Home » Spino Modulation’s Scoliosis Device Wins FDA’s Breakthrough Device Designation
Spino Modulation’s Scoliosis Device Wins FDA’s Breakthrough Device Designation
Devices Submissions and Approvals
Montreal, Canada-based Spino Modulation has won a Breakthrough Device designation from the FDA for its MIScoli system for the treatment of scoliosis in young adolescents.
The Spinologics subsidiary describes MIScoli as a vertebral body-tethering device and a less-invasive alternative to spinal fusion, the current standard of care when adolescents need surgery to correct a curvature of the spine.
Breakthrough Device status, which the FDA grants for products intended to help patients receive more timely access to devices to treat life-threatening or debilitating diseases or conditions, includes a priority review by the agency of regulatory submissions.