United Imaging Intelligence partnered with MCRA, an IQVIA business, to accelerate FDA clearance for AI-based stroke triage software. Regulatory approval for Computer Aided Triage solutions is typically complex and time-consuming, often requiring multiple review cycles. MCRA delivered a tailored 510(k) strategy, precise documentation, clinical validation support, and proactive FDA engagement. Leveraging former FDA experts and cross-functional collaboration, the team achieved clearance in under 60 days with zero deficiencies. The streamlined submission reduced time to market, stayed under budget, and set a new benchmark for efficient, compliant AI regulatory pathways.

Join for free to read