LifeSignals Group, has received FDA 510(k) clearance for its ECG Remote Monitoring Patch Platform.
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The LifeSignals ECG Remote Monitoring Patch Platform is a wireless remote monitoring system intended for use by healthcare professionals for the continuous collection of electrocardiography (ECG) and heart tate monitoring in ambulatory, hospital, home and healthcare settings. Data is transmitted wirelessly from the LifeSignals Wireless Medical Biosensor LP1250 to a remote server for storage and analysis.
Healthcare professionals can remotely access patient data via third-party software for the screening and monitoring of common cardiac arrhythmias such atrial fibrillation, enabling rapid treatment decisions, independent of patient location.
Surendar Magar, co-founder and CEO of LifeSignals, said: “This FDA clearance represents a major step forward in our drive to “untether” patient monitoring systems. The interoperable biosensor gives partners access to a ready-to-integrate, multi-parameter medical wearable with a straightforward ecosystem for fast on-boarding. 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, personalised therapy.”
The LifeSignals Wireless Medical Biosensor LP1250 has features including:
- 72-hour data capture of two-channel ECG and Heart Rate data for enhanced patient diagnosis.
- Single-use device that aims to reduce infection control concerns and operational costs.
- Lightweight and splash-proof.
- Proprietary patented single-chip LC1100 Life Signal Processor platform, allowing capture, storage and transmission of patient data in multi-patient hospital environments.
FDA clearance follows CE marking and HSA approval. The LifeSignals Wireless Medical Biosensor LP1250 will be sold worldwide as a white-labelled device.
