Turkey-based biomedical technology firm SmartAlpha has received the US Food and Drug Administration (FDA) clearance for its artificial intelligence (AI)-driven software, Nerveblox.
Nerveblox assists in ultrasound-guided regional anaesthesia, known as nerve block procedures, improving pain management for surgical and chronic pain patients.
The FDA approval allows SmartAlpha to launch Nerveblox in the US healthcare sector.
SmartAlpha co-founder Utku Kaya said: “Ultrasound guidance is increasingly used for nerve blocks since it maximises block success and minimises risk of complications.
“SmartAlpha is supporting this adoption, and with this clearance, we have taken a significant step forward in SmartAlpha’s mission of delivering AI solutions that assist healthcare professionals worldwide in performing ultrasound imaging with greater ease and confidence.”
Nerveblox is designed to identify and highlight 50 key anatomical structures across 12 regions, offering real-time guidance during ultrasound scans for nerve block procedures.
The technology supports several clinical applications, including cesarean sections, breast surgeries, and knee procedures, potentially reducing recovery times and opioid use.
The software enhances ultrasound image interpretation by auto-labelling critical anatomical landmarks, facilitating precise nerve block procedures.
SmartAlpha aims to expand Nerveblox’s availability worldwide, with regulatory approvals already secured in Europe, the UK, and Australia.
AABP Integrative Pain Care and Wellness director Gary Schwartz said: “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.
“Having utilised the Nerveblox technology at our research centre and contributed to the pivotal trial, I have seen firsthand the potential of this technology to advance precision and safety of interventional ultrasound.”
