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CYBERDYNE’s Medical HAL Obtains FDA Marketing Clearance as Class II Medical Device

December 22, 2017 // 1 Comment

The Japanese exoskeleton manufacturer and one of the largest exoskeleton companies in the world, CYBERDYNE Inc., has obtained marketing clearance from the U.S. Food and Drug Administration (FDA) for its HAL for Medical Use (Lower Limb Type), also referred to as  “Medical HAL.”  Starting Dec 17th, the company can expand the marketing [more]

CYBERDYNE’s HAL Medical Comes to the U.S.

August 17, 2017 // 0 Comments

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) [more]

Exoskeleton Safety

September 20, 2016 // 1 Comment

“Basically, I’m here to announce we’re building Iron Man,” President Obama told the press in 2014. Yet while bold claims are being made about future exoskeleton technologies, it’s quite amusing to think that the industry’s largest current challenge may be simply creating devices that do not fall over. There are [more]

FDA Classifies Exoskeletons as Class II

March 7, 2015 // 1 Comment

The Department of Health and Human Services, Food and Drug Administration (FDA) announced on February 24th, 2015 that all powered exoskeletons will be classified as Class II devices. Taken directly from the FDA website: FDA classifies medical devices based on the risks associated with the device. Devices are classified into one of three [more]