Alphatec Gains FDA Clearance for SafeOp Neuromonitoring

By Julie A. Vetalice

Alphatec received FDA 510(k) clearance to market automated SafeOp neuromonitoring for use in real-time intra-op nerve location and health assessment. The clearance expands the application with additional advanced algorithms for electromyography (EMG).

SafeOp employs somatosensory evoked potential (SSEP) and EMG to assess functional health of the spinal cord and nerves and to test nerves for location, proximity and conduction, respectively. The technology has been successfully used in more than 1,000 surgeries to identify potential nerve injury from patient positioning. ATEC acquired SafeOp in 2018.

Full launch will occur within 1H19. Initially, ATEC will focus the system on minimally invasive lateral procedures, adding other surgical approaches over time. This represents the first offering from the company's Alpha Informatix™ platform.

Sources: Alphatec Holdings, Inc.; ORTHOWORLD Inc.

Product Labels: Surgical Navigation, Spinal Fusion

Tags: 510(k) Clearance, Regulatory