GlobalData on MSN

Bayesian Health secures first FDA clearance for AI-driven continuous sepsis monitor

The device is the first of its kind to get the FDA greenlight to allow for early sepsis detection.
JD Supra

FDA medical device inspections in 2025: What we're seeing, what we expected, and why you need the right expertise now

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

Cybersecurity Top Reason The FDA Rejects Medical Device Submissions, Says Blue Goat Cyber’s Christian Espinosa

FDA premarket rejections have surged since the February 2026 cybersecurity guidance. Espinosa speaks at MedTech World ...
JD Supra

CMS and FDA Announce New RAPID Program for Medicare Coverage of Breakthrough Medical Devices

On April 23, 2026, the Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) jointly announced the ...
HealthLeaders Media

FDA relaxes rules for wearable health devices

The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...
The National Law Review

FDA Issues Draft Guidance on Cybersecurity for Medical Devices

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
Medical Xpress

As FDA slashes workforce, number of new medical devices reaching the public has fallen

U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low for the January to March period, as sources say recent layoffs have had ...

Food and Drug Administration (FDA): What It Is and Does

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
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FDA and CMS launch RAPID pathway to speed Medicare device coverage

What is RAPID?: A new FDA-CMS program to align review processes and speed Medicare coverage for breakthrough devices to within 60–90 days of FDA authorization. Why it matters: Faster coverage could ...
Healthline

Which Products Does the FDA Regulate?

The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...
National Academies of Sciences%2c Engineering%2c and Medicine

Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years

As noted in Chapter 1, the committee was charged by the Food and Drug Administration (FDA) to review the 510(k) clearance process and answer two principal questions: Does the current 510(k) clearance ...