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ITGI Medical and Vascular Solutions plan to begin enrolling patients in a humanitarian device exemption trial of ITGI’s Aneugraft Dx coronary stent during the first quarter of next year. Read More
NeuroPace plans to launch its RNS Stimulator in the U.S. as soon as possible, following last week’s FDA approval of the novel anti-seizure device. Read More
Seattle-based Atossa Genetics has initiated a Class I recall of all lots of its Mammary Aspiration Specimen Cytology Test (MASCT) and the accompanying patient sample kit, along with the ForeCYTE Breast Health Test Kit, manufactured between Jan. 9 and Sept. 13, 2013. Read More
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A Thursday draft guidance from CDRH attempts to clarify the distinction between hearing aids and personal sound amplification products, or PSAPs.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