Industrial conglomerate Parker Hannifin Corporation, which deals in motion and control technologies, announced Thursday that the U.S. Food and Drug Administration (USFDA) has given the clearance to market and sell the Indego exoskeleton for clinical and personal use in the U.S.
Indego is a robotic exoskeleton or powered orthotic device that allows users to stand and walk and could be of help for people suffering with paraplegia.
Each device weighs 26 pounds and costs about $80,000, according to the Indego website.
With this announcement, Parker joins ReWalk Robotics Ltd. as the only two companies in the U.S. that have received permission from the USFDA to sell the wearable exoskeleton devices to both individuals and hospitals.
The company intends to commercially launch the device in the U.S. in the coming months. Indego is already commercially available in Europe, having received the CE Mark in November 2015. "In a relatively short amount of time, we have taken what was a prototype device and readied it for full commercial launch," said Tom Williams, chairman and CEO of Parker Hannifin.
The USFDA's nod came after the completion of one of the largest exoskeleton clinical trials conducted to date in the U.S.
"With the regulatory barriers addressed, we look forward to a full commercial launch of the device and further studies that will provide evidence of the economic and health benefits of exoskeleton technology," said Achilleas Dorotheou, head of the human motion and control business unit for Parker.
It is estimated that the annual incidence of spinal cord injury (SCI) is approximately 40 cases per million population in the U.S. or about 12,500 new SCI cases each year, according to the National Institute on Disability, Independent Living, and Rehabilitation Research.