FDA and CMS each play a critical role in getting new medical devices to patients, and they work most effectively when aligned ...

Having already set expectations around the structured capture of medical device safety data, regulators are now ready to analyze related insights, and they expect device manufacturers to match this ...

As generative AI becomes embedded in clinical research, concerns around hallucinated citations and unverified outputs are ...

Stryker signs definitive agreement to acquire Amplitude Vascular Systems to add next-generation IVL technology to peripheral ...

Traditionally, contract negotiation has been viewed as a financial or legal responsibility, typically led by finance teams, ...

Companies and researchers often fail to disclose negative trial results, resulting in significant gaps in the public record ...

InVera Medical has received FDA 510(k) clearance for the InVera Infusion Device, a new minimally invasive device designed to help physicians deliver treatment more effectively to diseased leg veins, ...

The FDA has approved the NEXUS Aortic Arch Stent Graft enabling commercial launch of the NEXUS System in the US. Endospan announced that the U.S. Food and Drug Administration (FDA) has approved the ...

Allevion Medical announced the FDA 510(k) clearance of Vantage, a fully disposable, sterile system designed to simplify and enhance minimally invasive lumbar decompression procedures associated with ...

Serenity Medical announced FDA Humanitarian Device Exemption (HDE) approval for its novel River stent. The River stent is for the treatment of severe idiopathic intracranial hypertension (IIH) in ...

In this part 2 of a 4-part series, Melissa highlight how the moment AI begins to influence decisions or workflows, it is operating within a regulated environment. Aligning with documentation standards ...