Madison-based RadUnity Corp. has received FDA 510(k) clearance for its medical imaging software platform.
The startup can now legally market its Class II medical device while subject to the rules and regulations of the Federal Food, Drug and Cosmetic Act.
Medical imaging varies greatly within the health care industry. When CT images are reconstructed differently from scan to scan, it makes it harder for radiologists to figure out if changes in a patient’s disease or healing process are real, or the result of a different CT scanner being used.
RadUnity’s software-as-a-service platform controls the creation of images, making sure physicians have a consistent look and feel for imaging data for every patient.
RadUnity, a University of Wisconsin-Madison spinoff, collaborated with Innolitics and Asher-Orion Group LLC to validate its product with the FDA by collecting data across multiple sites.
“With this clearance, we’ve made a significant leap toward turning an academic concept into a practical clinical solution. This milestone will help us secure additional funding and expand our team. It brings us closer to fulfilling my goal of providing a solution that the community will embrace and use to improve patient care,” said Tim Szczykutowicz, founder of RadUnity.
While RadUnity can now legally market its device, the startup plans to develop additional product features before fully bringing its product to the masses.
“Depending on the nature of these developments, the company may need to work with the FDA again by sharing the changes to the existing device,” said a spokesperson for the company Monday.
