Wise’s Cortical Strip Gains FDA Clearance for Open Brain Surgery
The FDA granted Wise clearance for its Cortical Strip medical device to monitor nervous system function during open brain surgery.
The device features stretchable platinum contacts in a pliable silicone film. The film is placed directly on the brain and connects to recording, monitoring and stimulation equipment to capture electrical signals. Current conventional cortical electrodes use stiff metal discs in a thick silicone foil, the company said.
The Cortical Strip received the European CE mark in May 2021.