syngo MBF

by Siemens Medical Solutions USA, Inc.  · Based in United States →AI-enhanced quantitative myocardial blood flow analysis for PET imaging.
Cardiology Nuclear Medicine Radiology

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Regulatory Status Disclosed

Overview

syngo MBF, developed by Siemens Medical Solutions USA, Inc., is a specialized software product designed for the visualization, assessment, and quantification of medical images, specifically focusing on quantitative blood flow measurements from Positron Emission Tomography (PET) images. This software operates within the MI Cardiology workflow of the broader syngo.via MI Workflows platform. It supports dynamic Rubidium-PET and dynamic Ammonia-PET images, providing clinicians with automatic and manual tools to orient and segment the myocardium. The system calculates myocardial blood flow and offers features like a normals database comparison workflow to aid in the assessment of results.

As part of the syngo.via platform, syngo MBF benefits from advanced visualization capabilities and AI-enabled features. The syngo.via platform utilizes ALPHA (Automatic Landmarking and Parsing of Human Anatomy) technology, an AI component that automatically recognizes anatomical landmarks in acquired images to accelerate reading workflows. The platform is designed for multi-modality reading, delivering fast 3D results, and enhancing diagnostic performance across various clinical fields including cardiology, oncology, and neurology. syngo.via can be integrated into existing IT environments, supporting both dedicated hardware and virtualized deployments. It also offers a subscription model for flexible access to clinical packages and continuous software innovations.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Quantitative Myocardial Blood Flow (MBF) and Myocardial Flow Reserve (MFR) calculation
  • Supports dynamic Rubidium-PET and Ammonia-PET images
  • Automatic and manual myocardium orientation and segmentation tools
  • Normals database comparison workflow
  • Motion compensation and residual activity correction
  • Multi-modality image reading (via syngo.via platform)
  • AI-powered Automatic Landmarking and Parsing of Human Anatomy (ALPHA) for workflow acceleration (via syngo.via platform)
  • Fast 3D results and advanced visualization
  • Structured reporting capabilities
  • Integration with Siemens Healthineers Digital Ecosystem via OpenApps

Use Cases

  • Myocardial blood flow quantification in PET imaging
  • Assessment of cardiac pathologies
  • Evaluation of patient response to therapy
  • Cardiac function analysis
  • Diagnostic workflow enhancement in nuclear cardiology
  • Radiotherapy treatment planning (images and results can be used)

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Contact vendor Contact Vendor for details.
DeploymentOn-premise (dedicated hardware), Virtualized environments (VMware, Hyper-V)
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

syngo MBF, as part of syngo.via MI Workflows, received FDA 510(k) clearance (K251528) on July 3, 2025, as an automated radiological image processing software for visualization, assessment, and quantification of medical images, specifically for quantitative blood flow measurements of PET images.

Integrations
EHR Not specified
Specialties Cardiology, Nuclear Medicine, Radiology

What the Web Says

syngo MBF, a software component within Siemens Healthineers' syngo.via MI Workflows, is designed for advanced post-processing and quantitative analysis of multi-modality medical images, particularly in cardiology for myocardial blood flow (MBF) and coronary flow reserve (CFR) quantification. Physicians and researchers generally find it to be a valuable tool for quantitative analysis in nuclear cardiology, with good to excellent reproducibility for rest-MBF values. However, some studies indicate suboptimal agreement for stress-MBF and CFR values without motion correction. It is FDA-approved and utilizes compartmental modeling for kinetic analysis.

Overall: Positive

Strengths

  • Provides advanced post-processing and quantitative analysis of multi-modality medical images (PET, CT, MR, NM).
  • Supports clinical decision-making in oncology, cardiology, neurology, and radiotherapy planning.
  • Offers good or excellent reproducibility for rest-MBF values.
  • Can be used for myocardial blood flow (MBF) and myocardial flow reserve (MFR) quantification.
  • Integrates with the syngo.via platform for a consistent user experience across different modalities and isotopes.
  • Includes features like pre-fetching, ALPHA technology for organ recognition and alignment, and smart layouts to streamline workflow.

Limitations

  • Suboptimal agreement for stress-MBF and CFR values without motion correction, though motion correction tools can improve reproducibility.
  • Reproducibility for certain cardiac tracers can be challenging.
  • Some studies have shown statistically significant differences in myocardial perfusion analysis when compared to other software packages.
  • Interchangeability with other software tools may be limited in specific patient populations or for certain measurements.
  • Training for syngo.via (which includes syngo MBF) may not always be sufficient, requiring users to seek additional resources.
  • The software can be complex and may not be user-friendly without proper guidance.

