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.
A Thursday draft guidance from CDRH attempts to clarify the distinction between hearing aids and personal sound amplification products, or PSAPs. Read More
San Luis Obispo, Calif.-based FzioMed said the FDA has agreed to hear its appeal on a decision not to approve the company’s Oxiplex Gel spinal product, a clear, absorbable gel applied during lumbar spine surgery. Read More
The FDA’s Ear, Nose and Throat Devices Panel voted Friday to recommend approval of a first-of-its kind cochlear implant that does not destroy a patient’s residual hearing. Read More
Medtronic expects smooth sailing for its CoreValve transcatheter aortic valve PMA, after the FDA took the rare step of saying clinical trial data on extreme-risk patients is so compelling that an advisory panel meeting won’t be needed. Read More