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

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 – ...

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 ...

Orthogonal worked with Brian Binkowski, to gain a clearer picture of the state of SaMD approvals in the U.S. Following is what they learned about the rate of FDA approvals and clearances and which ...

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 ...

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.

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.

The Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced an expedited pathway for Device Makers to potentially expedite access to certain ...

Medtronic announced several regulatory milestones for its Hugo robotic-assisted surgery platform, including FDA submissions for general and gynecologic surgery indications and the LigaSure™ RAS ...

Billions of dollars are lost annually in medical billing errors resulting from data entry mistakes, outdated coding practices, and duplicated charges. Artificial Intelligence (AI) and Machine Learning ...

A recent project conducted by Northeastern graduate students looked at device recalls over the past five years and some of the common threads. In 2018, the top causes of recalls were software, ...