Continuous vital sign monitoring that produces clinical-grade data while wearers go about their daily lives is a shiny brass ring for the wearable technology industry. We’ve argued in the past that passive devices that track data with no active user involvement will boost patient compliance. Such wearables also can support wearers and their care teams via remote patient monitoring (RPM). In 2019 we wrote about Biobeat‘s wrist-worn and single-use patch wearables that worked with a software platform to track data for vital sign trends and alerts. The Biobeat Watch and Biobeat Patch both have a photoplethysmography (PPG) sensor, galvanic skin response (GSR) sensor, temperature sensing, and an accelerometer. The Patch also has a single-lead ECG.
Biobeat recently announced its launch of a disposable, single-use chest monitor wearable capable of continuous ambulatory blood pressure monitoring (ABPM). According to Biobeat, the chest monitor measures diastolic and systolic blood pressure, heart rate, mean arterial pressure, cardiac output, and systemic vascular resistance. Onboard sensors transmit data to a smartphone app where the data is accessible to patients and their care teams. The Chest Monitor has a battery life of up to six days. The Biobeat Chest Monitor can work with the company’s Early Warning Score (EWS) System with customizable thresholds for automated real-time alerts.
We are fans of RPM and the promise of wearables with continuous vital sign monitoring. We want Biobeat’s device to meet its promise. Our impression to date, however, is the clinical data that Biobeat claims supports the company’s ABPM cuffless monitor as a reliable and accurate solution for out-of-clinic blood pressure monitoring is a bit thin. We inquired about the study mentioned in the news release for the chest monitor. A Biobeat representative send a PDF of an accepted manuscript of a study of a different Biobeat monitor — the wrist-worn device — that was published in the American Journal of Hypertension. Two of the study authors are Biobeat employees. The study is observational in nature with no control group. In the study conclusion, the authors wrote, “Further studies are needed to confirm the accuracy of the device in hypertensive patients and in other subpopulations.”
All fair and good, except that in our opinion the news announcement and the publicly-viewable abstract overstate the study’s value. We’ve reached out to Biobeat for documentation that supports comparable performance with the wrist-worn and chest monitor form factors. We also asked about additional documented clinical studies. We’ll report back when we receive additional information.
Here is another study for your review. https://www.prnewswire.com/news-releases/clinical-study-highlights-accuracy-of-biobeats-wearable-cuffless-blood-pressure-monitoring-device-when-compared-to-traditional-cuff-based-devices-301145609.html