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.
![A 53-year-old patient (patient number four) with a recurrent pituitary adenoma with extension of a cystic component of disease to the medial temporal lobe apparent on MRI (contoured in blue), and extension of disease to the left sphenoid bone and orbital apex apparent on [68Ga]Ga-DOTA-TATE (contoured in yellow).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/04/pituitary-tumor.QGsEnyB4bU.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
