Wise’s Single-Use Cortical Strip CE Marked
Wise has received CE mark certification for its Wise Cortical Strip, a single-use device that is meant to be used on the surface of the brain for neurophysiological monitoring during surgery.
The first product in the company’s monitoring product line to earn the CE mark, the strip can be used to stimulate and record electrical activity in the brain, supporting monitoring during the resection of brain tumors or lesions capable of causing epileptic attacks.
The device is made of stretchable platinum contacts that are encased in a thin film of silicone, enabling high conformability to the surface of the brain. With the European clearance in hand, the company is now looking to earn FDA clearance for the strip.