FDA Grants Investigational Device Exemption for Human Trial of Prosthetic Hand

The FDA awarded an investigational device exemption to Miami–based Florida International University for a human trial of its neural-enabled prosthetic hand system.

This device stimulates nerves in the arm to provide sensation as the person uses the prosthetic hand. The system has an implantable, wirelessly controlled Class-III device with electrodes that can be surgically implanted within the nerves of the arm.

Sensors embedded in the prosthetic hand send signals wirelessly to the implanted stimulator, which then elicits sensation with weak electrical pulses via the implanted electrodes. As a result, the user should be able to sense the hand opening position and grip items when the prosthetic hand encounters an object.

The device is not approved by the FDA for U.S. commercial distribution. — Cynthia Jessup