After many years, the HAL – Lower Limb Exoskeleton for Medical Use by CYBERDYNE Inc. has finally arrived in the U.S. HAL stands for Hybrid Assistive Limb and is one of the most respected exoskeletons in the world.
- In June, the company published a press release that it has applied with the United States Food and Drug Administration (FDA) for approval to market the Medical HAL as a Class II medical device.
- In July, the Seattle Science Foundation released a twenty-minute in-depth presentation on their experience working with the HAL.
Presentation by the Seattle Science Foundation
Taken from YouTube: “Seattle Science Foundation is a non-profit organization dedicated to the international collaboration among physicians, scientists, technologists, engineers, and educators. The Foundation’s training facilities and extensive internet connectivity have been designed to foster improvements in health care through professional medical education, training, creative dialogue and innovation.”
What does this mean for the Exoskeleton Industry?
Until now, Germany has been the battleground for medical exoskeleton rivalry. Germany itself does not have much internal exoskeleton development but has facilitated the import and testing of devices from all over the world. With Ekso Bionics and ReWalk Robotics currently struggling to find footing and shedding employees, CYBERDYNE has a perfect opportunity to move into the U.S. from the East and the West via its Japanese and German offices (Note: Google Maps currently shows CYBERDYNE already with an office in Seattle, Washington).
It is not clear how long it will take for the HAL Medical to be cleared for use in the U.S., but when it does it will join in the discussion of how to approach mobile exoskeleton gait assist rehabilitation:
- Ekso GT by Ekso Bionics – variable assist software
- ReWalk 6 by ReWalk Robotics – emphasis on using the device for as long as possible
- Phoenix by SuitX – make the device more accessible, motors only at the hip
- Indego by Paker Hannifin – FES integration
- HAL Medical by CYBERDYNE – bio-electrical signal control
CYBERDYNE was named one of the 50 most innovative companies in 2017 by the German version of Technology Review, Das Magazin Für Innovation:
Main article (in German only, paid access only) https://www.heise.de/select/tr/2017/9/1503855496488261
List of companies considered (again, in German)
As the exoskeleton industry grows and matures its companies are gaining more recognition and awards: Exoskeleton Awards Highlights Q2 2017
The Application for Market Approval of Medical HAL as a Medical Device Used for Innovative Cybernics Treatment has been Submitted to the US FDA, June 20th, 2017, CYBERDYNE News, https://www.cyberdyne.jp/english/company/PressReleases_detail.html?id=5789
Gait Rehabilitation with a Neurologically Controlled Exoskeleton – Ziadee Cambier, PT, MSPT, DPT, July 19th, 2017, https://www.youtube.com/watch?v=R3Fl_X3hdm4&feature=youtu.be