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FDA Clears Medical Device to Help Detect Peripheral Artery Disease


The non-invasive device showed improved accuracy in detecting advanced vascular disease.

blood cells

Photo/Thumb have been modified. Courtesy of rost9 - stock.adobe.com.

Laser Associated Sciences today announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its blood flow monitoring system which could help vascular specialists detect and measure treatment efficacy for peripheral artery disease.

The system, FlowMet-R, is a non-invasive portable device that clips onto a patient’s toe. FlowMet-R includes a laser diode and camera to measure blood flow in the digit in real time, the medical device company said. The measurement reflects the severity of vascular disease.

“By directly measuring limb perfusion during surgeries, physicians can see for the first time whether peripheral blood flow is being improved in real time,” said Sean White, Ph.D., co-founder and CEO of Laser Associated Sciences. “This reduces the ambiguity that clinicians currently face in knowing not only if an intervention is effective, but how effective it is.”

Peripheral artery disease is a condition that affects more than 200 million people worldwide, according to the American Heart Association. The disease often goes undiagnosed and being left untreated can result in amputation.

The FDA clearance comes after a clinical study tested the efficacy of FlowMet-R. In a statement to Inside Digital Health™, White said 167 limbs were enrolled in the study. FlowMet-R measurements, Ankle Brachial Index (ABI), Toe Brachial Index (TBI)and Rutherford Class were recorded for each limb, he said. The FlowMet-R blood flow measurements were significantly correlated with ABI and TBI measurements. The medical device showed improved accuracy in detecting advanced vascular disease compared to standard vascular assessments.

With the FDA clearance, Laser Associated Sciences will market and sell the FlowMet-R.

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