By the time most medtech organizations noticed their teams were using AI in regulatory work, the governance conversation was ...

CMS’s proposed expansion of Medicare TAVR coverage to include select asymptomatic severe aortic stenosis patients and reduce ...

Artivion has finalized its acquisition of Endospan Ltd., adding the FDA-approved NEXUS Aortic Arch System to its portfolio of aortic arch therapies. The deal strengthens the company’s position in 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 ...

A persistent tension exists between the drive for rapid technological advancement, the mandate for government oversight, and the paramount importance of patient safety. It is a foundation for the U.S.

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 ...

Market Access is now the central input into M&A and value-driven divestitures, enabling MedTech leaders to reshape portfolios for strategic advantage, long-term growth, and greater value to patients – ...

It looks at the rise of fraudulent research and scientists in the life sciences industry, the reasons for the rise, and suggests some measures that companies can take to counter this growing threat to ...

Strategic Evaluation Criteria (Weighted) Once the threshold criteria are satisfied, the following factors can be analyzed and weighed according to the specific context of the technology and the ...

Medtronic is overhauling its cardiovascular business in a major restructuring that includes new operating divisions, ongoing acquisitions, and a strategic push into higher-growth cardiac technologies.

The agency launched Elsa 4.0, an upgrade to the agency’s internal AI tool available to all FDA staff, from scientific reviewers to investigators. The U.S. Food and Drug Administration today announced ...

New set of 73 Real World Evidence examples illustrate how RWD can support rigorous validation of novel device software functions across multiple disease areas. By: Daniel Caños, Ph.D., MPH, Director, ...