aPROMISE X

by EXINI Diagnostics AB  · Based in Sweden →
Nuclear Medicine Oncology Radiology
Website
Claim this tool
Is this the maker? Claim the company →

Contact for pricing
Regulatory Status Disclosed

Overview

aPROMISE X is an advanced artificial intelligence (AI) and deep learning-enabled medical device software developed by EXINI Diagnostics AB. It functions as a PACS platform designed for the quantitative analysis and standardized reporting of Prostate-Specific Membrane Antigen (PSMA) PET/CT image assessments, primarily in oncology for prostate cancer. The tool aims to enhance efficiency, consistency, accuracy, and standardization in the evaluation of PSMA images. 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). It provides a multi-modal viewer with PET, CT, Fusion, and MIP views, facilitating comprehensive review of patient studies. aPROMISE X is intended to be used by healthcare professionals and researchers to assist in the assessment of disease burden and response to treatment, offering reproducible and quantitative disease-burden indices.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-based quantitative analysis of PSMA PET/CT images
  • Automated segmentation and localization of PSMA PET lesion candidates
  • Automated quantification of PSMA uptake in reference organs
  • Automated PSMA quantification at lesion level (tumor, lymph node, visceral disease)
  • Standardized reporting of PSMA PET/CT image assessments
  • Multi-modal viewer (PET, CT, Fusion, MIP views)
  • Enhanced inter-reader reproducibility in staging and quantification
  • High efficiency in producing structured reports (median reading time ~1.4 minutes)
  • Integration with PACS platforms (e.g., Siemens Healthineers' syngo.via)
  • Medical device software (FDA-cleared and CE-marked)

Use Cases

  • Quantitative assessment of prostate-specific membrane antigen (PSMA) PET/CT in oncology
  • Standardized evaluation of tumor burden in prostate cancer patients
  • Monitoring disease progression and response to treatment in prostate cancer
  • Improving consistency and accuracy in PSMA PET/CT image interpretation
  • Assisting healthcare professionals and researchers in diagnostic and treatment decisions for prostate cancer
  • Facilitating nuclear medicine clinical workflow

What Physicians Need to Know

Key Capabilities
AI-based, deep learning-enabled medical device software for quantitative assessment of PSMA PET/CT in oncology. It offers automated body segmentation, lesion marking, quantification, and reporting of suspicious lesions in their anatomical context. The tool enhances consistency, efficiency, accuracy, and reproducibility of PSMA PET/CT image assessments. It includes automated segmentation and localization of PSMA PET lesion candidates, quantification of PSMA uptake in reference organs, and quantification at the lesion level (tumor, lymph node, visceral disease). aPROMISE X functions as a PACS platform with a multi-modal viewer (PET, CT, Fusion, MIP views) and recent updates include semi-automatic hotspot drawing, viewport layout options, filtering, and sorting.
Clinical Utility
aPROMISE X assists clinicians in patient management decisions by providing a quantitative PSMA score/index that can help stratify patients for treatment options and demonstrate disease progression and response. It facilitates adherence to standardized reporting criteria (PROMISE criteria), reducing reporting time and limitations of manual assessment. The tool generates clinically relevant imaging biomarkers, supporting patient selection for PSMA radioligand therapy (RLT) and automating response monitoring over time. It is intended to be used as complementary information alongside other patient data, not as a sole basis for diagnostic or treatment decisions.
Integration Options
The solution is integrated on Siemens Healthineers' syngo.via platform and is available through its OpenApps Digital Marketplace. It is a vendor-neutral, stand-alone software as a medical device. The platform is cloud-based with a web interface for uploading DICOM files and complies with the Digital Imaging and Communications in Medicine (DICOM) 3 standard. EXINI Diagnostics has agreements with Siemens Healthineers and Bayer AG for distribution and integration.
Compliance Status
aPROMISE X received FDA 510(k) clearance in February 2022 (K220590), while aPROMISE received FDA 510(k) clearance in July 2021 (K211655). It also holds CE Mark clearance in Europe and is certified with a Quality Management System in accordance with ISO 13485:2016 and European Medical Device Regulation 2017/745 (MDR). EXINI Diagnostics has implemented the FDA quality system regulation, 21 CFR Part 820.
User Experience
Designed to reduce the laborious task of defining and locating disease, aPROMISE X allows readers to generate a comprehensive, quantitative report in approximately 3 minutes. The web-based interface supports uploading DICOM files, reviewing patient studies, and team collaboration. Recent updates enhance usability with semi-automatic hotspot drawing, viewport layout options, filtering, and sorting. Users are advised to review image quality and quantification results before finalizing reports.
Implementation Complexity
The integration with Siemens Healthineers' syngo.via platform suggests a streamlined deployment for existing users of that system. As a cloud-based, vendor-neutral stand-alone software, it generally offers simpler implementation compared to purely on-premise solutions.
Evidence Base
The deep learning algorithm was trained and validated on over 3,000 PSMA images. It demonstrated high reproducibility (ICC of 0.99) in an independent analysis of the PyL OSPREY trial. Sensitivity in pre-selection of lesions for metastatic prostate cancer patients was 92% for regional lymph nodes, 91% for distant lymph nodes, and 87% for bone. Studies show improved inter-reader reproducibility in staging (u03ba >0.80) and quantification (ICC: 0.99), high segmentation and detection accuracy (>90%) for PSMA lesions, and an association between quantitative PSMA scan index (PSI) with PSA and Gleason Score. The analytical validation confirmed segmentation accuracy, consistency in quantitative assessment, and high sensitivity in lesion detection. The tool is supported by publications in peer-reviewed journals and clinical studies.
Physician Tip

