Axcellant partners with Prometheus MedTech.AI to accelerate AI-powered cardiac diagnostics

1. paź 27, 2025

We’re pleased to announce a strategic partnership between Axcellant and Prometheus MedTech.AI — a medtech startup developing AI-powered solutions for the early detection of congenital heart conditions.

This collaboration brings together Prometheus’s clinical innovation and Axcellant’s deep expertise in imaging-based trials, regulatory strategy, and Software as a Medical Device (SaMD) development.

Axcellant is providing end-to-end support for the Prometheus clinical program, including:

• Regulatory pathway planning and submission strategy
• Execution of a multi-site clinical trial, including Imaging Core Lab oversight
• Implementation of digital tools such as EDC, CTMS, and eTMF
• Final study reporting and preparation for FDA certification

A key milestone on the horizon is the formal FDA Q-Sub meeting — a pivotal step toward regulatory alignment and clinical validation.

This partnership reflects Axcellant’s continued focus on working with companies at the intersection of digital health, medical imaging, and clinical research. Together with Prometheus, we aim to advance how AI is clinically validated and integrated into real-world cardiology diagnostics.

We look forward to supporting this journey from concept to certification — and beyond.