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 present.
“We are thrilled that FDA has recognized NIVA HF as a breakthrough device with important prospective clinical applications,” VoluMetrix president & CEO Kyle Hocking said in the release. “NIVA HF is the culmination of our organization’s talent, intellect, passion, and hard work. It represents the first of many potential vehicles for our NIVA vital monitoring technology, and we look forward to working closely with regulators to expedite its development and regulatory review.
“Ultimately, our mission is to improve the care experience for as many heart failure patients as possible, as quickly as possible. This designation is a powerful milestone in that journey, and we are grateful for it.”