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, ...

The FDA has approved the NEXUS Aortic Arch Stent Graft enabling commercial launch of the NEXUS System in the US.

InVera Medical has received FDA 510 (k) clearance for the InVera Infusion Device, a new minimally invasive device designed to ...

E. Almeida as Chief Executive Officer, effective immediately upon closing of the previously announced company acquisition.

Designed to expand treatment options for patients with cirrhosis and complications of portal hypertension, 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 ...

As organizations introduce additional technologies, including AI-enabled tools and CRM platforms, these gaps become more ...