PhysioWave Receives FDA Clearance for Breakthrough Innovation

PhysioWave, Inc, a developer of cardiovascular risk assessment biomarkers and Stanford University spin-out, announced today that the company has received FDA clearance for its PhysioWave Pro™ cardiovascular analyzer.

This breakthrough device, many years in development, allows easy and quick measurement of an important new vital sign, pulse wave velocity (PWV). With Nokia’s recent withdrawal of the non-FDA-cleared PWV feature of its Body Cardio consumer scale, PhysioWave now has the only scale-based PWV device on the market, backed by an extensive patent portfolio.

“We are thrilled to be bringing this new technology to clinical practices worldwide and look forward to partnering to develop a lower-cost version for consumers,” said Greg Kovacs, PhysioWave’s founder and acting CEO, who has led the company for more than a year leading up to clearance. “This measurement provides real, actionable information on cardiovascular health to everyone, and can work in concert with all manner of wearables and health apps. We believe we are at the beginning of a highly significant development in medicine.”

PWV is a measurement of the stiffness of the blood vessels transporting blood from the heart to the body. Increased stiffness, associated with increased cardiovascular risks (e.g., coronary heart disease, stroke, hypertension), causes the blood pulses to travel faster, resulting in a higher measured PWV. Previously difficult to measure, PWV can now be measured simply by standing on the PhysioWave Pro™ device for less than a minute. The device, similar to a body weight scale, also measures pulse rate, weight and BMI.

Early deliveries to clinical customers are planned for later in 2018.

To learn more about PhysioWave, click here.

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