Neurolutions with offices in Santa Cruz, CA and St. Louis, Missouri wins FDA de novo Permission to introduce the IpsiHand stroke rehabilitation system to the United States. This is the first approval of brain computer interface technology for the rehabilitation of stroke patients and promises a faster and more complete recovery of hand function in many patients.
The IpsiHand system utilizes the intact side of the brain to trigger the opening and closing of the robot’s exoskeleton, which is placed on the affected arm. The patient wears an EEG headset that interprets the relevant signals and sends them to the exoskeleton. According to Neurolutions, the idea is based on the concept that “neurons that fire together are wired together,” and it actually works when the patient wants to move his hand. This is repeated during multiple independent sessions at the clinic or at home. Clinical studies have shown that this repetitive enhancement significantly improves treatment outcomes, such as muscle re-education and increased range of motion, in patients well after stroke diagnosis (more than 6 months). ..
According to the manufacturer, we’ll take a closer look at this technology.
IpsiHand is intended for use in stroke rehabilitated patients over the age of 18 to promote muscle re-education and maintain or increase range of motion.
All participants in a 12-week, open-label, 40-patient study showed improvement in motor function with the device throughout the study. Reported adverse events included mild fatigue and discomfort, and temporary skin redness.
Product page: IpsiHand
https://www.medgadget.com/2021/04/first-brain-computer-robotic-stroke-rehab-system-authorized-by-fda.html The first brain computer robot stroke rehabilitation system approved by the FDA