Project Velocity: From RTA to Clearance in 90 Days

Challenge

A promising AI-diagnostic startup received a 'Refuse to Accept' (RTA) notice due to fragmented testing data and an unclear narrative around their novel technology. Their initial submission lacked the cohesive evidence required by the FDA.

Solution

Leanabl was brought in for emergency remediation. We immediately restructured the submission, creating a compelling narrative that contextualized their AI's performance. Our team consolidated the disparate software validation documents into a single, coherent package and drafted a clear, scientifically-backed response to the agency's anticipated AI-related questions.

Outcome

The revised 510(k) was submitted and achieved FDA clearance in under 90 days, with zero additional questions from the reviewer. The client avoided a protracted and costly deficiency letter process, enabling them to proceed with their Series A funding round on schedule.