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…
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…
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,…
The FDA has joined forces with the Environmental Protection Agency (EPA) and the Department of Agriculture (USDA) on a plan to regulate genetically modified organisms and biotechnology products for humans.…
Concerns about unexpected shutdown leading to possible injury and/or death has caused the FDA to issue an alert about several cardiac devices manufactured by Getinge/Datascope/Maquet. Source: Drug Industry Daily