BrainCo's Intelligent Bionic Hand receives FDA 510(k) clearance

BrainCo/Intelligent Bionic Hand

The Intelligent Bionic Hand received FDA 510(k) clearance in November 2022, establishing it as the first FDA-cleared non-invasive BCI-based prosthetic device, enabling commercial distribution in the U.S. market.

• First FDA clearance for a non-invasive BCI-controlled prosthetic hand
• Enables broader clinical adoption and U.S. commercial distribution
• Retails at $10,000-$15,000, substantially less than comparable prosthetics at $40,000-$60,000