Nerveblox AI Software Gains FDA Clearance for Regional Anesthesia

August 19, 2025
SmartAlpha's Nerveblox, an AI tool for ultrasound-guided regional anesthesia, has received FDA 510(k) clearance, enabling its launch in the U.S. healthcare market.

SmartAlpha's Nerveblox, an AI software designed to assist in ultrasound-guided regional anesthesia, has received FDA 510(k) clearance, announced in a press release. This clearance allows the company to introduce its technology to the U.S. healthcare market.

Nerveblox aids healthcare professionals by detecting and highlighting 50 key anatomical structures in real-time during ultrasound scanning for nerve block procedures. These procedures are used to manage surgical and chronic pain by numbing localized regions, potentially reducing the need for opioids and leading to faster recovery times.

The software supports a wide range of clinical practices, including cesarean sections, breast surgery, and knee and shoulder procedures. SmartAlpha, a Türkiye-based startup, is now focused on expanding its commercialization efforts and building partnerships to ensure the global reach of Nerveblox. The software has also received regulatory approvals in Europe, the UK, and Australia earlier this year.

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