LifeVac receives FDA De Novo classification for anti-choking device

LifeVac has received De Novo classification from the US Food and Drug Administration (FDA) for its suction anti-choking device under 21 Code of Federal Regulations (CFR) 874.5400.

LifeVac Becomes the First and Only FDA-Authorized Anti-Choking Device

LifeVac LLC announced today that the U.S. Food and Drug Administration (FDA) has granted De Novo classification for LifeVac under 21 CFR 874.5400, formally establishing the device type "suction ...
STAT

FDA grants ‘breakthrough’ status to generative AI chatbot for surgical patients

The FDA's decision on a chatbot for patients recovering from surgery could offer clues on how the agency plans to regulate ...

Cognita secures FDA breakthrough device designation for CXR

Mosaic expects the collaboration with the FDA will help address diagnostic capacity constraints in the US healthcare system.
JD Supra

Navigating Medical Device Regulation and IP Protection in the United States (Part 2 of 2)

In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and ...
MD&M East

FDA Challenges in 2025: How Medical Device Companies Can Navigate Agency Changes

As 2025 draws to a close, the state of the federal system of regulatory affairs in the United States continues to operate in a somewhat chaotic fashion. FDA has perhaps been most affected by changes ...
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 ...
Hosted on MSN

FDA scraps ‘Final Rule’ classifying LDTs as medical devices

The US Food and Drug Administration (FDA) has chosen to axe its ‘Final Rule’ from May 2024, bringing to an end a long-running agency-industry dispute around the proposed classification of ...
Fierce Biotech

FDA slams ExThera with warning letter over controversial blood filter device

The FDA slammed ExThera with a warning letter for deviating from the regulatory agency’s guidelines by promoting and selling ...
MD&M East

FDA Staff Cuts & Global Tariffs Pose Challenges for Medical Device Development, Experts Warn

During an April 7 session of the Biopharma Congress, Janet Woodcock, MD, former acting FDA Commissioner and former principal deputy commissioner of food and drugs, called the recent FDA staff cuts a ...
MobiHealthNews

How to avoid FDA mHealth regulation

(I would like to thank Leah Kendall of EpsteinBeckerGreen and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s and should not be ...