CardioScan AI is supported by rigorous clinical evidence from a multi-center Phase 2 prospective trial across four leading medical institutions.
| Protocol | CLX-CS-2024-001 |
| Design | Multi-center, prospective, single-arm |
| Sites | 4 centers |
| Primary Endpoint | Sensitivity & specificity vs. standard ECG interpretation |
| Expected Readout | Q3 2025 |
Interim results from ongoing Phase 2 trial. Final results pending study completion.
Boston, MA
PI: Dr. Elena Vasquez
Chicago, IL
PI: Dr. Amara Singh
Los Angeles, CA
PI: Dr. James Liu
Cleveland, OH
PI: Dr. Rachel Patel
CardioScan AI is progressing through the FDA 510(k) clearance pathway.
Quality management system certification — 2023
Security controls validated by independent auditor — 2024
Formal submission to FDA — April 2025
Anticipated 510(k) clearance — Q4 2025
Principal Investigator & CEO
Board-certified cardiologist and former attending physician at Massachusetts General Hospital. Dr. Vasquez brings over 15 years of clinical cardiology experience to CardioScan AI, having treated thousands of patients with complex cardiac conditions before co-founding Cardiolytix in 2019.
“Deep Learning for Automated 12-Lead ECG Interpretation: A Multi-Center Validation Study”
Vasquez E, Chen M, et al. — American Heart Association Scientific Sessions 2024 (Poster)
“CardioScan AI: Interim Analysis of a Prospective Phase 2 Trial for AI-Assisted Cardiac Diagnostics”
Vasquez E, Singh A, Liu J, Patel R. — Heart Rhythm 2025 (Oral Presentation)
“Real-World Performance of AI-Based ECG Screening in Community Health Systems”
Whitfield J, Torres D, Vasquez E. — ACC.25 (Poster)