“NIVA HF is the culmination of our organization’s talent, intellect, passion, and hard work. “We are thrilled that FDA has recognized NIVA HF as a Breakthrough Device with important prospective clinical applications,” said Kyle Hocking, Ph.D., President & CEO of VoluMetrix. NIVA HF provides a non-invasive solution in heart failure care - taking this from hospital to home. Currently, this clinically important value can only be obtained through invasive catheterization of the heart and vasculature. The intended purpose of the NIVA HF device is to provide a proprietary NIVA Score that corresponds to a pulmonary capillary wedge pressure, or PCWP. As part of the Breakthrough Device program, FDA will work closely with VoluMetrix to advance pre-commercial development of NIVA HF and prioritize the review of subsequent regulatory submissions. Development of NIVA HF, which is being prepared for submission for De Novo regulatory clearance, is supported by a Fast-Track grant provided by the National Institutes of Health (NIH) and LaunchTN SBIR/STTR Matching Fund Program. VoluMetrix notes the NIVA HF is an investigational device designed to monitor the venous waveform, a novel physiologic signal, in heart failure patients, and represents the company’s flagship application for its Non-Invasive Venous waveform Analysis (NIVA) technology. VoluMetrix, a Nashville-based biotech startup dedicated to creating a new wave of solutions for vital monitoring to enhance well-being, today announced that its NIVA HF device has been designated as a Breakthrough Device by the U.S.
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