The Draeger SafeStar 55 has been identified by the U.S. FDA as a Class I recall, the most serious type of recall.
Pear Therapeutics received STeP for Medical Devices designation from the FDA for a product candidate aimed to treat acute and chronic pain.Read More
The U.S. FDA’s draft cybersecurity guidance highlights the significant impact cybersecurity incidents have had on medical networks globally.Read More
The FDA is holding a meeting to discuss the reauthorization of the Medical Device User Fee Amendments for fiscal years 2023 through 2027.Read More
The U.S. FDA is updating the April 2020 Safety Communication to provide new information supporting the transition to fully disposable duodenoscopes and those with disposable components.Read More
Medtronic is recalling a catheter product following uncertainty regarding whether packing for the item was sterile.Read More