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.”
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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.”
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PYLARIFY AI
PYLARIFY AI Indications for Use
PYLARIFY AI is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging using PSMA PET/CT. The device provides general picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis.
PYLAIRFY AI Warnings and Precautions
The user must ensure that the patient’s name, ID, and study date displayed in the patient section correspond to the patient case. The user must ensure the review of the image quality and quantification analysis results before signing the report. User must review the images and quantification results in the report to ensure that the information saved and exported is correct. The quantification analysis results provided by PYLARIFY AI are intended to be used as complementary information together with other patient information. The user shall not rely solely on the information provided by PYLARIFY AI for diagnostic or treatment decisions. Quantitative indexes (ITLV, and LI) are only appropriate for PSMA PET/CT images. User should not select hotspots for studies with images that do not fulfill the Quality Control requirements. In such cases, user can create and sign a report indicating that the review cannot be done due to image quality deficiencies.
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