Samsung Seeks FDA Approval for Wearable Exoskeleton Robot

Samsung Electronics is seeking approval from the U.S. Food and Drug Administration (FDA) for its assistive robot “GEMS Hip” a wearable device that acts as an exoskeleton for users with mobility issues, using an active assist algorithm to improve gait and muscle movement.

GEMS (Gait Enhancing & Motivating System) received the necessary certification for personal care robots for added safety in 2020, with a prototype of the bot unveiled at tech event CES 2022. 

“The certification will allow us to bring robots closer to our daily lives and enhance their accessibility and utility,” said Sungchul Kang, head of the robot center at Samsung Research at the time of certification. “We will utilize this momentum to further drive our commitment in robotics research.”

Samsung is anticipating the commercial launch of GEMS Hip will be in August, however, as the bot is intended for use as a medical assistant, Samsung has to receive FDA approval before it can be released to the market and awaiting this approval could push back the launch date.

In the design process for GEMS, it was noted that many automated wearable walking assists were limited by the high metabolic cost – with wearers experiencing muscle fatigue during and after use. Samsung’s offering, therefore, looked to reduce muscle effort from users, with company officials saying its bot can reduce the metabolic cost of walking by 24%, while accelerating the speed of a user by 14%.

Once approved, the initial supply of the robot will reportedly be around 50,000 units, with commercialization primarily focused on the U.S. market where demand for wearable robots for medical reasons has seen an increase of around 21% every year since 2016.