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Lantheus Announces the First and Only FDA Cleared AI-Enabled PSMA Digital Application, aPROMISE™, Strengthening Lantheus’ Leadership in Prostate Cancer
aPROMISE was developed to quantify and standardize assessment of PSMA PET/CT images and will support PYLARIFY® (piflufolastat F 18) adoption in the U.S.
About this update from Lantheus Holdings, Inc.
[{"type":"text","content":"\naPROMISE was developed to quantify and standardize assessment of PSMA PET/CT images and will support PYLARIFY® (piflufolastat F 18) adoption in the U.S.\n\n NORTH BILLERICA, Mass.--(BUSINESS WIRE)--\nLantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus) announced today that its subsidiary, EXINI Diagnostics AB, was granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its digital application, aPROMISE™ (automated PROstate Cancer Molecular Imaging Standardized Evaluation). Clinicians will have the option to utilize aPROMISE with PYLARIFY® (piflufolastat F 18) to increase the efficiency and reproducibility of their PSMA PET/CT assessments. PYLARIFY was recently approved by the FDA and is the first and only commercially available PSMA-targeted PET imaging agent for prostate cancer.\n\naPROMISE is an artificial intelligence-based, medical device software that uses a deep learning algorithm trained and validated across over 3,000 PSMA images to date, to allow healthcare professionals and researchers to perform quantitative assessment of PSMA PET/CT images in prostate cancer. The PROMISE criteria were developed by leading experts in prostate cancer imaging to standardize quantitative evaluation of prostate cancer lesions by location using prostate-specific membrane antigen (PSMA) PET/CT.1 aPROMISE facilitates rapid and robust quantification of prostate cancer lesions in anatomical context, enabling clinicians to make routine use in the clinic of a comprehensive, automated approach to patient evaluation. aPROMISE includes a solution for automated body segmentation and marking, quantifying and reporting suspicious lesions in their anatomical context. aPROMISE provides enhanced consistency in quantitative analysis and standardized reports and has demonstrated increased efficiency and reproducibility of clinicians’ PSMA PET/CT image assessments.2,3\n\n“Lantheus is pleased with the FDA clearance of aPROMISE, our AI-enabled digital application that expands our PSMA platform,” said Etienne Montagut, Chief Business Officer for Lantheus. “We are excited to provide such an innovative tool for PSMA quantification and reporting that can empower clinicians to make more informed treatment decisions for their prostate cancer patients.”\n\naPROMISE Indications for Use\n\naPROMISE is intended to be used by healthcare professionals ...