This week, a company pares down those giant robotic surgery systems, a drug-coated angioplasty balloon opens coronary arteries with pressure and medication, an ablation system eases the pain of metastatic…

GE HealthCare subsidiary, Datex-Ohmeda’s recall of EVair and Jun-air compressors has been deemed Class I by the FDA due to potentially elevated levels of formaldehyde emissions. Source: Drug Industry Daily

During the second session of the 118th Congress, FDAnews will track pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations…

The FDA’s Medical Imaging Drug Advisory Committee (MIDAC) meets Tuesday to tackle concerns about Lumisight, a device-injection combo product from Lumicell designed to help clinicians detect residual breast cancer following…

The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with…

When it comes to integrating artificial intelligence into healthcare networks, stakeholder enthusiasm appears to be outstripping FDA oversight, according to a survey by the Berkeley Research Group. Source: Drug Industry…

This edition of Quick Notes looks at the FDA alerts and letters regarding artificial ankle failures, operating tables moving unexpectedly and unlatched incubator panels. Source: Drug Industry Daily

Over the past week, the FDA issued a final guidance on reporting the amount of listed drugs and biological products. Source: Drug Industry Daily

Bankrupt Endo Health Solutions (EHSI) has agreed to plead guilty and pay just over $2 billion to resolve criminal and civil investigations, as well as its bankruptcy debt, related to…

The U.S. government should have to prove that the claims in False Claims Act (FCA) kickback cases would not have been submitted “but for” kickbacks, says Teva Pharmaceuticals in response…