FDA grants marketing authorization for stroke rehabilitation device

The FDA announced in a press release its marketing authorization and breakthrough device designation of the IpsiHand Upper Extremity Rehabilitation System from Neurolutions Inc. for use in stroke patients.

The IpsiHand system is a brain-computer-interface device that uses noninvasive electroencephalography electrodes to record brain activity. According to the release, the device is designed to facilitate muscle re-education and range of motion in stroke patients with hand, wrist or arm disability.

“Thousands of stroke survivors require rehabilitation each year,” Christopher M. Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA Center for Devices and Radiological Health, said in the release. “Today’s authorization offers certain chronic stroke patients undergoing stroke rehabilitation an additional treatment option to help them move their hands and arms again and fills an unmet need for patients who may not have access to home-based stroke rehabilitation technologies,” Loftus said.