The software is designed to assist clinicians by identifying key anatomical structures in real time during ultrasound-guided regional anesthesia.
SmartAlpha has received 510(k) clearance from the US Food and Drug Administration (FDA) for Nerveblox, an artificial intelligence (AI) software solution designed to assist physicians in performing ultrasound-guided regional anesthesia, also known as nerve blocks. The clearance allows the company to launch its technology in the US healthcare market.
Nerve block procedures are used to manage surgical and chronic pain by injecting anesthetics into a localized region. When performed under ultrasound imaging, these procedures can support effective pain management, potentially leading to faster recovery and a decreased need for opioids, according to the company. The Nerveblox software assists healthcare professionals by detecting and highlighting up to 50 key anatomical structures in real time during an ultrasound scan. It is applicable to a broad range of procedures, including those for cesarean sections, breast surgery, knee and shoulder procedures, and pain relief for injuries.
AI to Aid in Procedural Accuracy
The technology is intended to help improve the precision of interventional ultrasound and support the wider adoption of ultrasound-guided pain relief strategies.
“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,” says Gary Schwartz, MD, director of AABP Integrative Pain Care and Wellness, in a release. “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 focusing on commercialization in new markets and building partnerships to distribute the Nerveblox solution. The software was also granted regulatory approvals in Europe, the UK, and Australia earlier in 2025.
“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,” says SmartAlpha co-founder Utku Kaya in a release.
Photo caption: Nerveblox
Photo credit: SmartAlpha
