LifeSignals Get FDA 519 (k) Approval for LifeSignals LX1550...
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LifeSignals Get FDA 519 (k) Approval for LifeSignals LX1550 Multiparameter Remote Monitoring Platform

Healthcare Tech Outlook | Wednesday, August 18, 2021

A single-use wearable multiparameter biosensor is at the heart of the platform, recording electrocardiography (2-channel ECG), heart rate, respiration rate, skin temperature, and body posture for up to five days.

FREMONT, CA: LifeSignals, a leader in wearable biosensors, recently announced that the LifeSignals LX1550 Multiparameter Remote Monitoring Platform has achieved FDA Class II 510 (k) approval. This comes on the heels of LifeSignals’ recent CE certification, and it demonstrates the company’s commitment to developing new wireless platforms that doctors can use to collect continuous patient physiological data at home and in hospital settings.

“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.”

A single-use wearable multiparameter biosensor is at the heart of the platform, recording electrocardiography (2-channel ECG), heart rate, respiration rate, skin temperature, and body posture for up to five days. The biosensor’s encrypted physiological data can then be reliably sent to a secure cloud-based platform via a relay app. Clinicians and Care Providers can view patient physiological data and modify alert settings using the cloud-based remote monitoring dashboard.

The Remote Monitoring Platform is intended to help healthtech companies rapidly expand their product and service portfolios in order to deliver vital sign monitoring to as many patients as possible from any place. The relay app and dashboard are developer-friendly, with ready-to-deploy software development kit APIs, and are appropriate for large-scale implementation.

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