We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
If CDRH doesn't get $11.5 million from Congress this year to keep up its program to prevent medical device supply chain disruptions, the program will go dark next year, said center director Jeff Shuren on Tuesday during an Alliance for a Stronger FDA webinar focused on the budget. Read More
The 2023 annual survey of members of Team NB, The European Association Medical Devices — Notified Bodies, shows a steady increase in both applications and certificates issued by association members, as well as an increase in number of notified bodies. Read More
Adding a chapter to the prolonged, back-and-forth legal battle involving recalled continuous positive air pressure (CPAP) machines, Philips Respironics filed a complaint in a Pennsylvania federal court Friday insisting SoClean — manufacturer of ozone-based cleaning systems for breathing devices — pay part of a $1.1 billion settlement Philips reached last month with consumers who claimed they were injured by the devices. Read More
Cue Health must immediately stop sale and distribution of its COVID-19 tests and consumers should throw away any of the tests they may still have, the FDA says, following an inspection of the company’s San Diego facility last fall. Read More
Philips Respironics has recalled all Trilogy Evo ventilators that are not on the latest software update (1.05.06.00) due a software issue that can result in a sudden loss of ventilation while the device alarms. Read More
The company had not established internal systems that result in timely and effective evaluation of events that may be subject to MDR requirements. Read More
Route 92 Medical is recalling medical products containing its Tenzing 7 delivery catheters due to multiple instances of distal tip separation at the proximal marker band. Read More
Reports of patient burn injuries have prompted Megadyne Medical Products to institute a global discontinuation and voluntary recall of its Mega Soft Pediatric Patient Return Electrodes. Read More
This edition of Quick Notes reviews the FDA’s 510(k) clearance of Outset Medical’s TabloCart as well as perfusion imaging analysis by RapidAI and an OTC version of the Masimo Stork baby monitor. FDA approval was granted to Genescopy’s ColoSense. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) continued its proactive approach to regulating standalone AI medical devices (AIaMD) with Thursday’s launch of its AI Airlock sandbox model, allowing MHRA to test a range of regulatory issues for the devices used within the country’s National Health Service. Read More