LifeSignals today announced that it has received FDA 510(k) clearance for its LX1550 multi-parameter remote monitoring platform.
Fremont, Calif.–based LifeSignals designed the LX1550 to continuously collect patient physiological data from home and in healthcare settings.
The platform has a single-use wearable multi-parameter biosensor that records electrocardiography (ECG), heart rate, respiration rate, skin temperature and body posture data for up to five days. The encrypted data can be transmitted from the biosensor through a relay app to a secure cloud-based platform where clinicians and care providers can access the monitoring dashboard.
“COVID-19 has broken down the barriers to remote patient monitoring globally, and I am proud of how the LifeSignals team has responded to develop the Platform in such a short space of time,” founder and CEO Surendar Magar said in a news release. “This FDA 510(k) approval marks another major milestone in the company’s development and mission. It has already been implemented successfully in hospitals for monitoring COVID-19 patients in India and is being rolled out in Europe, U.K., Singapore and the Philippines. Our focus now is to rapidly introduce low-cost remote vital sign monitoring to US health tech companies looking to expand their services and improve patient care.”