Medical imaging data management and analytics platform developer Flywheel is expanding its portfolio with Flywheel Validated, a software tool designed for use in clinical trials to streamline compliant imaging workflows and improve access and management of data and medical images.
The company said that Flywheel Validated provides guided data uploads for site contributors in multicenter studies, and supports validated imaging reads and quality control.
Flywheel Validated also has audit trail, project locking, and e-signature capabilities to meet regulatory submission requirements.
It is compliant with 21 CFR Part 11 to assist organizations conducting regulated or near-regulated trials and AI model development accelerate time-to-decision and time-to-market, Flywheel added.
![A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/07/2026-07-14-radiology-mammogram-ai-auto-bias.H0bYO8QlWs.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
