Laser Associated Sciences (LAS), a Cove @ UCI Applied Innovation tenant, recently received their first 510(k) FDA clearance for their device, the FlowMet-R. The 510(k) FDA clearance is a premarket submission made to the FDA that signifies the device is safe and effective.
FlowMet-R is a light-based technology for measuring peripheral blood flow. LAS aims to get the device into the hands of doctors who perform revascularization surgeries, a type of surgery that opens up a patient’s blood vessels to address vascular disease, specifically peripheral artery disease (PAD).
“It’s a huge milestone for us that enables us to market and sell the device,” said Sean White, CEO of LAS.
PAD affects over 8.5 million people nationwide, according to the American Heart Association. It is considered a narrowing of the peripheral arteries that serve the legs, stomach, arms and head. PAD often goes undiagnosed and, if left untreated, can result in gangrene and amputation.
LAS will soon perform their biggest clinical study to date, with a plan to enroll 300-400 people. The study will include measurements of the patients’ blood flow that will be taken with the FlowMet-R, as well as several other standard assessments in vascular care, such as the ankle-brachial index and the toe-brachial index will be performed.
“We’ve gotten a lot of really positive feedback from doctors,” said White. “The FlowMet-R technology provides much-needed insight into to the efficacy of revascularization surgeries for doctors to use in real time. For that reason, the operating room is where we see the technology being adopted first, and we’re really excited to see that.”
Find out more information about LAS.
*Pictured from left to right: Tyler Rice, CTO, Sean White, CEO and Bruce Yang, Chief Engineer