Nerveblox, the Ultrasound AI for Regional Anesthesia, Receives FDA Clearance

, /PRNewswire/ — Nerveblox, an AI software solution by SmartAlpha, designed to assist physicians in using ultrasound while administering regional anesthesia procedures commonly known as ‘nerve blocks’, has received U.S. Food and Drug Administration (FDA) 510(k) clearance. This clearance opens the door for SmartAlpha to launch its technology to the U.S. healthcare market at a time when AI’s role in medicine is more relevant than ever.

Nerve block procedures help physicians numb a localized region by injecting 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 assists healthcare professionals by identifying and displaying anatomy in real time during ultrasound scanning for nerve block procedures. It spans a broad range of nerve block procedures 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, MD, FASA, FASRA, Director of AABP Integrative Pain Care and Wellness. “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.”

Commenting on the FDA clearance, SmartAlpha co-founder Utku Kaya stated, “Ultrasound guidance is increasingly used for nerve blocks since it maximizes block success and minimizes risk of complications. 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 now focused on scaling commercialization in new markets and building strong partnerships to ensure the Nerveblox solution effectively reaches healthcare providers around the world. Nerveblox has also been granted regulatory approvals in Europe, the UK and Australia earlier in 2025.

About SmartAlpha:

SmartAlpha is a Türkiye-based startup with growing operations in the U.S. and Europe, dedicated to expanding the use of ultrasound by delivering advanced medical skills through clinically proven and regulatory-cleared ultrasound AI. Today, the company operates with a team of 20 engineers and clinical specialists, working in close collaboration with world-renowned physician advisors, and partners with leading global medical imaging vendors through whom its products are distributed to markets worldwide.

Disclaimer:

Nerveblox is not available for sale in all regions. In regions where Nerveblox is commercially available, it is intended solely for use by qualified healthcare professionals who are licensed to perform ultrasound-guided regional anesthesia procedures and have been trained in the use of the software, in accordance with local regulations.

SOURCE SmartAlpha