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October 1, 2019
FDA Clears the FlowMet-R Blood Flow Monitoring System From Laser Associated Sciences
October 2, 2019—Laser Associated Sciences (LAS), a medical device company based in Irvine, California, announced that its FlowMet-R blood flow monitoring system received FDA 510(k) clearance.
According to LAS, the FlowMet-R is a noninvasive portable device that detects and measures treatment efficacy for peripheral artery disease. The device is compact and clips directly onto a patient’s toe. The technology includes a small laser diode and a camera the size of a postage stamp to measure blood flow in the digit in real time. This measurement reflects the severity of vascular disease upstream of the digit.
The FlowMet-R is intended to address the need for real-time intraprocedural monitoring to improve clinicians’ decision-making. In a recently completed clinical study, FlowMet-R measurements demonstrated improved accuracy in detecting advanced vascular disease compared with standard vascular assessments, advised the company.
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