aBSI

by EXINI Diagnostics AB  · Based in Sweden → — AI Software for Quantitative Bone Scan Analysis
Nuclear Medicine Oncology

Regulatory Status Disclosed

Overview

aBSI (automated Bone Scan Index) by EXINI Diagnostics AB is an artificial intelligence-enabled software solution designed for the quantitative assessment of bone scans. Developed to support clinicians in managing metastatic bone disease, the tool automates the detection of hotspots in the skeleton and calculates the Bone Scan Index (BSI). This index represents the percentage of total skeletal mass affected by active tumor lesions.

The software is primarily utilized by nuclear medicine specialists, radiologists, and oncologists in clinical imaging centers, hospitals, and research settings. It is particularly focused on evaluating disease burden and tracking progression in patients with advanced, bone-metastatic prostate cancer.

To fit seamlessly into existing clinical workflows, aBSI is designed as a vendor-neutral, stand-alone platform. It integrates directly with major nuclear medicine workstations and imaging platforms, including Siemens Healthineers’ syngo.via and GE Healthcare’s Xeleris platform. Key capabilities of the tool include:

  • Automated Hotspot Detection: Rapidly identifies and marks skeletal areas showing abnormal radiopharmaceutical uptake.
  • Quantitative Disease Tracking: Standardizes the calculation of the Bone Scan Index to provide a reproducible metric of skeletal tumor burden over time.
  • Workflow Integration: Supports standard PACS tools for image display, manipulation, and reporting, offering a fast alternative to manual bone scan interpretation.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Quantitative assessment of bone scans
  • AI-enabled hotspot detection
  • Automated Bone Scan Index (BSI) calculation
  • Quantifies skeletal tumor burden
  • Prognostic determinant of overall survival in metastatic prostate cancer
  • Supports clinical trial design and eligibility
  • Integrated solutions with GE Healthcare and Siemens Healthineers
  • Web-based application
  • Accurate, quantitative, reproducible assessments
  • Real-time BSI value updates with editing

Use Cases

  • Assessing metastatic prostate cancer
  • Quantifying bone tumor burden
  • Monitoring treatment response in oncology
  • Supporting physician treatment decisions
  • Clinical trials for systemic therapies
  • Analyzing nuclear medicine bone scans in oncology

What Physicians Need to Know

Key Capabilities
aBSI is a validated AI software solution for quantitative assessment of bone scans, primarily for metastatic prostate cancer. It automatically marks hotspots and quantifies disease burden using the Bone Scan Index (BSI), offering accurate, quantitative, and reproducible results. The software updates the BSI value in real-time during editing of pre-selected hotspots.
Clinical Utility
aBSI serves as an independent prognostic determinant of overall survival in metastatic prostate cancer patients and supports the design and eligibility criteria for clinical trials involving systemic therapies. It aids in stratifying patients for treatment options and monitoring disease progression and response to therapy, such as Ra-223. It provides an objective measure of quantitative change in disease burden.
Integration Options
aBSI offers integrated solutions with major imaging vendors, including GE Healthcare (Xeleris platform) and Siemens Healthineers (clinical workstations, syngo.via platform). It also has an agreement with Bayer AG for integration into their Calanticu2122 Digital Solutions. The tool is available for local installation (EXINI bone) and as a secure, compliant web application (www.bonescanindex.com), adhering to the DICOM 3 standard for interoperability.
Compliance Status
aBSI is CE-marked in Europe according to MDR 2017/745 and received FDA 510(k) clearance in the United States (K191262) in August 2019. EXINI Diagnostics AB maintains a certified Quality Management System compliant with ISO 13485:2016 and implements FDA quality system regulation 21 CFR Part 820.
Pricing Model
Not publicly disclosed; typically license or subscription-based for medical software. Contact Exini Diagnostics AB for specific pricing details.
User Experience
The software is designed as a secure and compliant web application, accessible via a web browser. It features real-time updates of the BSI value when pre-selected hotspots are edited, aiming for an intuitive and efficient user workflow.
Support Quality
Exini Diagnostics AB emphasizes quality assurance as a core business principle and provides dedicated customer support. Information regarding service and support is available on their website.
Implementation Complexity
Implementation can range from direct integration with existing GE Healthcare and Siemens Healthineers workstations to local installation or web-based access, offering flexibility. Exini provides integration and deployment services to facilitate setup.
Evidence Base
aBSI is a validated AI solution supported by a prospectively defined multi-institutional phase 3 study involving 721 metastatic prostate cancer patients. Numerous publications document the technology, demonstrating high concordance with manual BSI and strong interobserver concordance (>0.95). It has shown safety and effectiveness in quantifying nuclear medicine bone scans in oncology, with high linearity in BSI interpretations (Pearson correlation of 0.995).
Physician Tip

aBSI offers an objective, quantitative, and reproducible assessment of bone tumor burden, particularly valuable for metastatic prostate cancer. It serves as an independent prognostic determinant of overall survival and can assist in stratifying patients for systemic therapies and clinical trials. While highly effective for monitoring disease progression and treatment response, always use aBSI results as a *guide* in conjunction with visual interpretation of bone scans and other comprehensive clinical data, rather than as the sole basis for diagnostic or treatment decisions. The real-time BSI updates during hotspot editing can enhance interactive assessment and workflow efficiency.

aBSI provides extensive integration options, including direct compatibility with leading imaging platforms such as GE Healthcare's Xeleris, Siemens Healthineers' clinical workstations (e.g., syngo.via), and Bayer AG's Calanticu2122 Digital Solutions. This broad compatibility, along with support for local installation (EXINI bone) and web-based access, offers significant flexibility for diverse clinical environments. Its adherence to the DICOM 3 standard further ensures seamless interoperability with existing Picture Archiving and Communication Systems (PACS).

