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Better communication between CDRH and the Center for Drug Evaluation and Research should translate to fewer requests for duplicate data on companion diagnostic submissions. Read More
A Thursday draft guidance from CDRH attempts to clarify the distinction between hearing aids and personal sound amplification products, or PSAPs.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