FDA clears LifeSignals' wireless ECG biosensor LP1250

LifeSignals announced Tuesday the FDA 510(k) clearance of its electrocardiography (ECG) remote monitoring patch platform, which the company said is the "world's first" single-use two channel ECG and heart rate biosensor, called  LP1250, providing 72-hour patient monitoring with remote data access in ambulatory, hospital and home settings.

CEO Surendar Magar remarked that "this FDA clearance represents a major step forward in our drive to 'untether' patient monitoring systems." He added that "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."

LifeSignals explained that data is transmitted wirelessly from the LP1250 biosensor to a remote secure server for storage and analysis. The ECG remote monitoring patch was awarded the CE mark in May.

In early April, LifeSignals announced that its single-use, wireless biosensor patch for the early detection and monitoring of coronavirus symptoms was being fast-tracked "for introduction within weeks." For related analysis, see Spotlight On: Beyond IVDs and ventilators – Medtech's multifront battle against COVID-19.

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