SmartAlpha Earns FDA Clearance for AI Software Solution

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Nerveblox, an AI software solution developed by SmartAlpha that uses ultrasound to assist doctors during nerve block procedures.

Nerve blocks numb a localized region (through injected anesthetics) for managing both surgical and chronic pain. Performed under ultrasound imaging, nerve block procedures enable effective pain management that may lead to faster recovery, shorter hospital stays, and quicker return to normal activities while potentially decreasing the need for opioids.

With the ability to detect and highlight 50 key anatomical structures, Nerveblox software helps healthcare professionals identify and display anatomy in real time during ultrasound scanning for nerve block procedures. It spans a broad range of nerve blocks relevant to clinical practice from cesarean sections and breast surgery to knee and shoulder procedures, as well as pain relief for fractures and injuries.

“By harnessing AI, we can elevate procedural decision-making to enhance accuracy, and accelerate the adoption of ultrasound-guided pain relief strategies that improve patient outcomes,” said Dr. Gary Schwartz, M.D., director of AABP Integrative Pain Care and Wellness in Brooklyn, N.Y. “Having utilized the Nerveblox technology at our research center and contributed to the pivotal trial, I have seen firsthand the potential of this technology to advance the precision and safety of interventional ultrasound.”

SmartAlpha is now focused on scaling commercialization in new markets and building strong partnerships to ensure the Nerveblox solution reaches healthcare providers globally. Nerveblox was also granted regulatory approvals in Europe, the United Kingdom, and Australia earlier this year.

“Ultrasound guidance is increasingly used for nerve blocks since it maximizes block success and minimizes risk of complications,” SmartAlpha Co-Founder Utku Kaya stated. “SmartAlpha is supporting this adoption, and with this clearance, we have taken a significant step toward SmartAlpha’s mission of delivering AI solutions that assist healthcare professionals worldwide in performing ultrasound imaging with greater ease and confidence.”

SmartAlpha is a Türkiye-based startup with growing operations in the United States and Europe, striving to expand the use of ultrasound by delivering advanced medical skills through clinically proven and regulatory-cleared ultrasound AI. The company currently operates with a team of 20 engineers and clinical specialists, working in close collaboration with physician advisors, and partners with global medical imaging vendors through whom its products are distributed to markets worldwide.