FDA-Regulated AI / Healthcare
Penn Medicine / QRS
Quantiva partnered with Penn Medicine to bring a breakthrough AI medical device from research prototype to FDA-cleared commercial product, navigating one of the most demanding regulatory pathways in healthcare while cutting costs by more than half.
60%+
cost savings to FDA clearance
Challenge
Commercialize an AI prototype classified as FDA Class II, requiring continuous training, adaptive algorithms, and a full quality management system for 510(k) clearance.
Solution
Promoted prototype to commercial-grade cloud-hosted imaging service with QMS compliant to FDA design controls. Built scalable infrastructure for ongoing AI model training.
Result
FDA 510(k) clearance achieved within months. Over 60% cost reduction compared to traditional regulatory pathways. Scalable cloud infrastructure for continuous model updates.
Impact
First AI-powered auto-contouring tool cleared for radiation oncology treatment planning. Established a repeatable framework for FDA-regulated AI products.