FDA says yes to LifeSignals wireless platform

  • August 9, 2021
  • Steve Rogerson

California-based LifeSignals has received FDA Class II 510 (k) approval for its LX1550 multiparameter remote-monitoring platform.

This follows recent CE marking for the wireless platform that can be used by clinicians for the continuous collection of patient physiological data at home and in healthcare settings.

Central to the platform is a single-use wearable multiparameter biosensor that records two-channel electrocardiography (ECG), heart rate, respiration rate, skin temperature and body posture data for up to five days.

The encrypted physiological data can then be transmitted with reliability from the biosensor, via a relay app to a secure cloud-based platform. Clinicians and care providers can access the cloud-based remote-monitoring dashboard to view patient physiological data and manage alert settings.

The remote-monitoring platform is designed to let healthtech companies rapidly enhance their product and service portfolios to provide vital sign monitoring to the widest possible patient base, from any location. The relay app and dashboard are developer-friendly with ready-to-deploy software development kit APIs and are suitable for large scale implementation.

“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,” said Surendar Magar, LifeSignals CEO. “This FDA 510 (k) approval marks another major milestone in the company’s development and mission.”

The platform has already been implemented in hospitals in India for monitoring Covid-19 patients and is being rolled out in Europe, UK, Singapore and the Philippines.

“Our focus now is to rapidly introduce low-cost remote vital sign monitoring to US healthtech companies looking to expand their services and improve patient care,” said Magar.

LifeSignals provides a flexible biosensor platform to enable partners to create clinical-grade, remote monitoring products. Its biosensors are multi-parameter, low cost and disposable, and deliver clinical-grade accuracy.

Based in Silicon Valley, LifeSignals has offices in New York, London, Ireland, Singapore and India, and is backed by equity investments from Flex, Uniquest, Dreamtech, Renew Group, Seraph Group, XSeed Capital and Reddy Capital.