDA
First FDA-Approved Robot-Assisted Microsurgery for Head and Neck Cancer Performed at Cedars-Sinai
Cedars-Sinai has successfully performed the...
GE HealthCare Unveils Enhanced Voluson Expert Series Women’s Health Ultrasound Systems with Focus on Early Detection and Exam Efficiency
GE HealthCare announced it has received 510(k)...
Cybersecurity Vulnerabilities with Certain Patient Monitors from Contec and Epsimed: FDA Safety Communication
The U.S. Food and Drug Administration (FDA) is...
GE HealthCare Announces the FDA Clearance of nCommand Lite by IONIC Health
GE HealthCare announces the U.S. FDA 510(k)...
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,...
FDA Updates Cybersecurity Guidance for Medical Device Makers
The Food and Drug Administration Sept. 26...
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)...
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...