aPROMISE
Overview
aPROMISE is an AI-based, deep learning-enabled medical device software developed by EXINI Diagnostics AB, a subsidiary of Lantheus Holdings, Inc. It functions as a PACS platform offering quantitative analysis and standardized reporting of PSMA PET/CT image assessments, primarily for prostate cancer. The tool leverages deep learning technology to enhance efficiency, consistency, accuracy, and standardization in PSMA image evaluation. It aims to reduce the laborious task of defining and locating disease, improve reproducibility among readers, and maintain high diagnostic accuracy.
Key functionalities include automated segmentation and localization of PSMA PET lesion candidates, automated segmentation and quantification of PSMA uptake in reference organs, and automated PSMA quantification at the lesion level (tumor, lymph node, and visceral disease). aPROMISE has demonstrated reproducible and quantitative disease-burden indices, improved inter-reader reproducibility in staging and quantification of prostate cancer patients, and high segmentation and detection accuracy for PSMA lesions. It significantly increases efficiency, allowing for comprehensive, quantitative reports in an average of approximately 3 minutes. The aPROMISE viewer is a multi-modal viewer with PET, CT, Fusion, and MIP views.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Automated segmentation and localization of PSMA PET lesion candidates
- Automated segmentation and quantification of PSMA uptake in reference organs
- Automated PSMA quantification at lesion level (tumor, lymph node, visceral disease)
- Reproducible and quantitative disease-burden indices
- Improved inter-reader reproducibility in staging and quantification
- High segmentation and detection accuracy (>90%) for PSMA lesions
- Significant efficiency in creating quantitative structure reporting (~3 min per report)
- Multi-modal viewer with PET, CT, Fusion, and MIP views
- Deep learning-enabled application
- Web interface for study review and sharing (aPROMISE X, an updated version)
Use Cases
- Quantitative assessment of PSMA PET/CT images in prostate cancer
- Standardized evaluation of tumor burden in prostate cancer patients
- Stratifying patients for available treatment options
- Accurately demonstrating disease progression and response
- Enhancing efficiency and reproducibility of PSMA PET/CT assessments
- Facilitating adherence to standardized reporting in clinical practice
What Physicians Need to Know
aPROMISE can significantly enhance the efficiency and consistency of PSMA PET/CT interpretation for prostate cancer, reducing manual assessment time to minutes. Leverage its automated quantitative disease burden indices (e.g., PSI) for more objective patient stratification, treatment selection (including RLT), and monitoring of response over time. While the AI provides robust lesion detection and quantification, always perform a thorough review of the images and analysis results to ensure accuracy and integrate with other clinical information for comprehensive decision-making. The multi-modal viewer facilitates this verification process.
aPROMISE is designed for seamless integration into existing nuclear medicine workflows, operating as a PACS platform and being DICOM compatible. Its availability on major vendor-neutral platforms like Siemens Healthineers' syngo.via via OpenApps Digital Marketplace simplifies deployment and access across various PET sites. Compatibility with PYLARIFYu00ae further streamlines PSMA PET/CT assessments.
Details
| Category | Oncology AI, Radiology & Imaging AI |
| Pricing | Unknown |
| Deployment | Cloud-based / Web-based (PACS platform with web interface) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated aPROMISE (automated PROstate Cancer Molecular Imaging Standardized Evaluation) received 510(k) clearance (K211655) from the U.S. Food and Drug Administration (FDA) on July 27, 2021. It is intended for use by healthcare professionals and researchers for the acceptance, transfer, storage, image display, manipulation, quantification, and reporting of digital medical images acquired using nuclear medicine (NM) imaging with PSMA PET/CT. |
| Integrations | |
| EHR | Not specified |
| Specialties | Nuclear Medicine, Oncology, Radiology |
What the Web Says
aPROMISE is an AI-based, deep learning-enabled medical device software developed by EXINI Diagnostics (a subsidiary of Lantheus Holdings Inc.) for quantitative assessment and standardized reporting of prostate-specific membrane antigen (PSMA) PET/CT in oncology. It aims to improve efficiency, accuracy, and reproducibility of PSMA PET/CT image assessments, assisting healthcare professionals and researchers in managing prostate cancer patients. The software has received CE Mark clearance in Europe and FDA clearance in the U.S..
Overall: PositiveStrengths
- Enhances consistency and reproducibility in quantitative analysis and reporting of PSMA PET/CT images.
- Increases efficiency by reducing the laborious task of defining and locating disease, with reports taking an average of ~3 minutes.
- Demonstrates high diagnostic accuracy for PSMA lesions, with sensitivity over 90% for regional and distant lymph nodes and 86.7-87% for bone.
- Provides automated body segmentation, marking, quantifying, and reporting of suspicious lesions in their anatomical context.
- Offers a standardized approach to PSMA imaging assessment, potentially aiding in patient stratification for treatment and monitoring disease progression.
- Improved inter-reader reproducibility in staging and quantification of prostate cancer patients.
Limitations
- Quantification analysis results are intended as complementary information and should not be solely relied upon for diagnostic or treatment decisions.
- Quantitative measurements are only appropriate for PSMA PET/CT images.
- Users should not select hotspots for studies with images that do not fulfill Quality Control requirements.
- Physicians still need to review images and make selections for lesions, as the technology assists rather than fully automates this step.
- Limited independent reviews from platforms like G2, Capterra, or Reddit were found, making it difficult to gauge broader user sentiment outside of scientific publications and company announcements.
Based on reviews from: EXINI Diagnostics Receives CE Mark Clearance for aPROMISE, aPROMISE - Exini Diagnostics AB, EXINI Diagnostics AB, a Lantheus Co., Receives CE Mark Clearance - AI-Tech Park, Integrated aPROMISE solution on Siemens Healthineers' syngo.via platform at the SNMMI annual meeting - Exini Diagnostics AB, News - Exini Diagnostics AB, aPROMISE: A Novel Automated-PROMISE platform to Standardize Evaluation of Tumor Burden in 18F-DCFPyL (PSMA) images of Veterans w - Journal of Nuclear Medicine, aPROMISE: A Novel Automated PROMISE Platform to Standardize Evaluation of Tumor Burden in 18F-DCFPyL Images of Veterans with Prostate Cancer - PubMed, Analytical performance of aPROMISE: automated anatomic contextualization, detection, and quantification of [18F]DCFPyL (PSMA) imaging for standardized reporting - PMC
Last updated: 2026-07-18
