LifeSignals receives FDA 510 (k) Approval for LifeSignals LX1550 Multiparameter Remote Monitoring Platform
PR90873
FREMONT, Calif. July 27, 2021 /PRNewswire=KYODO JBN/
Further validation of ability to deliver continuous remote patient vital signs
monitoring within both hospital and home settings.
LifeSignals Inc., today announced it has received FDA Class II 510 (k) approval
for the LifeSignals LX1550 Multiparameter Remote Monitoring Platform. This
follows recent CE marking and is further validation of LifeSignals' drive to
create innovative wireless platforms which 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 Electrocardiography (2-channel 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 high 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 enable healthtech companies to
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 is 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," says Surendar Magar, Founder and CEO.
"This FDA 510 (k) approval marks another major milestone in the company's
development and mission. It has already been implemented successfully in
hospitals for monitoring COVID-19 patients in India 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."
www.lifesignals.com
Photo - https://mma.prnewswire.com/media/1582121/LifeSignals.jpg
SOURCE: LifeSignals Inc
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