We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
In a bid to cut down on orphan medical device developers wasting agency time, the FDA is outlining new, detailed guidelines for what constitutes a legitimate topic for formal and informal presubmission meetings. Read More
European regulators have granted Edwards Lifesciences’ next-generation Intuity Elite valve system CE Mark approval, the Irvine, Calif., devicemaker said Friday. Read More
The FDA has finalized a guidance on interactive reviews to include commitments it made in the MDUFA III commitment letter and to expand use of the process. Read More
“Accurate detection … is critically important in efforts to successfully detect and potentially reduce the incidence of cervical cancer,” Cepheid CEO John Bishop says. Read More
The FDA last month approved St. Jude Medical’s Allure Quadra Cardiac Resynchronization Therapy Pacemaker (CRT-P), Assurity pacemaker and Endurity pacemaker families of devices. Read More