AI-powered SaMD streamlines radiation therapy dose planning for head & 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 confirm it has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the commercialization of an AI-driven radiation therapy dose planning system, RadOncAI™. This clinician co-pilot software-as-a-medical-device leverages artificial intelligence (AI) to refine the critical phase of radiation dose planning for individuals with head & neck cancers.
RadOncAI facilitates AI-guided radiation therapy by producing an optimized dose plan that precisely targets tumors while limiting radiation exposure to surrounding healthy tissue. This achievement represents a considerable leap forward in the evolution and accessibility of InformAI’s suite of AI healthcare offerings. Following this FDA clearance, the product has satisfied rigorous benchmarks for safety and effectiveness, affirming its capacity to provide substantial advantages for both medical professionals and patients. The product’s development involved clinical research testing on a patient group exceeding 900 individuals.
This clearance authorizes InformAI to market and distribute the product across the United States.
“We are delighted to have obtained 510(k) clearance for RadOncAI,” stated CEO and Founder Jim Havelka. “This clearance marks a substantial milestone in our mission to deliver innovative, clinically meaningful solutions to the healthcare sector. We are confident that RadOncAI will help radiation oncologists create high-quality dose plans with greater efficiency.”
The RadOncAI product 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 backs the RadOncAI product
development.
About InformAI
InformAI is a technology firm devoted to progressing healthcare via AI-enabled clinical tools. We focus on creating advanced products for oncology and diagnostic imaging to enhance patient outcomes. InformAI was established on the principle that AI can drive a paradigm shift in healthcare, employing predictive analytics to support clinicians in diagnosing medical conditions and refining patient treatment plans.
Jackie Coleman
InformAI, Inc.
jcoleman@informai.com
