Case Study: Dilon Technology secures FDA submission on time with ArcaScience's AI-assisted benefit-risk assessment

Dilon Technology secures FDA submission in under 1 month with ArcaScience

Dilon Technology, a medical device company, faced the challenge of creating a fully auditable benefit-risk assessment (BRA) for a regulatory submission to the FDA. Traditional expert-led methods were too slow and could not deliver a submission-ready dossier at the speed required by regulatory timelines. They turned to ArcaScience and its AI-Assisted Benefit-Risk Assessment service to solve this problem.

ArcaScience implemented its structured Benefit-Risk regulatory-qualified framework, executing a 6-step methodology on its platform. This solution systematically identified, extracted, and synthesized evidence from thousands of articles, providing full transparency and 100% data traceability. As a result, Dilon Technology secured its FDA submission within the required timeline for a hemostatic device indication expansion. The project achieved an 80% cost reduction compared to traditional methods and received no quality concerns or additional information requests from the regulator.

Dilon Technology