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Apple Watch is FDA's first-ever approved digital AFib history device - Apple Watch Discussions on...
AppleInsider· 21 hours agoThe FDA has approved the Apple Watch's atrial fibrillation history feature under its stringent...
FDA Qualifies Apple Watch's AFib History For Use In Clinical Studies - Slashdot
Slashdot· 4 hours agoIn a first for "digital health technology," the Apple Watch's atrial fibrillation (AFib) history feature has been approved by the FDA to join the FDA's ...
Apple Watch series AFib monitor getting FDA medical certification
Android Headlines· 9 hours agoThe Apple Watch series AFib feature has received new approval from the FDA. From now on, the results...
Opinion | The FDA Will Test You Now
The Wall Street Journal· 10 hours agoThe agency makes a power grab to regulate lab tests like medical devices.
FDA Issues Final Rule Regulating Many Laboratory-Developed Tests as Medical Devices
The National Law Review· 2 days agoOn April 29, 2024, the US Food and Drug Administration (FDA) issued the long-awaited final rule...
Palatin Announces FDA Clearance of IND Application for the Co-Administration of Bremelanotide with...
WKBN 27 Youngstown· 20 hours agoFood and Drug Administration (FDA) has completed its 30-day review of the investigational new drug (IND) application for the use of bremelanotide, a melanocortin receptor ...
JD Supra: Every Little One, Every Little One: FDA Issues a Warning Letter to a Medical Device...
JD Supra· 12 hours agoThis Bulletin summarizes the issues involved and our observations. FDA inspected the company and issued a Form FDA 483 List of Inspectional Observations ...
FDA, doctors warn about compounded Ozempic
WFTV via Yahoo News· 2 days agoIt’s a popular drug that millions of people are taking to lose weight, but the federal government and doctors are warning users about some versions of...
BrioHealth wins FDA nod to trial BrioVAD ventricular assist device
Clinical Trials Arena via Yahoo Finance· 21 hours agoBrioHealth Solutions has received investigational device exemption (IDE) approval from the US Food...
FDA Finally Moves to Scrutinize Specialized Health Screenings
ProPublica· 2 days ago“This is a significant step forward,” said Peter Lurie, president and executive director of the...