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

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, ...

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 ...

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

Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent ...

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 ...

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 ...

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 ...

To provide additional transparency on the App Store, apps that are available in the European Union (EU)/European Economic Area (EEA), United Kingdom (UK), or United States (US), and that also meet ...