FDA OKs CorVascular’s VasoGuard V-Series

CorVascular has earned U.S. Food and Drug Administration (FDA) clearance for its VasoGuard V-series, a suite of peripheral vascular testing devices.

The VasoGuard suite features five devices that each have a unique combination of sensors and abilities. These include up to three continuous wave Doppler probes with full spectrum, up to five wearable photoplethysmography (PPG) sensors, and up to ten pulse volume recording (PVR) channels.

The FDA nod expands access to diagnostic testing for PAD/PVD, which medical experts say is causing an amputation epidemic in the U.S.

VasoGuard achieved the FDA clearance following rigorous certification testing on the whole system, including electrical safety IEC 60601-1, electromagnetic disturbances IEC 60601-1-2, wireless immunity, cybersecurity, and all other standards required. These certifications included the device, touchscreen computer, mobile cart, and all accessories approved as a system.

“FDA 510(k) clearance of the VasoGuard V-Series is a significant achievement for our entire team who has been working diligently on this milestone for several years,” said Spencer Lien, founder and managing director at CorVascular. “The VasoGuard V-Series is the first full suite of devices designed for primary care, specialists, all the way up to and including the vascular testing labs in major health institutions and academic centers of excellence. It has been over a decade since anything new has come to this market and the VasoGuard is a perfect fit; the right line at the right time.”