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…
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…
An updated version of the Biosecure Act gives US businesses until 2032 to decouple from four Chinese biotech companies identified as being of “particular concern” over data mining on behalf…
Unclean assembly areas, incomplete repair data sheets, no documentation of service manager training and water damage with insects throughout the facility are but a sampling of observations in a Form…
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. Source: Drug Industry Daily
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. Source: Drug Industry Daily
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws…
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…
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…
The FDA’s recent Warning Letter to Augustine Temperature Management focused on a single — issue problems with medical device reporting (MDR) — citing the Bloomington, Minn.,-based company for multiple failures…