B-Temia Grabs FDA 510(k) Clearance for Mobility-Assisting Exoskeleton

The FDA has granted 510(k) clearance for B-Temia’s Keeogo Dermoskeleton system for assisting stroke patients with walking.

The system, a robotic exoskeleton, is powered by the patient’s lower limbs, and uses software and motorized assistance to detect and support the patient’s movements.

The device is cleared for assisting stroke patients who experience gait deficits and is intended for use in rehabilitation settings under the supervision of a trained healthcare professional.