An AI-powered software-as-a-medical-device enhances the efficiency of 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 that it has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) to commercialize an AI-driven radiation therapy dose planning tool, RadOncAI™. This clinician co-pilot, categorized as software-as-a-medical-device, leverages artificial intelligence (AI) to refine the crucial phase of radiation dose planning for patients with head and neck cancers.
RadOncAI facilitates AI-powered radiation therapy by producing an optimized dose plan that zeroes in on tumors while limiting radiation exposure to surrounding healthy tissues. This achievement signifies a notable leap forward in the creation and accessibility of InformAI’s suite of AI healthcare applications. With this FDA clearance, the product has satisfied rigorous benchmarks for safety and effectiveness, confirming its capacity to provide substantial advantages to both healthcare professionals and patients. The product’s development entailed clinical research testing on a cohort exceeding 900 patients.
This clearance authorizes InformAI to market and distribute the product throughout the United States.
“We are thrilled to receive 510(k) clearance for RadOncAI,” said 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 solution incorporates proprietary intellectual property from InformAI as well as licensed IP from the University of Texas Southwestern Medical Center (UTSW). InformAI also expresses gratitude to the Cancer Prevention and Research Initiative of Texas (CPRIT) for supporting the DP220063 grant, which funds the development of the RadOncAI product.
About InformAI
InformAI operates as a technology firm dedicated to progressing healthcare via AI-powered clinical applications. The organization focuses on creating sophisticated products for oncology and diagnostic imaging aimed at enhancing patient outcomes. InformAI was established on the principle that AI can drive a paradigm shift in healthcare by employing predictive analytics to aid clinicians in diagnosing medical conditions and refining patient treatment regimens.
Jackie Coleman
InformAI, Inc.
jcoleman@informai.com
