CorTec’s Brain Interchange™ Joins FDA TAP Program

CorTec GmbH announced the inclusion of its Brain Interchange™ system in the FDA's Total Product Life Cycle Advisory Program (TAP). This development follows its FDA Breakthrough Device Designation. The Brain Interchange™ aims to enhance stroke motor rehabilitation, with its recognition marking a notable milestone for CorTec.

Acceptance into TAP offers CorTec strategic support from clinical development to market accessibility, reducing regulatory risks. The program enhances interaction with key stakeholders, including Medicare & Medicaid, which is pivotal in establishing new therapy reimbursement frameworks.

The company's ongoing NIH-funded trial recently saw the successful implantation of a third patient at Harborview Medical Center. This trial expands data collection and supports the device's reliability and effectiveness in varying stroke profiles.

Incorporating both regulatory achievements and clinical advancements, CorTec continues to make strides in the neurotechnology sector. The company’s developments underscore the competitive edge of European innovations.