Some manufacturers are now embedding CER processes within broader regulatory operating systems, integrating authoring, ...

Originally CE marked in 2021 for limited to high-risk patients only, .Abbott has now received CE mark approval for its Navitor transcatheter aortic valve replacement (TAVR) system to treat low- and ...

A new EU Commission study on the Deployment of AI in Healthcare makes one thing crystal clear: AI isn’t just a buzzword, it could be the lifeline our systems desperately need. I’m a startup advisor ...

Having enjoyed tremendous success and growth in value-based care models, I am passionate about helping other primary care practices thrive in the shifting healthcare climate. I help healthcare ...

Inspira Technologies has received U.S. Patent approval for its ART500 device. The patent is for low flow rates extracorporeal oxygenation system and methods of use and represents the core technology ...

Episodic fatigue isn’t just about long agendas or IT timelines—it’s about spending decades refining a system built for care events, while health outcomes demand a system built for people’s lives.

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 ...

Increasing patient demand, barriers to access, and elevated costs are pushing healthcare providers to reconsider traditional clinical and operational workflows to meet growing challenges and improve ...

The Problem: A Rigid, Risk-Prone Development Model The industry’s heavy reliance on waterfall project management has resulted in long, siloed, and high-risk product development cycles. This model does ...

As healthcare pushes forward in digital transformation, AI has emerged as a critical tool in optimizing electronic medical records. EMRs remain both vital and frustrating. Clinicians wrestle with ...

Titanium has become a vital material in modern medicine due to its strength, light weight, corrosion resistance, and exceptional biocompatibility with high long-term success rates and minimal risk of ...

Evolving regulations and market requirements have kept medtech companies on their toes for years. EU MDR, for example, has been a top priority and now, more companies are moving toward EU MDR ...