The software consists of a solution for automated body segmentation and marking, quantifying and reporting suspicious lesions
FDA Laboratory Building 62 houses the Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Lantheus Holdings announced that its subsidiary EXINI Diagnostics has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its digital application aPROMISE.
aPROMISE (automated PROstate Cancer Molecular Imaging Standardized Evaluation) is an artificial intelligence (AI)-based, medical device software.
The software enables healthcare professionals and researchers to perform quantitative assessment of PSMA PET/CT images in prostate cancer.
aPROMISE uses a deep learning algorithm trained and validated across over 3,000 PSMA images.
In May this year, EXINI Diagnostics secured CE mark approval for the software.
Lantheus chief business officer Etienne Montagut said: “Lantheus is pleased with the FDA clearance of aPROMISE, our AI-enabled digital application that expands our PSMA platform.
“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.”
aPROMISE is intended for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images.
The software allows rapid quantification of prostate cancer lesions in anatomical context. It consists of a solution for automated body segmentation and marking, quantifying and reporting suspicious lesions.
To increase the efficiency and reproducibility of PSMA PET/CT assessments, clinicians are also provided with an option to utilise aPROMISE with PYLARIFY (piflufolastat F 18).
PYLARIFY, which was recently approved by the FDA, is a prostate-specific membrane antigen (PSMA)-targeted PET imaging agent for prostate cancer.
It enables visualisation of lymph nodes, bone and soft tissue metastases to identify the presence or absence of recurrent and/or metastatic prostate cancer.
The approval of PYLARIFY is based on data from two company-sponsored pivotal studies that include OSPREY and CONDOR. The studies were designed to prove the safety and diagnostic performance of PYLARIFY across the prostate cancer disease continuum.
Lantheus Holdings is the parent company of Lantheus Medical Imaging, Progenics Pharmaceuticals, and EXINI Diagnostics.