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New FDA draft guidance on blood glucose test systems, released in January, shouldn’t lengthen approval times, a CDRH official assured devicemakers Wednesday during a webinar hosted by the American Association for Clinical Chemistry. Read More
When applying CLIA categorization of diagnostics, CDRH plans to alert sponsors to the categorization within two weeks of a positive marketing decision, the agency says. Read More
Wright Medical’s Augment Bone Graft is once more on the road to FDA approval, following the agency’s agreement to accept a further PMA amendment on the product. Read More
Boston Scientific’s Rebel Platinum Chromium Coronary Stent System has gained CE Mark approval for patients with coronary artery disease, the devicemaker said Wednesday. Read More