The FDA has cleared a single-use two channel ECG and heart rate biosensor from California-based LifeSignals that provides 72-hour patient monitoring with remote data access in ambulatory, hospital and home settings.
 
The USFDA 510(k) clearance has been received for the ECG remote-monitoring patch platform, a wireless remote-monitoring system for use by healthcare professionals for the continuous collection of electrocardiography (ECG) and heart rate monitoring in ambulatory, hospital, home and healthcare settings.
 
Data are transmitted wirelessly from the LifeSignals LP1250 wireless medical biosensor to a remote secure 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.
 
“This FDA clearance represents a major step forward in our drive to untether patient monitoring systems,” said Surendar Magar, co-founder and CEO of LifeSignals. “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.”
 
Biosensor features include:

• 72-hour data capture of two-channel ECG and heart rate data for enhanced patient diagnosis;
• Single use device that reduces infection control concerns and operational costs;
• Lightweight and splash-proof for improved patient comfort and compliance; and
• Proprietary patented single-chip LC1100 life signal processor platform, allowing secure capture, storage and transmission of patient data even in noisy multi-patient hospital environments.

FDA clearance follows CE marking and HSA approval. The LP1250 will be sold worldwide as a white-labelled device through a network of partnerships from OEMs and telehealth software providers to specialist hospital facilities.