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 ...

A comprehensive update on the combination products market shows significant industry partnerships, development challenges, and strategic imperatives for success in the sector characterized by dynamic ...

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 ...

Simple Consult, LLC, a Delaware-based digital healthcare provider, announced the launch of its virtual consultation platform. With each visit priced at a flat fee of $29 and no insurance required, the ...

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 ...

As these regulations continue to change, MedTech companies need to leverage the right systems to streamline processes, ensure continuous compliance, and mitigate the risks associated with ...

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 ...

FDA will decrease its workforce by approximately 3,500 full-time employees, with a focus on streamlining operations and centralizing administrative functions. This reduction will not affect drug, ...

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 ...