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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
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 of the Chinese government. Read More
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 483 the FDA levied on medical device manufacturer Allied Medical of St. Louis. 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
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 and regulations that could impact your business. 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
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 to adequately develop, maintain and implement written MDR procedures. Read More
This week, the FDA announced its final rule for laboratory developed tests. Draft guidances were published on enforcement policies for tests during a Section 564 declared emergency, IVD enforcement policy in the absence of a Section 564 emergency declaration and a REMS logic model. Advisory committee meetings were announced for Donanemab, Lilly’s Alzheimer’s drug and for Midomafetamine capsules. Read More
The Department of Justice (DOJ) has formed a new enforcement arm — the Task Force Health Care Monopolies and Collusion (HCMC) — to guide the department’s policy approach for healthcare, but also to pursue investigations as well as civil and criminal enforcement in healthcare. Read More