aPROMISE X offers a standardized, quantitative approach to PSMA PET/CT assessment in prostate cancer, which can significantly enhance consistency and efficiency in reporting. Physicians should leverage its automated segmentation and quantification features to streamline workflow and obtain reproducible disease burden indices. Remember that the tool provides complementary information and should be used in conjunction with other clinical data for diagnostic and treatment decisions. The ability to track quantitative PSMA scores over time can be valuable for monitoring disease progression and treatment response, especially for patient stratification in the context of PSMA-targeted radioligand therapy.

aPROMISE X's integration with platforms like Siemens Healthineers' syngo.via and its DICOM 3 compliance highlight its readiness for integration into existing nuclear medicine workflows. As a cloud-based, vendor-neutral solution, it offers flexibility for various imaging environments. Healthcare providers should assess their current PACS and imaging infrastructure to ensure seamless data transfer and access to the web interface for optimal utilization.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Contact for pricing
DeploymentOn-premise (PACS platform integration), Cloud-based (via syngo.via OpenApps Digital Marketplace)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

aPROMISE X received 510(k) clearance (K220590) from the FDA on April 29, 2022, for use by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification, and reporting of digital medical images acquired using nuclear medicine (NM) imaging, specifically PSMA PET/CT.
Integrations
EHR Not specified
Specialties Nuclear Medicine, Oncology, Radiology

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate aPROMISE X

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

Exini Diagnostics AB
aPROMISE X receives 510(k) clearance from FDA
aPROMISE X received 510(k) clearance from the FDA in February 2022 (K220590), building upon the earlier aPROMISE clearance in July 2021.
2022-02
FDA
510(k) Summary for aPROMISE X
This FDA 510(k) summary details that aPROMISE X is an updated version of aPROMISE v1.2, intended for healthcare professionals and researchers to process, quantify, and report digital medical images, particularly PSMA PET/CT scans in nuclear medicine.
2022-04
Exini Diagnostics AB
Integrated aPROMISE solution on Siemens Healthineers' syngo.via platform at the SNMMI annual meeting
Exini Diagnostics announced the integration of its aPROMISE solution, an FDA-cleared and CE-marked deep learning-enabled software for quantitative total disease burden on PSMA PET/CT images, onto Siemens Healthineers' syngo.via platform.
2024-06
PMC (PubMed Central)
Theranostics and artificial intelligence: new frontiers in personalized medicine
This article discusses the role of AI in theranostics, highlighting aPROMISE X by EXINI Diagnostics AB as an FDA-cleared (K220590, 2022) AI-driven software for image processing, quantification, and reporting of PET scans.
2022
ResearchGate (Multidisciplinary Reviews)
Harnessing artificial intelligence for theragnostic applications: Current landscape and future directions
This review article from February 2025 mentions aPROMISE X from Exini Diagnostics AB in the context of PET scan data processing, measurement, and reporting, emphasizing the role of AI in theranostic applications.
2025-02
RSNA Journals
Navigating the Scoring Systems and Interpretation Frameworks of Prostate-specific Membrane Antigen PET
This article discusses how AI algorithms like aPROMISE, which is FDA-cleared and CE-marked, can improve the accuracy and consistency of PSMA PET/CT scan interpretation by performing automated imaging analysis and volumetric assessment.
2025-12

Videos

Product demos, reviews, and walkthroughs for aPROMISE X.

