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.
