FDA says it has granted breakthrough device designation to 1,041 devices from 2015 through the 9/30 end of the 2024 fiscal year.
FDA approves PTC Therapeutics Kibilidi as the first gene therapy to treat aromatic L-amino acid decarboxylase deficiency.
FDA grants a de novo marketing authorization to Omron Healthcare for its new home blood pressure monitors featuring AI-powered atrial fibrillation det...
The Sedgwick third quarter 2024 recall index documents an increase in medical device recalls and a decrease in drug recalls.
FDA grants SonoMotion a de novo marketing authorization for its Stone Clear device for the ultrasound treatment of post-lithotripsy kidney stone fragm...
FDA cautions Merz over misleading representations about its Xeomin in a promotional piece featuring celebrity spokesman Nate Berkus.
Philips Respironics recalls (Class 1) its Garbin Evo ventilators due to the potential for aerosol deposit accumulation on the devices internal flow se...
Two stakeholder trade associations suggest changes to an FDA strategy document on innovative manufacturing technologies.
