GE HealthCare’s MIM Software Receives FDA Clearance for Monte Carlo Dosimetry in Theranostics

MIM Software, a subsidiary of GE HealthCare, has announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to calculate absorbed radionuclide doses using the Monte Carlo method. This clearance allows for the integration of Monte Carlo dosimetry via the Dose Planning Method (DPM) into MIM SurePlan MRT, the company’s comprehensive platform for automating and standardizing dosimetry in Theranostics.

Theranostics represents a highly personalized form of medicine, aimed at treating each patient based on their individual needs. It recognizes that a one-size-fits-all treatment and dosing approach does not work for everyone, with the ultimate goal of improving medical outcomes. This personalized approach relies on advanced molecular imaging, targeted therapies, and accurate dosimetry working together to diagnose and treat patients precisely and effectively.

Dosimetry in radiotherapy estimates the radiation dose absorbed by normal tissues and tumors, helping to predict biological effects. As Theranostics and radiopharmaceutical therapy (RPT) grow in popularity for treating cancer and other diseases, there is an increasing focus on using dosimetry to customize RPT treatments.

The Monte Carlo method, regarded as the “gold standard” for RPT dosimetry, offers high accuracy in calculating absorbed doses, even in tissues with varying densities, such as the lungs. The Dose Planning Method (DPM) is a Monte Carlo technique developed by the University of Michigan, enabling precise photon and electron simulations.

Yuni Dewaraja, PhD, Professor of Radiology at the University of Michigan, expressed enthusiasm for the FDA clearance: “This opens up the possibility for harmonized and accurate patient-specific dosimetry across centers, leading to better dose-effect relationships, dosimetry-guided RPT, and greater benefits for patients.”

While Monte Carlo techniques have historically been considered too slow for clinical use—often requiring hours for completion—MIM SurePlan MRT with the Dose Planning Method can deliver fast and accurate Monte Carlo calculations in seconds, using healthcare organizations’ existing central processing units without requiring specialized graphics processing units.

MIM SurePlan MRT simplifies the complex process of performing dosimetry through automation and standardization. It allows users to quickly review absorbed doses with a few clicks, automating steps such as SPECT reconstruction, organ-at-risk segmentation, and time-activity curve fitting.

Andrew Nelson, CEO of MIM Software, GE HealthCare, highlighted the significance of this development: “Our mission is to expand access to precise, personalized cancer treatment options. With Monte Carlo dosimetry for RPT, healthcare organizations can now perform fast, accurate absorbed dose calculations without additional hardware, increasing the number of patients who can benefit from personalized Theranostics.”

With the inclusion of Monte Carlo dosimetry, MIM SurePlan MRT strengthens its position as a leading, vendor-neutral dosimetry solution, trusted by numerous healthcare facilities designated as RPT Comprehensive Centers of Excellence by the Society of Nuclear Medicine & Molecular Imaging (SNMMI). The system is installed in 23 countries across four continents, making it a trusted solution worldwide.

Monte Carlo dosimetry for RPT is the latest addition to GE HealthCare’s Theranostics portfolio, which offers comprehensive solutions across the entire treatment pathway, including isotopes, imaging, informatics, molecular imaging agents, and digital tools for advancing precision care.

For more information about MIM SurePlan MRT, visit MIMSoftware.com. To learn more about GE HealthCare’s Theranostics offerings, visit GEHealthCare.com.

Source Link:

Newsletter Updates

Enter your email address below and subscribe to our newsletter