LifeSignals Group announced today that it received FDA 510(k) clearance for its LifeSignals ECG remote monitoring patch platform.
Fremont, Calif.-based LifeSignals developed the platform as a wireless remote monitoring system for healthcare professionals to continuously collect electrocardiography (ECG) and heart rate data in ambulatory, hospital, home and healthcare settings.
Data collected from the platform’s wireless medical biosensor LP1250 transmits wirelessly to a remote, secure server for storage and analysis for screening and monitoring common cardiac arrhythmias like atrial fibrillation, according to the company. The single-use biosensor offers 72-hour data capture, and is lightweight and splash-proof for improved comfort and compliance. Additionally, its single-chip, proprietary LC1100 LifeSignal processor platform allows for secure capture, storage and transmission of data.
LifeSignals’ monitoring technology already has CE Mark approval in Europe and HSA approval in Singapore. The company intends to sell its biosensor worldwide through partnerships with OEMs and telehealth software providers.
“This FDA clearance represents a major step forward in our drive to ‘untether’ patient monitoring systems,” LifeSignals co-founder & CEO Surendar Magar said in a news release. “The interoperable Biosensor gives partners access to a ready-to-integrate, multi-parameter medical wearable with a straightforward ecosystem for fast onboarding.
“Once in use, it enables remote patient monitoring services to be expanded rapidly and professionals can make faster treatment decisions while patients can be confident of receiving data-driven, personalized therapy.”