By Diagnostics World Staff
January 12, 2020 | Valencell today announced that its calibration-free, cuffless blood pressure (BP) technology for wearables is now able to be used in devices worn on the finger and wrist. The technology, which brings cuff-like BP accuracy to other parts of the body, was first announced in January 2020 for hearables, hearing aids and other ear-based devices. This latest advancement significantly expands the number of device form factors to embed the technology, including smartwatches, fitness bands, patches and pulse oximeter finger clips.
According to the CDC, hypertension affects nearly one-third of Americans, or 75 million people, aged 18 or older. Additionally, for approximately one-half of adults with hypertension (nearly 35 million people), it is uncontrolled.
Valencell conducted its 2020 Blood Pressure Research Survey from November 5-9, 2020. The online survey polled 787 U.S consumers, ages 18 and up, to understand how they manage hypertension and how that experience could be improved. The company found that 62% of Americans with hypertension report only measure their BP a few times a month or less, far below expert recommendations of twice daily. Only 4% reported measuring BP more than once a day. However, more than 75% of respondents said they would measure their BP “more or much more” often if they could accurately measure passively in the background, which cuff-less options like smartwatches and audio earbuds would enable.
When offered a list of alternatives, 41% said they would prefer finger clip or pulse oximeter clip, 40% preferred a sensor in a watch, 30% preferred a phone sensor, 20% voted for a fitness band, and 10% liked an earbud option.
Valencell’s BP technology that can be built into a range of passive form-factors worn in the ear, on the finger and on the wrist makes it significantly easier for people to monitor their BP on a regular basis, allowing them to build potentially life-saving habits. Valencell is pursuing FDA clearance for this technology in early 2021 to help manufacturers who embed the technology in their devices moving forward with the clearance process.
Unlike other sensor modalities such as ECG or pulse transit time, the Valencell BP technology does not need to be calibrated to a BP cuff and only requires data from photoplethysmography (PPG) and inertial sensors that are already in widespread use in wearables today. This data, along with a subject’s physical characteristics (age, weight, gender, height), is processed by the Valencell BP estimation software in an embedded model created using machine learning techniques and data from tens-of-thousands of patient results. Valencell is now the first commercially available embedded sensor solution to enable BP readings throughout the day with the same accuracy as current BP cuff devices without the need for a cumbersome cuff.
“Our survey results solidify the next frontier in medical wearables, which is to make a measurable impact on the global hypertension crisis through passive technologies that people will actually use regularly,” said Dr. Steven LeBoeuf, President and co-founder of Valencell in a press release.“Huge opportunities exist to ease the burden of blood pressure monitoring and reduce the cost of healthcare with non-invasive sensor technology embedded in devices people wear every day. In fact, the marketplace has recently validated the importance of regular BP self-monitoring with two new CPT codes—99473 and 99474 –supporting reimbursement for home BP monitoring.”