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

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 ...

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 ...

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

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

The MedTech industry has seen significant growth and raised expectations as it adapts to evolving healthcare needs in the wake of the COVID-19 pandemic. The industry’s ability to make technology a ...

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 ...

The deeper insights provided by a single source of truth help regulatory teams pinpoint and address gaps in data collection during each trial phase. By mitigating potential risks earlier in the ...

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

Geography is effectively determining whether patients receive timely cardiac diagnosis, or even any diagnosis at all. In an effort to address the problem, cardiologists and health systems are ...