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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
The top clinical areas to receive the breakthrough designation have been cardiovascular, neurology, orthopedic, gastroenterology and urology. Read More