Updated: Dec 28, 2020
By: Walter Eisner
On December 8, 2020, San Diego-based Carlsmed, Inc. announced its aprevo™️ patient-specific interbody devices were the first devices ever to receive the FDA Breakthrough Device Designation AND 510(k) clearance. The devices are intervertebral body fusion devices indicated to treat adult spinal deformity.
Getting a Breakthrough Device Designation from the FDA is a big deal towards getting your product through regulatory and payment mazes. The designation is the FDA's way of saying the device can provide an improved standard of care and guarantees national coverage from the Centers for Medicare & Medicaid Services (CMS) for the first four years after market clearance.