Biosensor wearables, telemedicine, and remote patient management (RPM) feature in our posts frequently. The pace of RPM and telemedicine developments increased with COVID-19 due to the increased risk from person-to-person contact. Santa Clara-based HD Medical Group recently introduced HealthyU, a remote patient monitoring device. HealthyU provides patients and physicians a wide range of vital signs and medical information.
HealthyU is a handheld device for home use that provides wireless 7-lead ECG, heart sounds including murmur analysis, lung sounds, heart rate, pulse oximetry (SpO2/blood oxygen saturation), temperature, respiratory rate, and cuffless blood pressure trend data. Patient and physician connect via a mobile app and HD Medical Group’s HD Cloud Platform for Intelligent Insights. The platform also supports video conferencing and screen sharing. HealthyU expects to receive FDA clearance by the third quarter this year, but it is currently available to clinical research partners, corporate wellness partners. and telehealth pilot programs under the FDA’s Institutional Review Board (IRB) protocol. HD Medical Group intends to seek FDA Emergency Use Authorization (EUA) to use HealthyU to support telemedicine and RPM while the pandemic is still in force and later.
The FDA cleared HD Medical Group’s HD Steth 3-in1 smart stethoscope in 2020, according to the company. The HD Steth is a combination electronic stethoscope, phonocardiograph, and electrocardiograph. Physicians can use the HD Steth to listen to live heart and lung sounds during in-person meetings but there is no mention of employing the HD Steth in remote monitoring.
HD Medical Group plans to begin selling HealthyU in the U.S. by the third quarter 2021, pending FDA clearance. Pricing information for HealthyU was not included in the product introduction, but as a point of reference HD Steth sells for $500.
