SmartAlpha Receives Second FDA Clearance Within a Year for MSK Go™, Its Musculoskeletal Ultrasound AI

• MSK Go™ is an AI-powered software solution designed by SmartAlpha that assists clinicians in performing musculoskeletal (MSK) ultrasound examinations, supporting the assessment of joints, tendons, muscles, and nerves at the point of care.
• More than an answer to today's expertise gap, MSK Go is designed as an intelligence layer for the next generation of ultrasound users — whether human or robotic.

MSK Go™, an AI software solution by SmartAlpha designed to assist clinicians in interpreting musculoskeletal ultrasound images in real time during the scan, has received U.S. Food and Drug Administration (FDA) 510(k) clearance. The clearance marks SmartAlpha's second FDA-cleared ultrasound AI product within one year, following the clearance of Nerveblox™ in 2025, and further establishes the company's presence in the U.S. healthcare market.

As the population ages and the strain on health systems grows, musculoskeletal conditions have become one of the heaviest burdens in U.S. healthcare — affecting more than one in three Americans and ranking among the largest drivers of healthcare expenditures. Demand for musculoskeletal imaging is rising accordingly, yet a persistent shortage of trained ultrasound experts and sonographers limits access to ultrasound — a modality that can deliver imaging at lower cost, faster, and right at the point of care.

MSK Go addresses this challenge with SmartAlpha's broad-coverage anatomy awareness solution: rather than recognizing anatomy only in a handful of predefined scanning windows, the software continuously interprets the ultrasound image as the clinician scans, identifying and highlighting relevant structures — bones, tendons, muscles, nerves, and vessels — wherever the probe is placed across the covered regions. This allows the software to support real-world scanning behavior, with coverage supporting common examinations from carpal tunnel to Achilles tendon to rotator cuff — 120 structures across the body.

MSK Go is more than an immediate answer to today's expertise gap — it ushers in the next generation of AI in musculoskeletal ultrasound. Its real-time, edge-ready AI is designed as an intelligence layer for use by human or robotic systems.

Commenting on the new product, SmartAlpha co-founder and CEO Utku Kaya stated: "Right after bringing our first solution Nerveblox to clinics globally, we are now announcing the availability of MSK Go for musculoskeletal ultrasound imaging in the United States. But MSK Go also represents something bigger in our vision: an intelligence layer for ultrasound that gives every intelligent healthcare worker, human or robotic, the perception needed to perform ultrasound like experts. Bringing our second cleared solution to market in such a short time shows how determined the SmartAlpha team is to deliver on our vision and ultimately on better patient care."

Following the clearance, SmartAlpha will focus on commercializing MSK Go in the U.S. through its existing distribution partnerships with leading medical imaging vendors, while pursuing regulatory approvals in additional markets.

Disclaimer

MSK Go™ is not yet available for sale in all regions worldwide. In regions where MSK Go™ is commercially available, it is intended solely for use by qualified healthcare professionals who are licensed to perform musculoskeletal ultrasound examinations and have been trained in the use of the software, in accordance with local regulations.