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Unknown
DeploymentWeb application; also available for local installation (EXINI bone). Integrated with GE Healthcare and Siemens Healthineers platforms.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

aBSI received FDA 510(k) clearance (K191262) in August 2019 as a software as a medical device (SaMD) for the quantitative assessment of bone scans, particularly for metastatic prostate cancer.

Integrations
EHR Not specified
Specialties Nuclear Medicine, Oncology

Ratings & Reviews

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

Press & Coverage

Exini Diagnostics AB
EXINI Executes Agreement with Siemens Healthineers for the Distribution of its PSMA Artificial Intelligence Technology aPROMISE and quantitative assessment technology of bone scans aBSI
EXINI has partnered with Siemens Healthineers to integrate its AI-enabled software, aPROMISE and aBSI, into Siemens clinical workstations for broader distribution in nuclear medicine workflows.
2022-11
Exini Diagnostics AB
EXINI Executes Agreement with Bayer AG for the Distribution of its PSMA Artificial Intelligence Technology aPROMISE and quantitative assessment technology of bone scans aBSI
EXINI has entered an agreement with Bayer AG to integrate its AI-enabled software, aPROMISE and aBSI, into Bayer's medical imaging platform Calantic Digital Solutions.
2022-11
BioWorld
Lantheus receives clearance for AI-enabled bone scan run on GE Healthcare's Xeleris platform
Lantheus Holdings Inc. received FDA 510(k) clearance for its AI-enhanced aBSI product for prostate cancer on GE Healthcare's Xeleris platform, improving quantification and management of disease progression.
2020-11
Medical Device Network
FDA approves use of Lantheus' aBSI on GE Healthcare's Xeleris Platform
The FDA granted 510(k) approval to Lantheus for its AI-enabled aBSI product on GE Healthcare's Xeleris platform, following a global software licensing agreement.
2020-11
AACR Journals (Clinical Cancer Research)
Automated Imaging as an Adjunct to Serum and Clinical Biomarkers: A New Validated Prediction Tool for Metastatic Castration-Resistant Prostate Cancer
This study highlights aBSI as a commercially available software package with regulatory clearance in the US and Europe for clinical and clinical trial use in assessing metastatic prostate cancer.
2026-02
Annals of Nuclear Medicine
Comparison of automated bone scan indexes in patients with prostate cancer: aBSI and BONENAVI
A study comparing aBSI and BONENAVI software for automated bone scan index calculation in prostate cancer patients found strong correlation but noted aBSI tended to yield slightly higher BSIs, especially with increased disease burden.
2026-06
Journal of Nuclear Medicine (via PMC)
Prognostic Value of Automated Bone Scan Index (aBSI) in Patients with mCRPC Undergoing Three vs. Six Cycles of 223Ra Therapy
This research indicates that aBSI, determined automatically by EXINI Diagnostics AB, is a promising prognostic biomarker for assessing disease burden and monitoring therapeutic response in mCRPC patients undergoing 223Ra therapy.
2025-08
The ASCO Post
Automated Bone Scan Index and Overall Survival in Metastatic Castration-Resistant Prostate Cancer
A secondary analysis of the phase III 10TASQ10 trial demonstrated that the automated Bone Scan Index (aBSI) is predictive of overall survival in chemotherapy-naive metastatic castration-resistant prostate cancer.
2018-06

Videos

Product demos, reviews, and walkthroughs for aBSI.

View all on YouTube

Frequently Asked Questions

aBSI is an AI software solution designed for the quantitative assessment of bone scans. It helps physicians by automatically marking hotspots and quantifying disease burden, specifically the Bone Scan Index, which has been shown to be an independent prognostic determinant of overall survival in metastatic prostate cancer patients.
aBSI is developed with a focus on performance and safety. It also adheres to important data privacy regulations such as GDPR and HIPAA, ensuring patient data is handled securely and compliantly.
While the search results do not explicitly list direct AI alternatives, the traditional method for bone scan analysis involves manual assessment by radiologists. aBSI offers an automated, quantitative, and reproducible approach to disease burden assessment, potentially enhancing efficiency and consistency compared to manual methods.
Specific pricing details for aBSI are not publicly available in the provided information. Physicians interested in implementation would need to contact Exini Diagnostics AB directly for information on licensing, subscription models, or purchase costs, as well as potential integration fees.
While aBSI offers significant advantages, potential limitations could include the need for seamless integration with existing imaging systems like those from GE Healthcare and Siemens Healthineers, and ensuring staff training for optimal use. As with any AI tool, its effectiveness relies on the quality of input data and appropriate clinical interpretation.
aBSI is described as a validated AI software solution that provides accurate, quantitative, and reproducible assessments. It automatically updates the Bone Scan Index (BSI) value in real-time, even with editing of pre-selected hotspots, contributing to consistent results.
aBSI offers integrated solutions with major healthcare technology providers such as GE Healthcare and Siemens Healthineers. It is also available for local installation, suggesting flexibility in integration, but specific technical requirements would need to be discussed with the vendor.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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