Above, Eric Leuthardt, MD, a professor of neurosurgery at Washington University School of Medicine in St. Louis, models the IpsiHand Upper Extremity Rehabilitation System
A first-of-its kind device that helps people disabled by stroke regain significant arm and hand function by using their minds has received market authorization from the Food and Drug Administration (FDA).
The IpsiHand Upper Extremity Rehabilitation System, developed by Neurolutions Inc., allows patients to move their arms or hands with their thoughts using brain-computer interface (BCI) technology. Washington University’s Office of Technology Management patented the key discoveries and licensed them to Neurolutions.
The underlying BCI technology was spearheaded by Eric Leuthardt, MD, a professor of neurosurgery at Washington University School of Medicine. He co-founded Neurolutions in 2007 with Daniel Moran, PhD, a professor of biomedical engineering at the university’s McKelvey School of Engineering, to further develop the technology. Early St. Louis-based investors Biogenerator and Ascension Ventures were critical to the company’s development and technical advancement.
The IpsiHand system includes a wearable robotic exoskeleton that fits over a patient’s hand and wrist and assists with opening and closing the hand based on the patient’s thoughts. By mentally controlling the IpsiHand exoskeleton with the aid of BCI technology, patients may improve their upper extremity motor function, giving them more purposeful and effective movement of the affected hand, wrist and arm. Designed for use in the home or clinic, the IpsiHand system may assist stroke patients in recovering critical abilities such as feeding themselves, grasping objects and performing other everyday tasks, and is the first stroke-rehabilitation device that relies on a brain-computer interface.
The IpsiHand system has received “Breakthrough Device” designation from the FDA and has been granted De Novo marketing authorization by the FDA as well. The device is not yet available to patients, but Neurolutions is preparing to bring the device to market.