Becker's Hospital Review

FDA’s dense breast notification requirement explained

Effective Sept. 10, healthcare facilities providing breast imaging services will be required to notify patients of their breast density in mammography reports. Nina Vincoff, MD, division chief of ...
Healio

FDA grants 510(k) clearances to triage, notification findings on chest, head imaging

Please provide your email address to receive an email when new articles are posted on . The FDA has granted 510(k) clearances to seven triage and notification findings of varying conditions on chest X ...
JD Supra

FDA Releases Draft Guidance on New Dietary Ingredient Notification Procedures, Timelines

On March 5, 2024, the Food and Drug Administration (FDA) issued its “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry” (“Final Guidance”). The ...
JD Supra

FDA Issues Draft Guidance on Best Practices for Selecting Predicate Devices for 510(k) Notifications

The US Food and Drug Administration (FDA) has just issued a draft guidance entitled “Best Practices for Selecting a Predicate Device to Support a Premarket Notification 510(k) Notification.” This ...
Monthly Prescribing Reference

FDA Clears Apple’s Sleep Apnea Notification Feature

Apple’s Sleep Apnea Notification Feature is not intended to diagnose, treat, or aid in the management of sleep apnea. The Food and Drug Administration (FDA) has cleared the Sleep Apnea Notification ...
WFLA News Channel 8

Noveome Biotherapeutics, Inc. Receives FDA Notification to Proceed with its Phase 1-2 Clinical Trial in Treatment of NEC

PITTSBURGH, PA, UNITED STATES, December 11, 2023 /EINPresswire.com/ -- Noveome Biotherapeutics, Inc. Receives FDA Notification to Proceed with its Phase 1-2 Clinical ...
The National Law Review

FDA Releases Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements

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 ...
The National Law Review

New Draft Guidance on FDA Enforcement Discretion for Past-Due NDI Notifications

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 ...
MobiHealthNews

Apple receives FDA nod for hypertension notification feature

Apple has received clearance from the U.S. Food and Drug Administration (FDA) for its recently announced hypertension notification feature available on some of its smartwatches. The company unveiled ...
News Medical

FDA issues revised draft guidance to improve premarket safety notifications for new dietary ingredients

The U.S. Food and Drug Administration today issued a revised draft guidance to improve dietary supplement companies' new dietary ingredient (NDI) premarket safety notifications to the agency. These ...