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…