Device for noninvasive brain biopsies via blood draw moves closer to market approval

The Source • November 20, 2023January 8, 2024

Graduate student Lu Xu (center) wears a device co-invented by Washington University’s Eric C. Leuthardt (left), a professor of neurosurgery at the School of Medicine, and by Hong Chen (right), an associate professor of biomedical engineering at the university's McKelvey School of Engineering. The technology was developed so that noninvasive biopsies could be performed in adults with brain tumors. It has been granted U.S. Food and Drug Administration "Breakthrough Device" designation, which helps accelerate the process toward market approval. (Photo courtesy of Hong Chen)

FDA grants WashU-based technology ‘Breakthrough Device’ designation

A device aimed at enabling neurosurgeons and other physicians to perform noninvasive blood-based biopsies in adults with brain tumors has received Food and Drug Administration (FDA) “Breakthrough Device” designation. The device includes technology from Washington University in St. Louis and developed by Cordance Medical Inc., a medical device company in Mountain View, Calif.