aPROMISE

JSON twin: https://www.healthaidb.com/software/apromise.json

Company Name

EXINI Diagnostics

Product URL

https://exini.com/software-solutions/apromise/

Company URL

https://exini.com

Categories

• clinical Care
• diagnostic Support
• oncology Care
• imaging Software
• ai Clinical Documentation Integrity
• clinical Decision Support
• Clinical
• Diagnostic
• Oncology
• Imaging
• Artificial Intelligence

Summary

aPROMISE is an AI-driven software that automates the analysis and reporting of PSMA PET/CT images in prostate cancer, enhancing efficiency and consistency in diagnostics.

Description

aPROMISE is an AI-based medical device software developed by EXINI Diagnostics AB, a subsidiary of Lantheus Holdings, Inc. It utilizes deep learning algorithms to perform quantitative assessments of PSMA PET/CT images in prostate cancer patients, automating tasks such as segmentation, localization, and quantification of lesions and reference organs. This leads to standardized reporting and improved reproducibility among clinicians. The software has received CE Mark clearance in Europe and 510(k) clearance from the U.S. FDA, indicating its safety and efficacy for clinical use. It is integrated into platforms like Siemens Healthineers' syngo.via and has been adopted by over 800 sites worldwide. The latest version, released in August 2024, includes features like updated triangulation, semi-automatic hotspot drawing, viewport layout options, and filtering and sorting capabilities. aPROMISE is available in multiple languages and is marketed in various countries, including the United States and European nations. It operates on a subscription-based pricing model, with specific details available upon request. The company, EXINI Diagnostics AB, was founded in 1999 and has offices in Sweden and the United States.

Api Available

unknown

Certifications

• FDA 510(k)
• CE/MDR
• ONC
• ISO

Company Founding

1999

Company Offices

• Sweden
• United States

Compliance

• HIPAA
• GDPR
• ISO 27001
• SOC 2
• FDA 510(k)
• CE/MDR
• ONC
• ISO

Customers

Data Residency

EU-only, US/EU regions, BYO cloud region

Data Standards

• DICOM
• HL7
• FHIR
• ICD-10
• SNOMED CT
• LOINC
• CPT
• ICD-11

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Automated segmentation and localization of PSMA PET lesions
• Quantitative analysis of PSMA uptake in reference organs
• Quantification of PSMA uptake at lesion level (tumor, lymph node, visceral disease)
• Multi-modal viewer supporting PET, CT, Fusion, and MIP views
• Automated CT image analysis for anatomical region segmentation (e.g., liver, aorta)
• Hotspot selection tool for reporting and quantitative analysis
• Team collaboration through shared patient lists and study assessments

Id

SW0461

Integration Partners

Integrations

• PACS systems
• EHR systems
• External imaging modalities
• Cloud storage services
• Mobile devices
• Data backup solutions
• Recovery solutions
• User training platforms
• Support services
• External reporting tools
• External analytics tools
• External visualization tools

Languages Supported

• English
• Swedish
• German
• French
• Spanish
• Italian
• Dutch
• Danish
• Norwegian
• Finnish
• Polish
• Portuguese
• Czech
• Greek
• Hungarian
• Romanian
• Bulgarian
• Slovak
• Slovenian
• Croatian

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• Advanced reporting tools
• Integration with external PACS systems
• Customizable user interface themes
• Advanced analytics and visualization tools
• Integration with electronic health records (EHR) systems
• Support for additional imaging modalities
• Mobile application for remote access
• Cloud storage integration
• Data backup and recovery solutions
• User training and support services

Os Platforms

• Web
• Windows
• macOS
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0461

Product Name

aPROMISE

Ratings

Regions Available

• United States
• European Union
• Sweden
• Germany
• France
• United Kingdom
• Italy
• Spain
• Netherlands
• Belgium
• Denmark
• Norway
• Finland
• Poland
• Austria
• Switzerland
• Portugal
• Ireland
• Greece
• Czech Republic

Related Urls

• https://investor.lantheus.com/news-releases/news-release-details/exini-diagnostics-ab-lantheus-company-receives-ce-mark-clearance
• https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-announces-first-and-only-fda-cleared-ai-enabled-psma
• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Encryption
• RBAC
• SSO/SAML
• Audit logs
• 2FA
• DLP

Specialties

• Prostate Cancer
• Nuclear Medicine
• Radiology

Support Channels

System Requirements

Windows 10 or later, macOS 10.15 or later, Linux distributions (Ubuntu 20.04 or later), 8 GB RAM, 2 GB GPU memory, 500 MB free disk space

