Steven A. Farmer, MD, PhD, FACC, FASE, spoke on September 22 at "EU vs. US: Which Market Fits Your Device Strategy?", a NAMSA webinar comparing how medical device companies enter…

The New York Times reported this week that "The Trump administration is accelerating efforts to make artificial intelligence an integral part of medical care…

Something happened at graduation ceremonies this spring that should cause every health system CEO, hospital administrator, and digital health.…

The U.S. healthcare system has officially entered the era of artificial intelligence (AI). Organizations, practitioners, and patients are no longer merely trying on a new fad.…

FDA clearance is a necessary milestone for bringing a medical device to the U.S. market, but it is not the same as achieving market access…

Coverage of CMS's FY2027 inpatient payment rule suggests the agency repealed the shortcut that allowed FDA Breakthrough Devices to collect…

Initial discussion surrounding the proposed 2027 Physician Fee Schedule has largely centered on physician reimbursement and digital health…

Everyone analyzing the proposed 2027 Physician Fee Schedule is focused on physicians and digital health companies. A reasonable instinct,…

On July 14, CMS released its proposed 2027 Physician Fee Schedule, the annual rule that determines how Medicare pays physicians…

Last week in London, I attended the R&D Partners MedTech Founders Summit. Two panels, one evening and a lot of honesty…

Ambient clinical intelligence (ACI) is gaining traction in healthcare for one simple reason: it addresses a problem clinicians wrestle with every…

Healthcare has moved past the stage where generative AI can win attention on novelty alone. The market is still crowded with demos, pilots…

For decades, U.S. Food and Drug Administration (FDA) approval was treated as the defining milestone for medical devices and digital…

There is a special kind of irritation that hits when your phone buzzes and you think, just for a moment, that someone needs you. Maybe…

For decades, the United States has been the undisputed global leader in healthcare research and innovation. Our academic medical…

The U.S. Food and Drug Administration (FDA) regulates the more than 175,000 medical devices that are on the U.S. market today. To enhance the transparency, efficiency, and agility of the agency’s oversight, FDA’s Total Product Life Cycle (TPLC)…

The term “totality of evidence” refers to the concept that all available information and evidence related to a particular matter should be considered. A single, or even a few pieces of evidence are not enough…

When it comes to healthcare innovation — new treatments and products that could improve lives, or even lengthen and save them — we often group pharmaceutical developments…

Real-World Data (RWD) studies are gaining momentum in the medical device market, backed by the FDA, CMS, and growing industry adoption…

Getting a startup off the ground is tough, but scaling it? That’s where things start to break. Early traction proves demand…