Canary Medical earned the FDA's breakthrough designation for its smart lumbar spine cartridge, the devicemaker said May 29.
The Canturio Lumbar Cartridge is designed for lumbar spinal fusion from L1-S1 and provides kinematic data after surgery, according to a news release. The data will help remotely monitor progression of fusion and detect any instability, partial fusion or nonfusion.
Breakthrough device designation will expedite the process to FDA 510(k) clearance and market authorization.
The Canturio spine device collects data for at least 10 years. The data is pooled across the patient population to allow physicians to rank patient performance compared to peers in the same age group, gender and time since surgery.