FDA grants clearance for neurological monitoring device

Medical device company WISE Srl announced the FDA granted clearance for its Cortical Strip, a single-use device intended to be used on the brain surface for intraoperative neurophysiological monitoring.

According to the company’s release, the novel device is the first to receive FDA clearance within the product family and follows the European CE mark already received by the product in May 2021.

The WISE Cortical Strip is intended for intraoperative use with recording, monitoring and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the brain surface, per the release. Unlike traditional cortical electrodes, which are made of stiff metal discs enclosed in a thick silicone foil, the WISE Cortical Strip is composed of stretchable platinum contacts embedded in a soft and thin film of silicone. As a result, the WISE Cortical Strip is highly ergonomic and conformable to the brain surface, the company stated.

“FDA clearance is a crucial milestone for our commercial development, allowing [us] to expand the distribution of the WISE Cortical Strip from Europe to the US and fueling the development of the WISEneuro Monitoring product family,” Luca Ravagnan, CEO of WISE stated in the release. “European clinicians are already demonstrating strong appreciation for the benefits of our product; we are looking forward to starting commercialization also in the U.S.”

Performance of the cortical strip has been successfully validated in a multicentric premarket clinical study in Europe, the WIN study, which demonstrated safety and usability of the product. The company further revealed in the release that a study featured in Clinical Neurophysiology showed that the WISE Cortical Strip performed better in terms of electrical impedance in physiological conditions than conventional cortical electrodes available on the market; the strip also demonstrated better adhesion, conformability and stability on the brain surface.