San Francisco, CA (UroToday.com) -- Lantheus Holdings, Inc., an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics, and artificial intelligence solutions to find, fight and follow serious medical conditions, announced that PYLARIFY AI™, its recently FDA-cleared medical device software, is now commercially available in the United States.
PYLARIFY AI employs a deep learning algorithm that has been trained and validated across more than 3,000 images to allow healthcare professionals and researchers to perform standardized quantitative assessment of PSMA PET/CT images in prostate cancer. Through rigorous analytical and clinical studies, PYLARIFY AI has demonstrated improved consistency, accuracy, and efficiency in quantitative assessment of PSMA PET/CT.1,2
“PYLARIFY AI is the first and only FDA-cleared medical device software that offers a standardized platform for quantifying PSMA PET/CT images,” said Mary Anne Heino, President and Chief Executive Officer of Lantheus. “We believe that PYLARIFY AI could enhance the efficient integration of PSMA PET/CT into clinical practice and will be a vital tool to support the adoption of PYLARIFY.”PYLARIFY AI can be deployed either as a secure web cloud application or within the secure firewall of the institution on a local server. Once deployed, the adaptive application can be integrated into an institution’s existing clinical workflow, delivering a unique combination of clinical utility and technical flexibility.
“PSMA PET imaging is revolutionizing the visualization of prostate cancer metastases and thus the staging of the disease. Additionally, used as a biomarker it can provide whole-body assessment of target expression before initiation of PSMA-targeted therapies,” said Jeremie Calais, MD, MSc, Assistant Professor, Department of Molecular and Medical Pharmacology, Director, UCLA Theranostics Program, Ahmanson Translational Theranostics Division, University of California, Los Angeles. “An application that provides a quantifiable and reproducible assessment of PSMA uptake and distribution in the body is critical to enabling widespread adoption of PSMA PET for staging, therapy response assessment, and selection to or for PSMA-targeted therapy in patients with prostate cancer. The availability of PYLARIFY AI takes us one more step toward individualized, precision oncology.”
Source: Anon, Lantheus announces PYLARIFY AI™ is now available. Lantheus Holdings, Inc.