GE HealthCare’s MIM Software today announced it received FDA 510(k) clearance for Monte Carlo dosimetry.
The latest clearance allows MIM Software to calculate radionuclide absorbed doses using a Monte Carlo method. Dosimetry will be available through the Dose Planning Method (DPM) and MIM SurePlan MRT, MIM Software’s solution for automating and standardizing dosimetry in theranostics.
Dosimetry in radiotherapy helps estimate the amount of dose that will be absorbed by normal tissues and tumors to anticipate the biological effects of radiation. Radiopharmaceutical therapy and theranostics are increasingly used to treat cancer, so the need to use dosimetry to personalize care is also increasing.
According to GE HealthCare, the Monte Carlo method is the gold standard for radiopharmaceutical therapy dosimetry. The company said it has been shown to achieve high calculation accuracy in tissues of heterogeneous densities.
“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, a professor of radiology at the 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.”
More about MIM SurePlan MRT
GE HealthCare acquired the MIM SurePlan MRT technology as part of its MIM Software acquisition earlier this year. The system has built-in guidance that allows users to review absorbed doses. It also has the ability to automate 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.”
GE HealthCare’s addition of Monte Carlo dosimetry for radiopharmaceutical therapies is the company’s latest addition to its growing theranostics portfolio. It aims to provide solutions for every step of the theranostics treatment pathway, including the isotopes, imaging, informatics, molecular imaging agents and digital tools necessary for the practice and advance of precision care.