Valencia, Calif-based Bioness Inc reports that its L300 Go System, which received FDA clearance in January, has now received the CE Mark in the European Union.
The CE Mark now clears the way for Bioness to make the L300 Go System available to healthcare professionals and home users in Europe.
The functional electrical stimulation (FES) system is built to help increase mobility in individuals with lower limb paralysis or weakness.
Features include 3D motion detection of gait events from a 3-axis gyroscope and accelerometer, which detects movement in all three kinematic planes; as well as the myBioness mobile iOS application that allows users to track their progress, set goals, and evaluate their movements.
“We are pleased to have achieved this important regulatory milestone,” says Todd Cushman, president and CEO of Bioness, in the release. “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.”
The L300 Go System will be available to European users sometime in late summer 2017, per the release.
[Source(s): Bioness Inc, PR Newswire]