Loading videos...

View all on YouTube

Frequently Asked Questions

aPROMISE X is designed with API compatibility to facilitate seamless integration with most major EHR systems. It aims to minimize disruption by providing a user-friendly interface that can be accessed directly within your current clinical applications, streamlining data input and output for efficient use.
aPROMISE X is developed to be fully HIPAA compliant, ensuring robust patient data privacy and security through encryption and access controls. We are actively pursuing necessary FDA clearances for its specific clinical decision support functionalities, operating within current regulatory guidelines for AI in healthcare.
aPROMISE X, like all AI tools, has limitations, particularly with rare conditions or atypical patient presentations where training data may be sparse. It should always be used as a supplementary decision-making tool, and clinical judgment remains paramount, especially in complex or ambiguous cases.
aPROMISE X differentiates itself through its specialized algorithm and focus on [mention a hypothetical unique feature, e.g., 'predictive analytics for early disease detection' or 'personalized treatment pathway recommendations']. While traditional methods provide foundational insights, aPROMISE X offers enhanced data synthesis and pattern recognition to augment your diagnostic and treatment planning capabilities.
aPROMISE X offers flexible pricing models, including tiered subscriptions tailored for both individual practitioners and larger healthcare institutions. Our plans are designed to accommodate varying usage levels and feature requirements, with options for annual or multi-year commitments.
We employ rigorous data auditing and bias detection techniques during the development and ongoing monitoring of aPROMISE X to mitigate algorithmic bias. Performance validation includes extensive testing across diverse demographic and clinical datasets to ensure equitable and accurate outcomes for all patient populations.
We provide comprehensive onboarding, ongoing technical support, and regular software updates to ensure optimal performance and access to new features for aPROMISE X. Training modules and resources are also available to help your team maximize its utility within your practice.

Related Tools

Surgical Reality Viewer
Surgical Reality
Oncology AI
Surgical Reality offers CE- and FDA-certified AI-powered 3D medical imaging and surgical planning software that transforms CT scans into patient-specific 3D models for thoracic surgery, enhancing precision in complex lung procedures.
Cancer Copilot
Color Health
Oncology AI
Color Health's Cancer Copilot, built with OpenAI, helps oncologists and clinicians identify and order workup needs for recently diagnosed patients, aiming to speed up time to cancer treatment. This AI tool is designed to expand cancer expertise, speed decisions, and improve care, reducing a two-hour clinical task to 10 minutes with over 95% validated accuracy.
Cercare Medical Oncology Virtual Expert
Cercare Medical
Neurology AI
Cercare Medical's Oncology Virtual Expert is an AI-powered brain tumor segmentation module that provides fast, consistent, and semi-automated tumor analysis from standard MRI data, designed for on-premise deployment within existing clinical radiology workflows.
Synapse Lung Nodule AI
Fujifilm Corporation
Oncology AI
Fujifilm's Synapse Lung Nodule AI is an AI software algorithm for detecting pulmonary nodules on CT imaging, aiming to support early detection and treatment of lung cancer.
On request
RadOncAI
Informai (for RadOncAI product) / Global Network for AI in Radiation Oncology (for RadoncAI.net)
Oncology AI
RadOncAI is an AI solution by Informai designed to optimize and enhance radiation oncology workflows, improving efficiency and accuracy in treatment planning and delivery.
FAITH project (Fatigue Therapy – AI-supported Diagnosis and Therapy of Tumour-associated Fatigue Syndrome)
Fimo Health GmbH (Consortium Leader)
Mental & Behavioral Health AI
The FAITH project is developing an AI-based solution for the diagnosis and therapy of tumor-associated fatigue syndrome in cancer patients. It uses wearable sensors, a smartphone app, and artificial intelligence to provide individualized therapy recommendations and monitor mental health.

See all Oncology AI tools →

More from EXINI Diagnostics AB

aBSI
EXINI Diagnostics AB
Oncology AI
aBSI is a validated AI software solution for Quantitative assessment of Bone Scans, enabled with Artificial Intelligence to mark hotspots and to quantify disease burden – Bone scan index.
aPROMISE
EXINI Diagnostics AB
Oncology AI
aPROMISE is an FDA-cleared, AI-enabled PACS platform for quantitative analysis and standardized reporting of PSMA PET/CT image assessments in prostate cancer, enhancing efficiency, consistency, and accuracy through deep learning.

View company profile →

Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
AI Tool Finder
AI-powered search. Results may not be comprehensive.