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BioControl Medical Makes Progress Toward FDA Review for CardioFit Heart Stim Device

Tue, 03/26/2013 - 1:27pm
Mass Device

The FDA approves the 3rd and largest phase of BioControl Medical's investigational device exemption trial of the CardioFit vagal nerve stimulation device.

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Israel and Minnesota-based BioControl Medical won FDA approval to proceed with the 3rd and largest phase of its INOVATE-HF trail, evaluating its CardioFit vagal nerve stimulation system in treatment of heart failure.

The global, multi-center trial aims to provide clinical data in support of BioControl's premarket approval application for FDA clearance of the CardioFit system, according to a press release.

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