GE HealthCare’s MIM Software Gets FDA OK for Monte Carlo Dosimetry

GE HealthCare’s MIM Software has received U.S. Food and Drug Administration (FDA) 510(k) clearance to perform absorbed dose calculation of radionuclides using a Monte Carlo method.
 
With this clearance, Monte Carlo dosimetry via the Dose Planning Method (DPM) will be available with MIM SurePlan MRT, MIM Software’s solution for automating and standardizing dosimetry in Theranostics. The practice of Theranostics relies on advanced molecular imaging, targeted therapies, and accurate dosimetry working together to provide a personalized, precise approach to diagnosis and treatment.
 
The Monte Carlo method is considered a “gold standard” for RPT dosimetry and has been shown to achieve high calculation accuracy in tissues of heterogeneous densities, including lungs. Traditionally, the Monte Carlo technique has been considered too slow for clinical use, taking up to several hours or more to complete calculations.
 
“It is exciting that the Dose Planning Method code developed and validated at our institution will be available to the Theranostics community at large with the recent FDA clearance,” said Yuni Dewaraja, PhD, Professor, Radiology, University of Michigan. “This opens up the possibility for harmonized and accurate patient-specific dosimetry across centers, which can lead to robust dose-effect relationships, dosimetry-guided radiopharmaceutical therapy, and ultimately a greater benefit for patients receiving these promising therapies.”
 
MIM SurePlan MRT turns an otherwise cumbersome process of performing dosimetry into a clinically realistic process via automation and standardization. In a few clicks, and with built-in guidance, users can review absorbed doses. Steps such as SPECT reconstruction, organ-at-risk segmentation, and time-activity curve fitting can be automated.
 
“Enabling wide access to precise, personalized treatment options for cancer is a key part of our mission,” said Andrew Nelson, CEO of MIM Software, GE HealthCare. “With the addition of Monte Carlo dosimetry for radiopharmaceutical therapy, we are excited to offer healthcare organizations fast, accurate absorbed dose calculation without needing to acquire additional computer hardware. We hope this will ultimately increase the number of patients who have access to personalized Theranostics.”