From Concept to Clinical Practice: How Segmed Powered RadUnity’s Fast-Track to FDA Clearance
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Customer: RadUnity Corp.
Industry: Medical Imaging / HealthTech
Founder: Tim “Stick” Szczykutowicz, Ph.D.
Product: A harmonization platform for CT imaging data tailored for radiologists,
researchers, and AI applications
The Challenge
As RadUnity set out to build its Minimum Viable Product (MVP), a critical barrier stood in the way: access to a sufficiently diverse and representative dataset of CT scans. Their vision—to standardize harmonized imaging as a core utility within medical institutions—relied heavily on validating their platform with images from various manufacturers, sites, and patient demographics.
Manually sourcing this data would require RadUnity to negotiate with individual healthcare providers, navigate complex legal agreements, and invest significant time and resources into data aggregation. For a startup pushing toward FDA clearance and early clinical adoption, this was not just a bottleneck—it was a potential deal-breaker.
The Segmed Solution
Segmed provided RadUnity with a streamlined, end-to-end data access platform, allowing the team to quickly tap into a vast, diverse pool of de-identified CT imaging data sourced from multiple institutions and scanner manufacturers. With a single, simplified legal agreement, RadUnity was able to bypass the traditionally long and complex data acquisition process.
Segmed’s advanced querying capabilities also allowed RadUnity to zero in on specific clinical indications and findings, ensuring their dataset was not just diverse—but also clinically relevant to their validation needs.
“The ability to get data from multiple different manufacturers and practices in such a seamless manner with a very straightforward legal contract is the special sauce of working with Segmed. The ability to query on specific clinical indications and findings was more than I expected and definitely met our needs.”
— Tim “Stick” Szczykutowicz, Ph.D., Founder, RadUnity Corp.
The Impact
Segmed’s data platform became a critical enabler for RadUnity’s rapid MVP development. With quick access to high-quality, structured, de-identified medical imaging data from diverse population, RadUnity was able to:
- Accelerate their platform validation, testing their harmonization technology across a range of scanner types and imaging protocols.
- Streamline FDA submission, supported by a solid foundation of real-world imaging data from varied sources.
- Shorten time-to-clinic, helping bring their concept to practice faster and with greater confidence.
By partnering with Segmed, RadUnity moved from concept to clinical readiness significantly faster than would have been possible through traditional data acquisition methods.
Conclusion
For healthcare startups like RadUnity, innovation hinges not just on great ideas, but on execution—especially when regulatory pathways and clinical validation are involved. Segmed’s platform removed one of the biggest obstacles in RadUnity’s journey: access to diverse, high-quality medical imaging data. As a result, RadUnity could focus on what they do best: transforming the way radiologists and AI systems interact with CT imaging.
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About Tim Szczykutowicz, PhD
Dr. Tim Szczykutowicz is an internationally-known figure in the field of radiology. He is an associate professor in the Department of Radiology at the University of Wisconsin-Madison. With over a decade of experience in academic and clinical radiology, he authored the book "The CT Handbook: Optimizing Protocols for today's feature rich scanners", and has published more than 80 papers and 6 patents. Tim co-developed CT protocols that have been disseminated to thousands of practices around the world. Tim has consulted and advised six different medical imaging companies, assisted with product development, identified problems and solutions, and developed marketing strategies.
Follow Tim Szczykutowicz on LinkedIn.
About RadUnity
RadUnity Corp. is a start-up using technology developed at UW Madison based on IP owned by the Wisconsin Alumni Research Foundation (WARF) and invented by its founder, Tim “Stick” Szczykutowicz. RadUnity is a platform that presents harmonized images from diverse Computer Tomography (CT) data tailored for any radiologist, researcher, or AI tool. Our vision is to become a standard building block of any institution’s medical imaging informatics system, providing a platform of harmonization services to satisfy the needs of radiologists and the AI vendors that assist them.
Explore RadUnity website.
