Minneapolis, MN — December 2, 2025 — Flywheel, the leading medical imaging data management and analysis platform, today announced the launch of Flywheel Validated, a solution designed to streamline compliant imaging workflows and improve data access for clinical trial stakeholders. Flywheel Validated (a specific version of Flywheel’s core technology platform) is compliant with 21 CFR Part 11, helping organizations conducting regulated or near-regulated trials and AI model development accelerate time-to-decision and time-to-market. The goal is to empower life sciences organizations and researchers by providing a faster pathway to their imaging data — ultimately leading to clearer decisions and higher confidence throughout the trial or project lifecycle.
Flywheel Validated unlocks a critical bottleneck in clinical research by helping pharmaceutical sponsors, reading centers, CROs, and academic medical centers access and analyze their clinical trial imaging data earlier and more efficiently — while being designed to maintain regulatory compliance and trial integrity. This purpose-built solution expands on the existing Flywheel Research platform that accelerates imaging data aggregation, curation, and analysis via automated processing pipelines. It provides a guided data upload experience for site contributors in multicenter studies and supports human-in-the-loop workflows, including validated imaging reads and quality control. The Flywheel Validated offering also includes audit trail, project locking, and e-signature capabilities, ensuring users can confidently leverage auditable results for regulatory submission.
“Our Flywheel Validated solution addresses long-standing barriers in clinical trials: the slow, fragmented access to high-quality, compliant data,” said Shelby Wyatt, Chief Product Officer at Flywheel. “With Flywheel Validated, Pharma sponsors can glean insights and adjust trials from imaging data earlier, while reading centers streamline their operations from guided uploads, automated checks, and structured validated reads in a unified platform. In doing so, we’re enabling organizations across the entire clinical trial ecosystem to unlock clearer, earlier findings — helping to avoid wasted time and money and ultimately improving trial outcomes.”
Flywheel will showcase the Flywheel Validated solution in the upcoming GEN webinar on December 11, 2025, titled “Accelerating Clinical Decisions Through Faster Access to Imaging Data.” For more information or to request a demo, visit flywheel.io.
About Flywheel
Flywheel offers the leading medical imaging platform that empowers healthcare innovation by streamlining imaging data management, automating research workflows and preparing data for AI development. Flywheel’s comprehensive solution is designed to allow pharmaceutical and biotechnology companies, academic medical centers, AI developers and medical device manufacturers to realize optimum value out of their imaging data assets. For more information on our mission and products, visit www.flywheel.io or follow us on LinkedIn.