RICHMOND, California: (GLOBE NEWSWIRE) Ekso Bionics Holdings, Inc., a robotic exoskeleton company announced that it has received clearance from the U.S. Food and Drug Administration (FDA).
This allows for the Ekso GT robotic exoskeleton to be marketed for use in the treatment of individuals with hemiplegia due to stroke, individuals with spinal cord injuries.
The Ekso GT is the first exoskeleton cleared by the FDA for use with stroke patients.
Ekso GT is a wearable robotic exoskeleton that enables individuals to stand up and walk over ground with a full weight bearing, reciprocal gait in a clinical setting.
The Ekso GT with smart Variable Assist* software, which was designed for rehabilitation institutions, provides adaptive amounts of power to either side of the patient’s body, engaging the patient throughout his or her continuum of care.
The technology provides the ability to mobilize patients early in their recovery, frequently, with a significant number of high intensity steps.
To date, the Ekso has helped patients take more than 41 million steps in over 115 rehabilitation institutions around the world.
“This clearance marks a major milestone towards our goal of establishing exoskeletons as standard of care in the rehabilitation clinic,” commented Thomas Looby, president and interim chief executive officer of Ekso Bionics.
“Our strategy has been to concentrate on the rehabilitation clinic, with a focus on ease of use, rapid turn-over between sessions, and efficacy for a range of patients.
Clinics using the Ekso GT are able to offer exoskeleton therapy to the widest patient population among all exoskeletons on the market, which we believe will translate into broader adoption of exoskeletons by hospitals and rehabilitation clinics and better outcomes for patients.”
Each year, an estimated 375,000 people suffer a spinal cord injury globally and an estimated 17 million people suffer a stroke and over 60% of acute stroke survivors are unable to walk or need intervention in walking.
Founded in 2005, Ekso Bionics is a leading developer of exoskeleton solutions that amplify human potential by supporting or enhancing strength, endurance and mobility across medical, industrial and defense applications.