The latest medical news on Clinical Researcher

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FDA Daily Update

The Department of Justice (DOJ) has formed a new enforcement arm — the Task Force Health Care Monopolies and Collusion (HCMC) — to guide the depart...

FDA Daily Update

This week, the FDA announced its final rule for laboratory developed tests. Draft guidances were published on enforcement policies for tests during...

FDA Daily Update

The FDA’s recent Warning Letter to Augustine Temperature Management focused on a single — issue problems with medical device reporting (MDR) — citi...

FDA Daily Update

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) continued its proactive approach to regulating standalone AI medical devices (A...

FDA Daily Update

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 a...

FDA Daily Update

Concerns about unexpected shutdown leading to possible injury and/or death has caused the FDA to issue an alert about several cardiac devices manuf...

FDA Daily Update

The FDA has joined forces with the Environmental Protection Agency (EPA) and the Department of Agriculture (USDA) on a plan to regulate genetically...

FDA Daily Update

Clarity on the definition of “remanufacturing” for reusable medical devices needing maintenance or repair is the focus of a final guidance the FDA ...

FDA Daily Update

A mobile app that controls an insulin pump has been recalled for a software problem that potentially leads to crash of the app and pump battery dep...

Clinical Trial Results

NRx Pharmaceuticals, Inc. (Nasdaq NRXP) ( NRx Pharmaceuticals , the Company ), a clinical stage pharmaceutical company, today announced a statistic...

Clinical Trial Results

Bayer will present detailed results from the pivotal Phase III studies OASIS 1 and 2 evaluating the efficacy and safety of the investigational comp...

FDA Daily Update

A major agency-wide reorganization affecting regulatory affairs and medical products, and more than $12 million to tackle supply chain issues acros...