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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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