U.S. FDA clears optical sensor for noninvasive blood flow monitoring

Oct. 7, 2019

The noninvasive optical sensor addresses a critical unmet need for vascular specialists who are seeking improved methods to detect and measure treatment efficacy for peripheral artery disease.

Medical device maker Laser Associated Sciences (LAS; Irvine, CA) has received U.S. FDA approval for its FlowMet-R blood flow monitoring system, a noninvasive optical sensor that addresses a critical unmet need for vascular specialists who are seeking improved methods to detect and measure treatment efficacy for peripheral artery disease (PAD). PAD often goes undiagnosed and, when left untreated, can result in amputation.

The FlowMet-R device, which clips directly onto a patient's toe, 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 during intraprocedural monitoring, enabling vascular specialists to make better decisions about their treatment during surgery.

By directly measuring limb perfusion during surgeries, physicians can see whether peripheral blood flow is being improved in real time. This reduces the ambiguity that clinicians currently face in knowing not only if an intervention is effective, but how effective it is, according to Sean White, CEO of LAS.

The company also recently completed a clinical study in which FlowMet-R measurements demonstrated improved accuracy in detecting advanced vascular disease compared to standard vascular assessments. The company plans to publish the results soon, adds White.

LAS continues to collaborate with clinicians to develop new technologies that will improve outcomes for patients. The company is also exploring opportunities to build products for home use.

For more information, please visit laserassociatedsciences.com.