AI-based SaMD streamlines dose planning for head & neck cancer radiotherapy
“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 obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) to commercialize an AI-powered radiation therapy dose planning system, RadOncAI™. This clinician co-pilot software-as-a-medical-device leverages artificial intelligence (AI) to refine the essential stage 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 reducing radiation exposure to surrounding healthy tissue. This achievement represents a notable leap forward in the evolution and accessibility of the InformAI suite of AI healthcare tools. Through this FDA clearance, the product has satisfied stringent safety and efficacy benchmarks, proving its capacity to deliver substantial advantages to both medical practitioners and patients. The creation of this product involved clinical research testing on a cohort of more than 900 patients.
This clearance enables InformAI to market and distribute 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 offering incorporates InformAI’s proprietary intellectual property along with 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 funding grant DP220063, which backs the RadOncAI product development.
About InformAI
InformAI is a technology firm committed to advancing healthcare through AI-driven clinical solutions. The company specializes in developing sophisticated products for oncology and diagnostic imaging aimed at improving patient outcomes. InformAI was established on the principle that AI can usher in a paradigm shift in healthcare by employing predictive analytics to aid clinicians in diagnosing medical conditions and refining patient treatment strategies.
Jackie Coleman
InformAI, Inc.
jcoleman@informai.com
