The founder and chief scientific officer of Neurolutions discussed complexities within the system to integrate new stroke rehab devices.
"At the core, this has to be patient-centric. If it focuses on the patients, it allows us to have meaningful conversations with stakeholders and every element of that complex ecosystem.”
In April, the FDA announced the de novo market authorization and breakthrough device designation to Neurolutions’ IpsiHand Upper Extremity Rehabilitation System to treat patients with chronic stroke. The first FDA-approved device leveraging brain-computer interface technology includes a robotic exoskeleton that is worn over the patient’s hand and wrist, an electroencephalogram (EEG)-based headset, and a tablet.
The device utilizes the uninjured, or ipsilateral, side of the brain to improve arm and hand function and is indicated for patients 18 years and older. In recent years, the advancements in technology have opened the door for researchers to investigate electronic modalities such as the IpsiHand System and their capabilities in treating post-stroke patients. Eric Leuthardt, MD, founder and chief scientific officer, Neurolutions, noted his agreement with the FDA’s creation of pathways that expedite the process of these devices into the patient’s hands.
Leuthardt, who also serves as the division chief of neurotechnology and neurological surgery professor at the Washington University in St. Louis School of Medicine, sat down with NeurologyLive to detail how this tool will be streamlined for use in clinical care, along with the complexities that currently exist within the system.