Lantheus subsidiary wins FDA clearance for AI software

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.