EverFortune.AI (長佳智能) announced yesterday that its AI-powered medical software, the Radiotherapy Organ Auto-Contouring System (Seg Pro V3), has been granted US FDA 510(k) clearance. Notably, it is the first product globally in the "Radiotherapy Image Processing Software" (QKB) category to be approved under the FDA’s Predetermined Change Control Plans (PCCP).

• Clinical Utility: Seg Pro V3 automates the contouring of 182 organs-at-risk (OARs) across the head, neck, thorax, abdomen, and pelvis using CT or MRI imagery, significantly streamlining the radiotherapy planning workflow.
• The PCCP Advantage: General Manager Dr. Li Yu-zheng noted that traditional SaMD (Software as a Medical Device) faces rigid update restrictions post-market. The PCCP framework allows for controlled, pre-validated model re-training and updates. This enables the AI to adapt to site-specific clinical needs while maintaining stringent safety and reliability standards.
• Global Footprint: Following its Taiwan TFDA approval in December 2025 (which also included a PCCP), the company now holds 54 global regulatory clearances, including 14 from the US FDA and 22 from Taiwan TFDA, cementing its leadership in the digital health sector.

Resource: 長佳智能Seg Pro V3 全球首例通過放射治療美國FDA PCCP