Based on reviews from: ResearchGate, Science.gov, ScienceDirect, FDA AI/ML Device Search, Diagnostics, Volume 15, Issue 5, DOKUMEN.PUB, accessdata.fda.gov, PMC, MDPI, Open Heart, Innolitics, Which Medical Device, Siemens Healthineers USA, KLAS Research, Reddit

Last updated: 2026-07-20

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Press & Coverage

FDA.gov
syngo.via MI Workflows; Scenium; syngo MBF 510(k) Clearance
Siemens Medical Solutions USA, Inc. received 510(k) clearance for syngo.via MI Workflows, including Scenium and syngo MBF applications, a multi-modality post-processing software for managing diseases in oncology, cardiology, neurology, and organ function. The software, with versions VC10 for syngo.via MI Workflows, VE70 for Scenium, and VB30 for syngo MBF, offers enhanced functionality while maintaining the same intended use and fundamental scientific technology as its predicate device.
2025-07
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances
This review of 2025 AI/ML-related FDA clearances highlights Siemens Medical Solutions USA, Inc.'s syngo.via MI Workflows, Scenium, and syngo MBF among the cleared devices. The report notes that image-processing and workflow software product codes were dominant, with a significant focus on coronary CT tools.
2026-01
Frontiers in Cardiovascular Medicine
Simultaneous 13N-ammonia and gadolinium perfusion using integrated PET-MRI: diagnostic accuracy in coronary microvascular dysfunction
This peer-reviewed article discusses the use of Syngo MBFu00ae (Siemens Healthcare) software for semi-automatic quantification of PET data in simultaneous 13N-ammonia PET and gadolinium perfusion MRI scans. The study aimed to evaluate diagnostic accuracy in coronary microvascular dysfunction, finding moderate correlation between MRI and PET measurements of global rest and stress MBF.
unknown
MDPI (Journal of Nuclear Medicine Reports)
Inter-Software Reproducibility of Quantitative Values of Myocardial Blood Flow and Coronary Flow Reserve Acquired by [13N]NH3 MPI PET/CT and the Effect of Motion Correction Tools
This peer-reviewed article investigates the inter-software reproducibility of myocardial blood flow (MBF) and coronary flow reserve (CFR) values using different software packages, including syngo.MBF (Siemens Healthineers). The study found good or excellent reproducibility for rest-MBF values, but only moderate agreement for stress-MBF and CFR values without motion correction.
2025-03
Circulation Journal
Clinical Effects of Supervised Cardiac Rehabilitation in Patients With Angina and Non-Obstructive Coronary Artery Disease and Impaired Myocardial Flow Reserve
This study utilized the Syngo MBF software package (Siemens Healthcare) for quantitative PET analysis to assess stress/resting MBF and MFR in patients with angina and non-obstructive coronary artery disease. The research concluded that exercise-based cardiac rehabilitation significantly improved MFR, symptom status, and exercise capacity in these patients.
2025-04
Diabetes Care
Increased Subclinical Coronary Artery Pathology in Type 2 Diabetes With Albuminuria
This cross-sectional study used Syngo.via software (syngo.mbf vb20a) to automatically measure myocardial blood flow in patients with type 2 diabetes. The research aimed to evaluate subclinical coronary artery pathology using multimodal imaging, including 82Rb PET/CT.
2023-11
PMC (from Journal of Nuclear Cardiology)
Multi-task Deep Learning of Myocardial Blood Flow and Cardiovascular Risk Traits from PET Myocardial Perfusion Imaging
This article details the use of Syngo MBF software (Siemens Medical Solutions) for automatic assignment of left ventricular contours and computation of stress MBF, rest MBF, and myocardial flow reserve (MFR) values from PET myocardial perfusion imaging. The study explores multi-task deep learning for predicting cardiovascular risk traits.
2022-01
ResearchGate (Journal of Nuclear Cardiology)
The continual innovation of commercial PET/CT solutions in nuclear cardiology: Siemens Healthineers
This article highlights Siemens Healthineers' sophisticated solution for calculating myocardial blood flow (MBF) and myocardial flow reserve (MFR), implemented in 2009. It emphasizes the integration of innovative scanner and image-processing technology into an efficient workflow for cardiac PET/CT.
2018-04

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