Empowering FDA Clearance of United Imaging Intelligence Technology in Under 60 Days

MCRA’s AI & Imaging Center team collaborated with its Clinical and Regulatory Affairs divisions to deliver accelerated FDA clearance of a groundbreaking radiology technology from United Imaging Intelligence. MCRA’s operational expertise and seamless integration ensured the study had zero deficiencies — resulting in the approval of their client’s uAI Easy Triage ICH software in under 60 days.

uAI Easy Triage ICH uses AI technology to quickly identify and flag potential intracranial hemorrhages in CT scans. This intelligent alert system helps healthcare professionals prioritize treatment for stroke patients -- when every moment counts. 

United Imaging Intelligence, a global leader in advanced medical imaging and radiotherapy equipment, retained MCRA's AI & Imaging Center to lead their device performance study with the goal of receiving an expeditious 510(k) clearance. 

Achieving FDA clearance of Computer Aided Triage (CADt) technology is particularly challenging. Due to their targeted application, these submissions typically involve multiple rounds of review phases to address key concerns -- and can take as long as 100 days. Companies rarely receive clearance on their first submissions, and it's even less common to do so without deficiencies. 

United Imaging Intelligence relied on MCRA's deep FDA insight for all aspects of their study. Bringing together study design, protocol development, data sourcing, biostatistics analysis, report generation and knowledgeable expertise, MCRA played a crucial role in the study's efficiency and accelerated their FDA clearance. 

Drawing on their extensive knowledge of all aspects of FDA clearance, MCRA's cross-functional team ensured United Imaging Intelligence received their 510(k) clearance for uAI Easy Triage ICH in less than 60 days and with zero deficiencies -- all while remaining under budget.