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Corvia Medical’s Corvia atrial shunt did not improve rates of cardiovascular death or non-fatal ischemic stroke after 12 months, or the rate of total heart failure events up to 24 months, in a late-stage trial reported in The Lancet. Read More
The FDA has designated BioCardia’s CardiAMP Cell Therapy System for heart failure a breakthrough device, making it the first combination cardiac cell therapy and device to receive this status. Read More
The Center for Devices and Radiological Health (CDRH) has set aggressive goals to measure its success over the next few years in a “strategic priorities” report released yesterday. Read More
Becton Dickinson (BD) has completed its purchase of Cytognos, a privately held Spanish company that specializes in flow cytometry products for blood cancers. Read More
Senators and members of the House of Representatives from both political parties have asked the FDA to explain the holdup in submitting the commitment letter that the agency negotiates with the industry ahead of reauthorization of the Medical Device User Fee Act (MDUFA). Read More
A properly designed and executed audit program holds the key to preventing most, if not all, of the leading 483 observations related to quality control unit issues. Read More