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Ionocare has received 510(k) marketing clearance from the FDA to remanufacture and market a used DaVinci robotic surgical system attachment — 8 mm monopolar curved scissors for the EndoWrist Si system. Read More
The FDA has granted Grifols marketing clearance for its AlphaID At Home direct-to-consumer screening test for alpha-1 antitrypsin deficiency, which can cause a hereditary form of emphysyma as well as cirrhosis of the liver. Read More
Nuheara has gained FDA clearance for its HP Hearing Pro, meeting both FDA Class II and OTC requirements for hearing aids in a wireless ear bud design. Read More
Massachusetts-based Abiomed’s Impella RP Flex with SmartAssist heart pump has received FDA’s premarket approval to provide temporary right ventricular support for up to 14 days. Read More