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

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 ...

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 ...

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 – ...

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.

Commercialization strategy in 2026 and beyond is more than a checklist. It requires a new mindset where cybersecurity is seen as a patient safety imperative, data is treated as a critical strategic ...

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 ...

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.

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, ...

Billions of dollars are lost annually in medical billing errors resulting from data entry mistakes, outdated coding practices, and duplicated charges.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 ...

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 ...

InVera Medical has received FDA 510(k) clearance for the InVera Infusion Device, a new minimally invasive device designed to help physicians deliver treatment more effectively to diseased leg veins, ...