FDA Approval and Ekso Bionics

U.S. Food and Drug Administration gave us clearance to market our robotic exoskeleton, EksoNR, for use with patients with acquired brain injury (ABI).

As EksoNR is the first exoskeleton device to receive FDA clearance for rehabilitation use with ABI, this significantly expands the device’s indication to a broader group of patients.

EksoNR for NeuroRehab

EksoNR is the next generation device of the most clinically-used robotic exoskeleton, EKsoGT, and was previously cleared by the FDA for stroke and spinal cord injury rehabilitation in 2016. The device was the first of its kind to receive a stroke indication and is now also the first to receive an ABI indication.

Physical Therapist assisting a patient take steps using Ekso Bionics, EksoNR.

What is ABI?

ABI, acquired brain injury, is the broadest category of brain injury and is comprised of both traumatic (TBI) and non-traumatic (n-TBI) causes. TBI includes severe head injuries and concussions, while n-TBI includes a broader subset of conditions, such as stroke, aneurysms, brain tumors, anoxia, degenerative and metabolic conditions, infections, and surgical injuries, among others. The combined annual incidence of TBI and stroke alone represent an estimated patient population of 3.7 million in the U.S. and 84 million globally.

What does this new indication mean?

ABI clearance is a huge step towards our goal of elevating patient care and helping people regain mobility.

“With the expanded indications to include the broad category of acquired brain injuries, EksoNR has the potential to mobilize significantly more patients and improve patient recovery. Based on their experience with EksoNR, customers at leading rehabilitation centers have acknowledged the benefits our technology can offer during recovery from brain injuries.”

— Jack Peaurach, CEO & President of Ekso Bionics

As Ekso Bionics CEO & President stated, “At Ekso Bionics, we are committed to maximizing patient access to our technology. With the expanded indications to include the broad category of acquired brain injuries, EksoNR has the potential to mobilize significantly more patients and improve patient recovery. Based on their experience with EksoNR, customers at leading rehabilitation centers have acknowledged the benefits our technology can offer during recovery from brain injuries. We are excited to see the device used more widely in neurorehabilitation.”

In addition to EksoNR’s FDA clearance for stroke, spinal cord injury, and acquired brain injury rehabilitation, the device is also CE-marked and available in Europe. Utilized by over 270 rehabilitation centers around the world, Ekso device has helped patients take more than 120 million steps, while supporting patients’ hopes of early mobility and independence.

To learn more about EksoNR, request a demo today.