Latest from ABILITY

Stay up to date with our latest research, milestones, and company news.

Regulatory March 2026

ABILITY Submits Breakthrough Device Designation Request to FDA

ABILITY has submitted a Breakthrough Device Designation (BDD) request to the U.S. Food and Drug Administration. If granted, this designation will provide ABILITY with priority review, increased FDA interaction, and a streamlined pathway to market for our speech neuroprosthesis. This submission reflects the novel nature of our technology and its potential to address an unmet clinical need for patients who have lost the ability to speak.

Regulatory March 2026

ABILITY Submits IMDD Technical File for First-in-Human Study

A major milestone for ABILITY — we have officially submitted our Investigational Medical Device Dossier (IMDD) technical file, marking a decisive step toward our First-in-Human clinical trial. This submission represents years of engineering, preclinical validation, and rigorous quality work culminating in a comprehensive regulatory package. The entire team came together to celebrate this pivotal moment in our journey to restore communication for patients who need it most.

Engineering February 2026

Inside ABILITY's Verification Campaign

Months of rigorous testing, validation, and engineering effort captured in one video. From environmental stress tests and impact testing to electrical verification and device soak trials — watch our team put the ABILITY implant through its paces on the road to First-in-Human.

Company January 2025

ABILITY Neurotech Launches as Spin-Out from the Wyss Center

ABILITY Neurotech is born — spun out from the Wyss Center for Bio and Neuroengineering in Geneva, Switzerland. Built on years of pioneering brain-computer interface research, ABILITY launches with a clear mission: to develop a fully implantable speech neuroprosthesis that restores communication for people who have lost the ability to speak. With deep roots in neuroscience and a world-class founding team, ABILITY sets out to bring next-generation BCI technology from the lab to the patient.