FDA Clears MRI-Based AI Software for Assessment of Brain Metastases

The Food and Drug Administration (FDA) has granted 510(k) clearance for the artificial intelligence (AI)-powered software Brain Mets, which reportedly offers enhanced detection and measurement of brain metastases that can affect up to 40 percent of adult patients with cancer.

Through assessment of routine brain magnetic resonance imaging (MRI) scans, the Brain Mets software accelerates metastasis identification, measurement and contouring, according to Neosoma, the developer of the Brain Mets software.

“The FDA clearance of this software to detect and segment brain metastasis marks meaningful progress towards more efficient and objective imaging in neuro-oncology,” noted Rupesh Kotecha, M.D., the chief of radiosurgery and director of CNS metastasis in the Department of Radiation Oncology at the Miami Cancer Institute. “I look forward to seeing these tools being integrated across radiology, radiation oncology, and neuro-oncology workflows to support clinical decision-making and research."

Jona Hattangadi-Gluth, M.D., said the Brain Mets software could have a significant impact on longitudinal tracking of treatment response for patients with brain metastases.

"Brain metastases are common and complex, especially with the myriad of targeted systemic treatments and radiotherapy options. This technology will directly impact how we detect and surveil brain metastases after therapy, and allow us to quantify and measure response to novel therapeutics,” noted Dr. Hattangadi-Gluth, a professor at the University of California (UC)-San Diego School of Medicine and chief of the CNS tumor service in radiation oncology at Moores Cancer Center in San Diego.