AI-enabled Software To Detect Prostate Cancer Bone Metastases Clears FDA

AI-enabled Software To Detect Prostate Cancer Bone Metastases Clears FDA
An artificial intelligence (AI) program that aims to make it easier to identify bone metastases in men with prostate cancer has been granted 501(k) clearance by the U.S. Food and Drug Administration (FDA), its developer announced. The program uses a neural network — a type of AI — to identify hotspots on bone scans indicative of bone metastasis, which is when cancer cells spread from the prostate and start growing in bone tissue. It also calculates the automated bone scan index or aBSI, an imaging marker that can help detect changes in bone health in men with prostate cancer. Traditionally, bone scans are assessed manually by a clinician, a process that can be time-consuming and that may be subject to human error. The new program, owned by Lantheus Holdings and also called aBSI, offers a fast and reliable alternative to manual interpretation for detecting hotspots that indicate bone metastases. Multiple studies have demonstrated the clinical utility of the aBSI index as a prognostic and a response imaging biomarker in patients with metastatic prostate cancer. "aBSI has demonstrated clinical value in quantifying and managing disease progressio
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