MIM Software, a GE HealthCare company, has received 510(k) clearance from the US Food and Drug Administration (FDA) for the use of Monte Carlo dosimetry in Theranostics.
Theranostics treats each patient using advanced molecular imaging, targeted therapies, and precise dosimetry for accurate diagnosis and treatment.
The approval secured by MIM Software allows for absorbed dose calculations of radionuclides using the Monte Carlo method.
Monte Carlo dosimetry through the Dose Planning Method (DPM) will now be integrated into the MIM SurePlan MRT solution. MIM SurePlan MRT is designed for automating and standardising dosimetry in Theranostics.
GE HealthCare gained rights to the MIM SurePlan MRT technology through the acquisition of MIM Software in April 2024.
According to GE HealthCare, the Monte Carlo method is now regarded as the gold standard for RPT dosimetry. It is said to offer high calculation accuracy in tissues with heterogeneous densities.
DPM is a Monte Carlo technique developed by the University of Michigan. This technique enables precise simulation of photons and electrons.
MIM SurePlan MRT with DPM is said to deliver fast and accurate Monte Carlo dose calculations in seconds. This is achieved using the existing central processing unit in healthcare organisations, and without using a graphics processing unit.
The product also simplifies the dosimetry process through automation and standardisation. Users can review absorbed doses with built-in guidance in few clicks, GE HealthCare said.
In addition, key steps like SPECT reconstruction, organ-at-risk segmentation, and time-activity curve fitting can be automated, making the process clinically realistic.
GE HealthCare CEO Andrew Nelson said: “Enabling wide access to precise, personalised treatment options for cancer is a key part of our mission,”
“With the addition of Monte Carlo dosimetry for radiopharmaceutical therapy, we are excited to offer healthcare organisations fast, accurate absorbed dose calculation without needing to acquire additional computer hardware.”
The addition of Monte Carlo dosimetry is expected to strengthen MIM SurePlan MRT’s status as a comprehensive, vendor-neutral dosimetry solution. It is used by many healthcare facilities, with installations in 23 countries across four continents.
Monte Carlo dosimetry for radiopharmaceutical therapies is the latest enhancement to GE HealthCare’s portfolio for Theranostics. This solution supports every step of the Theranostics treatment pathway, including isotopes, imaging, informatics, molecular imaging agents, and digital tools.
Last month, GE HealthCare secured FDA approval for Flyrcado (flurpiridaz F 18) injection. Flyrcado is a positron emission tomography (PET) radiotracer designed for enhanced diagnosis of coronary artery disease (CAD).
