An AI-powered software-as-a-medical-device simplifies radiation therapy dose planning for head and neck cancers.
This clearance represents a major step forward in our mission to bring innovative and clinically impactful solutions to the healthcare industry.”— Jim HavelkaHOUSTON, TX, UNITED STATES, July 15, 2026 /EINPresswire.com/ — InformAI, Inc., a frontrunner in cutting-edge medical technology, is pleased to announce it has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) to bring to market an AI-driven radiation therapy dose planning system called RadOncAI™. This clinician co-pilot, a software-as-a-medical-device, leverages artificial intelligence (AI) to refine the critical phase of radiation dose planning for individuals with head and neck cancers.
RadOncAI facilitates AI-powered radiation therapy by producing an enhanced dose plan that precisely targets tumors while reducing radiation exposure to nearby healthy tissue. This achievement represents a significant leap forward in the growth and accessibility of the InformAI suite of AI healthcare tools. With this FDA clearance, the product has met rigorous benchmarks for safety and effectiveness, proving its capacity to provide real advantages to healthcare professionals and patients. The product’s development included clinical research testing on a study group comprising more than 900 patients.
This approval enables InformAI to market and sell the product across the United States.
“We are thrilled to receive 510(k) clearance for RadOncAI,” stated CEO and Founder Jim Havelka. “This clearance represents a major step forward in our mission to bring innovative and clinically impactful solutions to the healthcare industry. We believe RadOncAI will assist radiation oncologists in generating quality dose plans more efficiently.”
The RadOncAI system incorporates InformAI’s proprietary intellectual property, along with licensed IP from the University of Texas Southwestern Medical Center (UTSW). InformAI further expresses gratitude to the Cancer Prevention and Research Initiative of Texas (CPRIT) for funding the DP220063 grant, which supports the RadOncAI product development.
About InformAI
InformAI is a technology firm committed to advancing healthcare via AI-enabled clinical applications. The organization specializes in crafting sophisticated products for oncology and diagnostic imaging aimed at enhancing patient results. InformAI was established on the principle that AI can drive a transformative shift in healthcare, employing predictive analytics to help clinicians diagnose medical conditions and refine patient treatment strategies.
Jackie Coleman
InformAI, Inc.
jcoleman@informai.com
