Noninvasive venous waveform monitoring device receives FDA breakthrough device designation
Click Here to Manage Email Alerts
VoluMetrix, a biotech startup focused on vital monitoring, announced the FDA granted its venous waveform monitoring device a breakthrough device designation.
According to a press release, the monitoring device (NIVAHF) is a noninvasive method of monitoring the venous waveform in patients with HF.
Venous waveform is an energy-based signal that reflects physiologic conditions, including pulse rate, respiration and intravascular and extravascular dynamics, according to the release.
The device is designed to improve hemodynamic assessment via optimized signal capture using a noninvasive wrist sensor; signal deconstruction by mapping individual amplitudes within a patient's waveform; and signal decoding, the company stated in the release.
According to the release, the device will provide a proprietary “NIVA Score,” corresponding to pulmonary capillary wedge pressure. Currently, this value can only be obtained through invasive catheterization of the heart and vasculature.
Collapse
Click Here to Manage Email Alerts