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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
AdvaMed again urged the federal government to emphasize devices as it tries to alleviate the semiconductor shortage caused by pandemic-induced supply chain problems. Read More
Applaud Medical’s Acoustic Enhancer is intended to treat calcium-based urinary kidney stones if they measure between 6 and 20 mm in diameter and are obstructing or deemed to present a significant risk of future obstruction. Read More
“This effort supports the president’s plan to deliver 500 million free at-home COVID-19 tests to the nation in response to the Omicron variant,” the Defense Department said in a statement. Read More
The device applies skin adhesive that provides a 14-day microbial barrier that allows patients to resume normal activities faster, including showering without special coverings or dressings. 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
The monitor can help identify patients who do or do not require ongoing treatment and can differentiate between allergic and nonallergic asthma, the company said. Read More