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

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 ...

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 – ...

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 ...

Billions of dollars are lost annually in medical billing errors resulting from data entry mistakes, outdated coding practices, and duplicated charges.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

As of October 2023, the FDA had identified 692 artificial intelligence/machine learning- enabled products that received clearance for marketing, with sustained growth projected for both submission ...

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.

To avoid delays in timelines, companies should develop IFU cleaning instructions with the worst-case clinical use and contamination method in mind. The FDA and International Organization for ...

Noah Labs Vox,™ a voice-based algorithm that detects worsening heart failure weeks before hospitalization, has received US Food and Drug Administration (FDA) Breakthrough Device Designation (BDD).