CurveBeam AI (ASX: CVB) announced that China’s National Medical Products Administration (NMPA) has approved its weight-bearing CT scanner, HiRise™. The approval, announced on 13 October 2026, came one day after CVB securities were temporarily suspended from trading on the ASX at the company's request. Trading resumed after the announcement.

CurveBeam AI described approval as a major milestone, moving the company from product development towards commercialisation in one of the world’s largest medical device markets. The company combines specialised CT imaging with AI-powered clinical assessment software delivered through a software-as-a-service (SaaS) model to help healthcare professionals manage musculoskeletal conditions.

Technology and Product

CurveBeam AI’s flagship product, HiRise™, uses weight-bearing CT imaging to provide a clinical perspective that conventional CT or MRI scans may not capture. This technology allows clinicians to assess patients’ musculoskeletal structures under natural weight-bearing conditions. HiRise™ integrates AI-powered software and a software-as-a-service (SaaS) model to support clinical assessment and musculoskeletal disease management.

CurveBeam AI currently employs more than 70 people and operates internationally. Its headquarters, intellectual property (IP) ownership, and AI division are based in Melbourne, Australia, while its global operations office is in Hatfield, Pennsylvania, United States.

In September 2026, CVB received FDA 510(k) clearance for BoneVue, its CT-based bone mineral density technology, marking another regulatory milestone for the company.

China Strategy and Partnership

CurveBeam AI’s entry into China is part of its long-term growth strategy and is supported by 10-year agreements with Shandong WeiYing Intelligent Medical Technology Co., Ltd. The partnership involves a joint venture linked to WEGO Orthopaedics, a major Chinese orthopaedic medical device supplier. HiRise™ received NMPA approval ahead of expectations, allowing commercial sales to commence and creating a pathway for marketing and distribution across Greater China.

Beyond product sales, the partnership includes plans for local manufacturing, supply chain optimisation and long-term royalty income. Under the agreements, WeiYing will handle marketing, distribution, and manufacturing, while CurveBeam AI will benefit from royalties on sales of locally manufactured scanners. This arrangement could support expansion in a major medical device market while helping manage production costs over time.

Financial Position and Share Market Developments

Alongside its commercial progress, CurveBeam AI announced several financial developments. Following NMPA approval, a funding commitment under its partnership agreement was triggered, and its Chinese partner committed to investing A$1 million in CVB shares at A$0.405 per share.

Following the NMPA approval announcement on 13 October 2026, CurveBeam AI shares rose by approximately 35%, closing at A$0.03, according to StockLight.

Separately, the company completed an issue of 12,222,223 new ordinary shares at A$0.018 per share under a Shortfall Overflow Placement. It also issued five million broker options with an exercise price of A$0.04 and an expiry date in 2027, as disclosed in a separate ASX announcement.

CurveBeam AI lodged a cleansing notice to meet disclosure requirements related to the on-sale of newly issued shares. This notice does not itself represent an additional capital raising. CVB remains a growth-stage company, and investors should consider potential share price volatility and associated investment risks.

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Conclusion

The commercial impact of HiRise™ approval will depend on adoption in China, execution of local manufacturing plans, and demand for CurveBeam AI’s product portfolio. Investors will monitor upcoming operational and financial reports for evidence of commercial uptake and progress towards these objectives.