Redefining Oncology Treatment Planning with Lumonus AI
Lumonus has developed two software productions, Lumonus Treatment Planning Automation and Lumonus AI, that assist healthcare providers (HCPs) with prescriptions, dosing, and treatment for cancer patients. The platform enables HCPs to access and communicate treatment information with patients and other providers. Although cancer patients can review lab data and treatment planning through the software, the information is input by doctors and does not contain patient-specific information or data.
The Lumonus AI software includes a module called Sigma that suggests treatment protocols based on prior treatment plans for similar patients in its database. Sigma uses machine learning to analyze a patient's cancer type and overall risk. By recommending the most relevant treatment plan, Sigma saves time when HCPs decide on the appropriate treatment plan.
The Challenge: Securing CDSS Exemption & Redesigning for Compliance
Based on the capabilities of its software products, Lumonus was uncertain whether adding the Sigma module would reclassify them as medical devices under FDA requirements, which would demand significant additional resources to support. The company sought regulatory expertise to review the software and determine if it qualified for an exemption, as well as an expert in software function review and engineering to redesign the software to meet regulatory requirements.
Clarifying Exemption Eligibility & Redesign Requirements
Lumonus approached Rook Quality Systems (Rook) to review its software products comprehensively and determine whether it qualified for a clinical decision support software (CDSS) exemption (also known as a 513-G submission). To qualify for a CDSS exemption, the software must adhere to the following guidelines:
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Does not diagnose or treat patients
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Ensures user control over decisions
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Does not contain patient information and requires professional input
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Poses minimal risk to patient safety
Rook collaborated with Grasp Health to leverage its unique expertise in medical software development to review the compatibility of its software product modules and help redesign the software as needed to achieve compliance.
Comprehensive Review, Function Assessment, & Software Redesign
CDSS Exemption
Rook comprehensively reviewed both Lumonus software products. Because the software suggested possible treatment plans based on previous inputs and the HCPs made the treatment decisions, the software did not qualify as diagnosing or treating patients. Ultimately, Rook confirmed that they qualified for the CDSS exemption and wrote and submitted CDSS exemption applications to the FDA.
Software Function Review
Rook reviewed both software programs to determine whether they complied with regulatory requirements. Rook suggested modifications to the software, including explaining to the HCPs what factors influenced Sigma’s decision-making, including age, cancer type/location, and proximity to organs. Rook also suggested clarifying to HCPs why certain factors were given more weight in the decision-making process than others.
Software Development
Rook provided a demo of their proposed redesigned software elements to Lumonous and partitioned the product into several modules to ensure compability with the CDSS guidance. They participated in the redesign and ensured all required testing was completed before submission.
The Result: Successful CDSS Exemption & Timely Delivery
Rook successfully submitted the CDSS exemption applications for the software programs, both of which were approved. During the application development and submission process, Rook’s regulatory and quality management expertise—combined with Grasp Health’s engineering experience—ensured that the redesigned software module met regulatory standards while enhancing functionality and compliance.
Ultimately, Rook and Grasp Health delivered on these outcomes in an incredibly tight timeline. Only 15 months passed between Lumonus' first contact with Rook and the approval of both applications, highlighting the unparalleled capacity of both companies to meet their clients’ objectives and combine regulatory document assistance with software development and review.
