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

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

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 ...

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.

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

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

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 ...

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

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 ...