Rehabilitation device maker Bioness said today it won CE Mark approval in the European Union for its L300 Go functional electrical stimulation system.
The L300 Go FES system is designed to help increase mobility in individuals with lower limb paralysis or weakness, and the company claims it is the 1st such system to offer comprehensive 3D motion detection of gait events from a 3-axis gyroscope and accelerometer.
“We are pleased to have achieved this important regulatory milestone. The market response to the technology after its debut in February has far exceeded our expectations as clinicians realize how the L300 Go can improve clinical efficiency and facilitate superior patient care,” CEO & prez Todd Cushman said in a press release.
Bioness said that it is hopeful for a European launch in late summer, and that the system won FDA clearance in January.