VoluMetrix’s venous waveform monitor wins FDA breakthrough designation

[Image from VoluMetrix]VoluMetrix announced today that it received FDA breakthrough device designation for its NIVA HF venous waveform monitor.

Nashville, Tenn.–based VoluMetrix designed the investigational NIVA HF device to monitor the venous waveform, a novel physiologic signal in heart failure patients, through its non-invasive venous waveform analysis (NIVA) technology.

According to a news release, a fast-track grant from the National Institutes of Health (NIH) supports the development of NIVA HF, which is currently being prepared for FDA de novo regulatory clearance.

NIVA technology represents a way to optimize hemodynamic assessment through signal capture with a non-invasive wrist sensor, signal deconstruction and signal decoding, VoluMetrix said. NIVA HF provides a proprietary NIVA score that corresponds to a pulmonary capillary wedge pressure (PCWP), a value that can only be obtained through invasive catheterization of the heart and vasculature at p…

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