August Is Hot with New FDA Breakthrough Device Designations

August Is Hot with New FDA Breakthrough Device Designations

Interatrial Shunt for heart failure

Caesarea, Israel-based V-Wave has received breakthrough device designation for its Interatrial Shunt for heart failure. It is one of several companies this month to receive the designation, which is granted to devices that have the potential to offer a more effective treatment or diagnosis of…

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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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