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de novo clearance
MedTech
FDA clears Pi-Cardia's leaflet splitter for valve-in-valve TAVR
Pi-Cardia’s ShortCut device received a de novo clearance to open up old heart valve implants and clear the blood flow into the coronary arteries.
Conor Hale
Oct 1, 2024 2:00pm
FDA clears its first at-home blood test for syphilis
Aug 16, 2024 1:56pm
FDA clears hydrogel nerve cap for blocking amputee phantom pains
Jul 22, 2024 10:07am
FDA clears its first fingerstick hepatitis C diagnostic test
Jul 2, 2024 11:04am
FDA hands de novo clearance to Scopio's bone marrow pathology AI
Apr 17, 2024 12:56pm
FDA confers clearances to 2 novel antibacterial implant coatings
Apr 15, 2024 2:07pm