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The FDA has issued final orders classifying four medical devices as Class II (special controls), and said the classification will help increase patient access to the devices. Read More
In an effort to better understand high prices for drugs and diagnostics, prominent doctors groups and other advocacy groups have called on the Biden administration to openly share the costs of clinical trials paid for by the federal government. Read More
The FDA needs to work with the Federal Trade Commission (FTC) and other federal agencies to improve its regulation of at-home diagnostics, which are not clearly distinguished from relatively unregulated “general wellness products,” according to an opinion piece by three bioethicists in the Journal of the American Medical Association. Read More
The test offers accuracy “equivalent to next-generation sequencing, but with the simplicity of running on standard laboratory equipment,” said PathogenDx CEO Milan Patel. Read More
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