Target Users

• clinicians
• radiologists
• oncologists
• medical imaging professionals

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "aPROMISE",
  "company_name": "EXINI Diagnostics",
  "product_url": "https://exini.com/software-solutions/apromise/",
  "company_url": "https://exini.com",
  "related_urls": [
    "https://investor.lantheus.com/news-releases/news-release-details/exini-diagnostics-ab-lantheus-company-receives-ce-mark-clearance",
    "https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-announces-first-and-only-fda-cleared-ai-enabled-psma",
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0461",
  "summary": "aPROMISE is an AI-driven software that automates the analysis and reporting of PSMA PET/CT images in prostate cancer, enhancing efficiency and consistency in diagnostics.",
  "description": "aPROMISE is an AI-based medical device software developed by EXINI Diagnostics AB, a subsidiary of Lantheus Holdings, Inc. It utilizes deep learning algorithms to perform quantitative assessments of PSMA PET/CT images in prostate cancer patients, automating tasks such as segmentation, localization, and quantification of lesions and reference organs. This leads to standardized reporting and improved reproducibility among clinicians. The software has received CE Mark clearance in Europe and 510(k) clearance from the U.S. FDA, indicating its safety and efficacy for clinical use. It is integrated into platforms like Siemens Healthineers' syngo.via and has been adopted by over 800 sites worldwide. The latest version, released in August 2024, includes features like updated triangulation, semi-automatic hotspot drawing, viewport layout options, and filtering and sorting capabilities. aPROMISE is available in multiple languages and is marketed in various countries, including the United States and European nations. It operates on a subscription-based pricing model, with specific details available upon request. The company, EXINI Diagnostics AB, was founded in 1999 and has offices in Sweden and the United States.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "oncology Care",
    "imaging Software",
    "ai Clinical Documentation Integrity",
    "clinical Decision Support",
    "Clinical",
    "Diagnostic",
    "Oncology",
    "Imaging",
    "Artificial Intelligence"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "clinicians",
    "radiologists",
    "oncologists",
    "medical imaging professionals"
  ],
  "specialties": [
    "Prostate Cancer",
    "Nuclear Medicine",
    "Radiology"
  ],
  "regions_available": [
    "United States",
    "European Union",
    "Sweden",
    "Germany",
    "France",
    "United Kingdom",
    "Italy",
    "Spain",
    "Netherlands",
    "Belgium",
    "Denmark",
    "Norway",
    "Finland",
    "Poland",
    "Austria",
    "Switzerland",
    "Portugal",
    "Ireland",
    "Greece",
    "Czech Republic"
  ],
  "languages_supported": [
    "English",
    "Swedish",
    "German",
    "French",
    "Spanish",
    "Italian",
    "Dutch",
    "Danish",
    "Norwegian",
    "Finnish",
    "Polish",
    "Portuguese",
    "Czech",
    "Greek",
    "Hungarian",
    "Romanian",
    "Bulgarian",
    "Slovak",
    "Slovenian",
    "Croatian"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "Sweden",
    "United States"
  ],
  "company_founding": "1999",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Automated segmentation and localization of PSMA PET lesions",
    "Quantitative analysis of PSMA uptake in reference organs",
    "Quantification of PSMA uptake at lesion level (tumor, lymph node, visceral disease)",
    "Multi-modal viewer supporting PET, CT, Fusion, and MIP views",
    "Automated CT image analysis for anatomical region segmentation (e.g., liver, aorta)",
    "Hotspot selection tool for reporting and quantitative analysis",
    "Team collaboration through shared patient lists and study assessments"
  ],
  "optional_modules": [
    "Advanced reporting tools",
    "Integration with external PACS systems",
    "Customizable user interface themes",
    "Advanced analytics and visualization tools",
    "Integration with electronic health records (EHR) systems",
    "Support for additional imaging modalities",
    "Mobile application for remote access",
    "Cloud storage integration",
    "Data backup and recovery solutions",
    "User training and support services"
  ],
  "integrations": [
    "PACS systems",
    "EHR systems",
    "External imaging modalities",
    "Cloud storage services",
    "Mobile devices",
    "Data backup solutions",
    "Recovery solutions",
    "User training platforms",
    "Support services",
    "External reporting tools",
    "External analytics tools",
    "External visualization tools"
  ],
  "data_standards": [
    "DICOM",
    "HL7",
    "FHIR",
    "ICD-10",
    "SNOMED CT",
    "LOINC",
    "CPT",
    "ICD-11"
  ],
  "api_available": "unknown",
  "system_requirements": "Windows 10 or later, macOS 10.15 or later, Linux distributions (Ubuntu 20.04 or later), 8 GB RAM, 2 GB GPU memory, 500 MB free disk space",
  "compliance": [
    "HIPAA",
    "GDPR",
    "ISO 27001",
    "SOC 2",
    "FDA 510(k)",
    "CE/MDR",
    "ONC",
    "ISO"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE/MDR",
    "ONC",
    "ISO"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit logs",
    "2FA",
    "DLP"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization"
  ],
  "data_residency": "EU-only, US/EU regions, BYO cloud region",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0461",
  "slug": "apromise",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/apromise.json"
  }
}