Ekso Bionics Inc. recently announced it has received FDA clearance to market its Ekso GT robotic exoskeleton to treat patients with hemiplegia due to stroke, patients with spinal cord injuries at levels T4 through L5 and patients with spinal cord injuries at levels T3 through C7 (ASIA D), in accordance with the device’s labeling.
According to a company press release, the Ekso GT is the first exoskeleton cleared by the FDA for use with stroke patients.
Ekso GT is a wearable robotic exoskeleton designed for rehabilitation institutions which enables its wearer to stand and walk over ground with full weight-bearing, reciprocal gait in a clinical setting. The device’s software allows it to provide adaptive amounts of power to either side of the wearer’s body.
“This clearance marks a major milestone toward our goal of establishing exoskeletons as standard of care in the rehabilitation clinic,” Thomas Looby, president and interim chief executive officer of Ekso Bionics, said in the release. “Our strategy has been to concentrate on the rehabilitation clinic, with a focus on ease of use, rapid turnover between sessions and efficacy for a range of patients.”
Source: Ekso Bionics
Looby added the approval could lead to broader adoption of exoskeletons by hospitals and rehabilitation clinics.
“I congratulate Ekso Bionics for [creating] the first exoskeleton to receive clearance for stroke,” W. Zev Rymer, director of the Research Planning and Sensory Motor Performance Program at the Rehabilitation Institute of Chicago, said. “[We] have seen the clinical value of the technology, and Ekso Bionics’ continued innovation now brings us the ability to provide this advanced technology to a broader population.”