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[Apex AI @Official_ApexAI]

Apex AI CEO Sung Kim shares an update on our KFDA application process.

Apex AI is officially going for Class III approval, the highest category for life-threatening diseases like cancer. It means stricter standards, deeper documentation, and full clinical trials, but it’s the right path for a technology built to save lives.

$APEX Saves Lives.

[Apex AI @Official_ApexAI]

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.

[Apex AI @Official_ApexAI]

ICM has an exit problem.

If a company gets acquired, what happens to the token?
Does it disappear? Does it still mean anything?

At Apex AI, we plan for that.

We believe the future of Internet Capital Markets is a road to ownership of real companies, built through compliant, on‑chain SPVs. When there’s a liquidity event, proceeds flow to on‑chain SPV holders.

And $APEX will play a major role in all of this.

Stay tuned. $APEX saves lives.

[Apex AI @Official_ApexAI]

We met with Korea University Ansan Hospital to discuss upcoming clinical trials for AI-driven cancer detection. Turning years of research and over 1M images into real-world validation starts here.

$APEX Saves Lives.

[Apex AI @Official_ApexAI]

Alpha is live 👀

$APEX perps trading coming soon!

[Apex AI @Official_ApexAI]

August pushed Apex AI further onto the global stage.

From Korea’s first SaMD framework to new connections in Boston and Harvard, every step brings us closer to real-time deployment of life-saving AI.

$APEX will carry this mission forward.

[Apex AI @Official_ApexAI]

During two weeks in the US, @Sung_W_Kim met with Harvard Medical School professors and med-tech leaders in Boston.

https://t.co/DvQPwDP7EB

[Apex AI @Official_ApexAI]

August was a pivotal month for Apex AI.

From interviews and regulatory milestones in Korea to US expansion talks in Boston and Harvard Med, here’s everything you may have missed.

[Apex AI @Official_ApexAI]

Join us this Saturday for an AMA with Apex AI’s CEO @Sung_W_Kim!

We’ll dive into insights on the KFDA and FDA application process, and deeper insights on the future of Apex AI.

Saturday, September 6th @ 13:00 UTC

https://t.co/REzNzmLvJS

[Apex AI @Official_ApexAI]

Join us live with Apex AI’s CEO @Sung_W_Kim in 30 mins!

https://t.co/REzNzmKXUk

[Apex AI @Official_ApexAI]

https://t.co/REzNzmKXUk

[Apex AI @Official_ApexAI]

Starting now

https://t.co/2TPaF2E0lk

[Apex AI @Official_ApexAI]

Our CEO @Sung_W_Kim sat down in Boston to share insights as Apex AI gears up for U.S. expansion

$APEX Saves Lives

[Apex AI @Official_ApexAI]

July set the stage for the next chapter: ICM Phase 2 is here, transforming investment access, driving real-world innovation, and empowering $APEX to save lives.

Together, we're building the future.

[Apex AI @Official_ApexAI]

Patent officially registered: Our internal tool automating false-positive detection in medical AI training is now patented and registered, significantly cutting development time and costs.

https://t.co/Ey7ud8fnBT

[Apex AI @Official_ApexAI]

July was nonstop at Apex AI.

From groundbreaking steps in life-saving AI tech to major developments in Internet Capital Markets, here’s every key moment from July ↓

[David @DavidB_333]

internet capital markets

[D-Day @Official_DDay]

Internet Capital Markets.

Join the movement.