PhysioWave's pulse wave velocity feature gets the all-clear from FDA

By Laura Lovett
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Correction: A previous version of this story misstated that PhysioWave connects to the user's smartphone. It has been updated to state the system uses a dedicated tablet interface. 

University of Stanford spin-out has just received FDA clearance for its pulse wave velocity (PWV) cardiovascular analyzer scale, which measures the stiffness of the vessels transporting blood from the heart to the body. The new technology will come in the form of a scale. 

“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 customers,” Greg Kovacs, PhysioWave’s founder and CEO, said in a statement. “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.”

The new scale, called the PhysioWave Pro, also measures pulse rate, weight, and BMI, and according to the website uses a dedicated tablet as user interface. The company claims that its technology is able to identify when someone is at high risk of cardiovascular disease. 

“Multiple studies over the past several years, including the Framingham study published in 2010, have identified the measurement of PWV as one of the key biomarkers in assessing CV risk,” Dr. Judith Swain, chief medical officer at PhysioWave, said in a statement in Novemeber when the device was first revealed. “Until recently, measurements of this biomarker would require a dedicated room and technician at substantial expense. With PhysioWave Pro, it will soon be as simple as stepping on a weighing scale to capture this critical measurement and help guide the physicians’ next course of action.”

While PhysioWave is the first company to gain FDA clearance for a PWV feature housed within a home weight scale, it is not the first company to market the functionality. Earlier this year Nokia pulled the PWV feature on its Body Cardio scale fearing potential FDA regulations. 

At the time a Nokia representative told MobihealthNews that the decision to remove the feature was done proactively during a routine product review. The company also noted that the FDA did not recommend or require Nokia to remove the feature from the scale. The feature was removed from all Body Cardio scales, not just the ones sold in America. 

"It was a decision that wasn't taken lightly," a Nokia representative said in an email to Babyforyou.net.ua in January. "Nokia places great importance on the quality and reliability of its products and compliance with the current regulations. If we feel that any product does not meet these high standards, we take prompt action. With Body Cardio, we concluded that PWV may require a different level of regulatory approval in the US; given the lack of clear guidelines on the use of PWV as a measure of general wellness at home. We are being cautious and proactive by disabling the capability on the scale.”

The first PhysioWave Pro scales will be delivered to clinical customers later in 2018. 

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