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LifeSignals Wireless Medical Biosensor LP1250 receives FDA clearance

Wednesday, July 22, 2020

LifeSignals Group, today announced USFDA 510(k) clearance has been received for their LifeSignals ECG Remote Monitoring Patch Platform. 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 Rate monitoring in ambulatory, hospital, home and healthcare settings. Data is transmitted wirelessly from the LifeSignals Wireless Medical Biosensor LP1250 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 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”

The LifeSignals Wireless Medical Biosensor LP1250 has several unique features:

  •     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
  •     Proprietary patented single-chip LC1100 Life Signal Processor platform, allowing secure detection, storage and transmission of patient data even in ‘noisy’ 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-labeled device through a network of partnerships from OEMs and telehealth software providers to specialist hospital facilities.

About LifeSignals, Inc.

LifeSignals is the leader in Wearable Medical Biosensors. LifeSignals provides a customizable biosensor ecosystem to create any clinical-grade, wearable biosensor solution. Its wearable medical biosensors wirelessly capture and transmit physiological data. LifeSignals biosensors are multi-parameter, low cost and disposable, and deliver clinical-grade accuracy that is reliable and secure. Based in Silicon Valley, and offices in New York, London, Ireland, Singapore and India, LifeSignals is a global venture capital backed company, enabled by equity investments from Flex, Uniquest, Dreamtech, Renew Group, Seraph Group, XSeed Capital, and Reddy Capital. Further information can be found at www.lifesignals.com.

Contacts
LifeSignals
Kim Ramessa
Product Marketing Manager
LifeSignals Group
M: +44 (0) 7425 316305
E: [email protected]

Media
Richard Hayhurst
RHApr
M: +44 (0) 7711 821527
E: [email protected]