Posts Tagged ‘aaps’

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 and regulations that could impact your business. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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…

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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