Corvia Medical Inc. is enrolling patients in a 100-site multinational study of its Interatrial Shunt Device that will measure traditional heart failure endpoints as well as biosensor data transmitted to the cloud for analysis by Napier, Ill.-based Physiq's artificial intelligence analytics. The trial will evaluate Tewksbury, Mass.-based Corvia's device in heart failure with preserved and mid-range ejection fraction.
BOSTON – The FDA's Center for Device and Radiological Health (CDRH) released draft guidance on Monday aimed at encouraging the use of patient input in medical device clinical trials and helping sponsors understand how they can use patient engagement to improve the design and conduct of investigations.
There have been three oncology drug approvals by the U.S. FDA over the last few years that were based solely on a genetic biomarker, rather than the location in the body where the tumor originated. But to make this tissue-agnostic approach a reality for oncology patients, detecting those genetic biomarkers will have to become increasingly easy and standardized.
The recent progress in interventional cardiology has largely been driven by the aortic valve, although calcification of the aortic root has proven a difficult hurdle to overcome. A newly published study demonstrates that the Tendyne device by Abbott Vascular Inc., of Santa Clara, Calif., can be readily used not just to treat failing mitral valves, but works well in these patients with severe calcification, an achievement that could quickly vault the transcatheter approach past conventional surgical approaches in this population.