Apex AI is full hands on deck preparing our KFDA application.
For AI in healthcare, regulatory clearance is the bridge between research and real-world patient impact. In Korea, that means SaMD (Software as a Medical Device) approval.
The process is strict for good reason. To pass, you need:
- Clear intended use and risk classification
- ISO-aligned quality systems (QMS, risk management, cybersecurity)
- Full traceability across model training, validation, and deployment
- Analytical clinical validation showing real-world safety & effectiveness
Every step is documented, reviewed, and stress-tested.
What we’ve done so far:
- Met with Korea Univ. Ansan Hospital to design upcoming clinical trials for AI-powered GI cancer detection.
- Locked in the SaMD roadmap with Ajou University Hospital’s Medical-Device Support Center, aligning validation and submission timelines.
- Secured head-to-head evaluations at Ajou (#7 in Korea) and Inha (#13) University Hospitals to strengthen evidence.
- Represented Apex AI at the 2025 Medical Device Development Program briefing, aligning with Korea’s updated AI-medical-device regulations and ISO mapping, positioning us for both KFDA and future FDA filings.
- Froze the model for submission, mapped data provenance from 1M endoscopy images, and validated annotation quality with leading GI specialists.
What comes next:
- Clinical validation studies with top hospitals to prove performance vs. current standards.
- Finalize the SaMD technical dossier (software architecture, risk files, cybersecurity, UX, labeling).
- Submit to KFDA, respond to technical queries, and move toward hospital deployment.
KFDA approval isn’t a milestone for Apex AI alone. It’s a step toward making early, accurate cancer detection available in everyday clinical practice.