Medical device firm WISE has received US Food and Drug Administration (FDA) approval for its WISE Cortical Strip, a single-use device for neuromonitoring.
The new device has been designed for Intra Operative Neurophysiological Monitoring (IONM) from the surface of the brain.
It is claimed to be the first product in the company’s WISEneuro Monitoring product portfolio to receive FDA clearance.
The latest move comes after the WISE Cortical Strip received CE mark approval in May 2021.
Developed using Supersonic technology, the new strip can be used for intraoperative use with monitoring, recording and stimulation equipment to record the brain’s spontaneous electrical activity (ECoG) and somatosensory evoked potentials (SEPs).
It can also be used for brain stimulation to elicit motor-evoked potentials (MEPs).
The strip is composed of stretchable platinum electrodes, which are embedded in a soft and thin film of medical-grade silicone.
WISE CEO Luca Ravagnan said: “The FDA clearance is a crucial milestone for our commercial development, allowing to expand the distribution of the WISE Cortical Strip from Europe to the US and fuelling the development of the WISEneuro Monitoring product family.
“European clinicians are already demonstrating strong appreciation for the benefits of our product, we are looking forward to starting commercialisation also in the US.”
The performance of the WISE Cortical Strip was validated in a multicentric pre-market clinical study in Europe.
In the WIN study, the strip demonstrated better performance in terms of electrical impedance in physiological conditions compared to the conventional cortical electrodes that are currently available on the market.
It also showed better adhesion, stability and conformability on the brain surface.