WebApr 23, 2024 · IpsiHand uses non-invasive electroencephalography (EEG) electrodes — instead of an implanted electrode or other invasive feature — to record brain activity. EEG data is then wirelessly transmitted to a tablet for analysis of the intended motor function and the signal is sent to a wireless electronic hand brace designed to move the patient’s hand. WebApr 10, 2024 · The United States Food and Drug Administration (FDA) authorised the use of a brain-computer interface device to assist stroke patients with hand, wrist, and limb impairments in April 2024.
Neurolutions Receives U.S. Food and Drug Administration De
WebApr 4, 2024 · The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De Novo classification option as an alternate pathway to classify novel medical devices that had automatically been... WebApr 26, 2024 · IpsiHand includes a wearable robotic exoskeleton that is worn over the patient’s hand and wrist, a tablet computer, and an EEG-based biometric headset. IpsiHand exoskeleton uniquely leverages... shutterstock video no watermark
Neurolutions Receives U.S. Food and Drug Administration De …
WebMay 3, 2024 · The IpsiHand System has been cleared for use in chronic stroke patients to facilitate muscle re-education through its novel BCI platform. In addition to the De Novo Authorization, the IpsiHand device notably received Breakthrough Device designation from the FDA as well. WebApr 23, 2024 · The FDA assessed the safety and effectiveness of the IpsiHand System device through clinical data submitted by the company, including an unblinded study of 40 patients over a 12-week trial. All... WebApr 29, 2024 · Neurolutions, a company with offices in Santa Cruz, CA and St. Louis, MO, won FDA de novo authorization to introduce its IpsiHand stroke rehab system in the … the pampered peach wax bar of lake mary