May 20, 2022
May 20, 2022
September 20, 2018
On Tuesday, September 11th, FDA granted two de novo classification requests for mobile medical applications to be used with the Apple Watch. ECG App The first app, referred to as the ECG app,...
November 24, 2015
In a recent interview with The Telegraph, Tim Cook, CEO of Apple®, discussed a variety of topics, including the Apple Watch and the production of a “government-licensed health product,” to name just...
July 25, 2016
FDA Revises Review Timeline Due to Increasing Number of Orphan Drug Applications: In 1983 Congress passed the Orphan Drug Act, which created FDA’s Orphan Drug Designation (ODD) program. The goal of...