Lantheus subsidiary wins FDA clearance for AI software

By staff writers

July 30, 2021 -- Lantheus Holdings announced that its Exini Diagnostics subsidiary was granted U.S. Food and Drug Administration (FDA) 510(k) clearance for its artificial intelligence (AI)-based automated Prostate Cancer Molecular Imaging Standardized Evaluation (aPROMISE) software.

With this clearance, clinicians can now use aPROMISE with the firm's Pylarify (piflufolastat F-18) radiotracer to quantitatively assess prostate-specific membrane antigen (PSMA) PET/CT images, according to Lantheus. The software is based on a deep-learning algorithm that was trained and validated on over 3,000 PSMA images to date, the company said.

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