VoluMetrix’s Niva-HF Granted Breakthrough Device Designation

June 15, 2021—VoluMetrix announced that its Niva-HF device has been granted Breakthrough Device designation by FDA. Niva-HF is an investigational device designed to monitor the venous waveform in heart failure patients. VoluMetrix is a biotech startup company based in Nashville, Tennessee.

The company stated that the device is the flagship application for its noninvasive venous waveform analysis (NIVA) technology. The venous waveform is an energy-based signal generated by the heart and respiratory activity that reflects numerous physiologic conditions, including pulse rate and respiration, as well as intravascular and extravascular dynamics.

NIVA was developed to optimize hemodynamic assessment in the following three key ways: signal capture (using a noninvasive wrist sensor), signal deconstruction (mapping individual amplitudes within a patient’s waveform), and signal decoding.

According to the company, the intended purpose of the Niva-HF device is to provide a NIVA Score that corresponds to a pulmonary capillary wedge pressure. Currently, this value can only be obtained through invasive catheterization of the heart and vasculature. The Niva-HF device provides a noninvasive solution in heart failure care.

As part of the Breakthrough Device program, FDA will work closely with VoluMetrix to advance precommercial development of Niva-HF and prioritize the review of subsequent regulatory submissions.

VoluMetrix is preparing Niva-HF for submission for FDA de novo regulatory clearance. The device is supported by a Fast-Track grant provided by the National Institutes of Health and Tennessee’s LaunchTN SBIR/STTR Matching Fund Program.