FDA clears Abiomed’s Breethe lung life support system, enabling use in COVID-19

FDA clears Abiomed’s Breethe lung life support system, enabling use in COVID-19

As the number of daily coronavirus cases in the U.S. once again begins to climb to new records, the FDA granted a 510(k) clearance to Abiomed’s compact, all-in-one life support system for bypassing a patient’s struggling heart and lungs.

Sourced through Scoop.it from: www.fiercebiotech.com

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Omnica Corporation is a privately-held design, engineering, and medical product development firm located in Irvine, California. The 28-person company is staffed with full-time employees and has been in operation since 1984. Our speciality is custom product development for the medical industry and industrial fields.

Our expertise is developing complex medical devices.Technical personnel at Omnica includes designers, mechanical engineers, electronic and software engineers, advanced R&D specialists, regulatory staff (for FDA documentation), machinists and model makers.

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