FDA Grants Onc.AI Breakthrough Device Designation for "Serial CTRS" in Early Mortality Risk Assessment

Onc.AI, a digital health company specialising in AI-driven oncology clinical management solutions, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Serial CT Response Score (Serial CTRS) AI model.

This AI-based prognostic tool uses deep learning to analyse CT scans and classify patients with metastatic non-small cell lung cancer (NSCLC) into high- or low-mortality risk categories.

The recognition highlights the potential of Onc.AI’s imaging AI models to provide early and automated risk assessment, supporting clinicians in optimising treatment decisions and patient monitoring.

As a validated prognostic tool, Serial CTRS is expected to aid oncologists by providing automated risk stratification using routinely collected diagnostic imaging scans. By integrating AI-driven insights into clinical workflows, it aims to refine treatment strategies and improve patient outcomes.

In collaboration with partners, including Flatiron Health, Onc.AI has leveraged high-quality, curated real-world data to develop and validate regulatory-grade AI models for clinical use. This ongoing partnership is expected to facilitate further regulatory milestones and advancements in oncology AI solutions.

Beyond its clinical applications, Serial CTRS shows promise in advancing oncology drug development. It has demonstrated superior performance compared to RECIST in predicting overall survival, offering enhanced decision-making capabilities for clinical trials and therapeutic development.

Its ability to deliver robust patient insights could play a key role in shaping the future of early-phase trials and oncology research.

The AI model aims to make a significant impact on both clinical practice and the advancement of new cancer treatments.