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

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 ...

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

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

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 ...

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

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

Allevion Medical Receives FDA Clearance for Vantage™, Introducing a Fully Disposable Approach to Minimally Invasive Spinal ...

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

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 ...

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 ...