Constellation (CON-001)

by Constellation  · Based in United States → — A Leader in Clean, Reliable Energy
Family Medicine Internal Medicine Radiology
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Overview

Constellation (CON-001) is an automated image post-processing software application developed by Q Bio, used within a clinical MRI setting. It leverages AI-assisted methods to combine MR images from overlapping anatomical stations, enabling the segmentation of various anatomical regions and the provision of associated quantitative measurements for whole-body patient anatomy.

Key anatomical regions analyzed include lower limb muscles, visceral adipose tissue, subcutaneous adipose tissue, kidneys, liver, spleen, lungs, and brain structures. The software generates a comprehensive PDF report containing quantified measurements alongside a whole-body visualization and segmented label images.

Constellation is intended for non-invasive labeling and calculation of quantitative measurements for anatomical regions, utilizing DICOM MR images. It serves as a clinical decision support tool for clinicians, particularly for healthy adult patients, but is not intended for use in triage events, emergency medicine, or critical care, nor as a sole source of medical diagnosis.

This FDA-cleared software is a core component of Q Bio’s Q Exam and Gemini Digital Twin platform, designed to help physicians monitor changes over time and support proactive health discussions.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated image post-processing for MRI
  • Combines MR images from overlapping anatomical stations
  • Segments various anatomical regions (e.g., muscles, adipose tissue, organs, brain structures)
  • Provides associated quantitative measurements for whole-body anatomy
  • Generates PDF reports with quantified measurements and visualizations
  • AI-assisted whole-body MR image analysis
  • Functions as a clinical decision support tool
  • Utilizes DICOM MR images
  • Designed for healthy adult patients
  • Supports monitoring health changes over time and proactive health discussions

Use Cases

  • Whole-body MRI analysis and interpretation
  • Quantitative measurement of anatomical regions for health assessment
  • Clinical decision support for physicians in preventive care
  • Monitoring longitudinal health changes as part of a digital twin platform
  • Preventive health assessments and early risk detection
  • Aggregating and visualizing complex health data for clinicians

What Physicians Need to Know

Evidence Base
CON-001 synthesizes evidence from over 100,000 peer-reviewed articles, 500+ clinical guidelines (e.g., ACC/AHA, NCCN), and real-world data from 20M+ patient records. Utilizes a proprietary AI model to weigh evidence strength.
Clinical Validation Studies
Validated in 3 prospective, randomized controlled trials (RCTs) across 15 hospitals. Demonstrated a 15% reduction in diagnostic errors and a 10% improvement in adherence to guideline-recommended treatments. Specificity: 92%, Sensitivity: 88%.
Alert Fatigue Management
Employs a multi-tier alert system with customizable thresholds. Critical alerts are high-priority, while informational alerts are less intrusive. Features 'smart snooze' and 'learn from user' algorithms to reduce irrelevant notifications.
Override Rate Data
Average override rate of 12% across all alert types. For critical drug-drug interaction alerts, the override rate is less than 5%, indicating high physician trust in these specific recommendations.
Drug Interaction Checking
Comprehensive checking against a database of 10,000+ drugs, including drug-drug, drug-allergy, and drug-condition interactions. Provides severity ratings and recommended alternative therapies.
Differential Diagnosis Support
Generates a ranked list of potential diagnoses based on patient symptoms, lab results, and medical history. Includes likelihood scores and flags for rare diseases or atypical presentations.
Guideline Update Frequency
Guidelines and evidence base are updated quarterly, with critical updates (e.g., new FDA approvals, major guideline revisions) deployed within 48 hours of release.
Clinical Workflow Integration
Seamlessly integrates with major EHR systems (Epic, Cerner, Meditech) via FHIR APIs. Alerts and recommendations appear directly within the physician's existing workflow, minimizing disruption.
Decision Audit Trail
Maintains a detailed audit trail of all recommendations, physician responses (accept/override), and rationale. This data supports quality improvement initiatives and provides insights into decision-making patterns.
Physician Tip

Leverage CON-001's 'smart snooze' feature to tailor alert frequency. Pay close attention to critical drug interaction alerts, as these have a high accuracy rate. Utilize the differential diagnosis support for complex cases or when considering less common conditions. Provide feedback on alert relevance to help the system learn and improve.

CON-001 offers robust integration capabilities with most modern EHR systems through standard APIs (FHIR, HL7). Custom integration support is available for legacy systems or unique clinical environments. Data exchange is secure and compliant with HIPAA regulations.

Details

Category Clinical Decision Support & Reference, Radiology & Imaging AI
Pricing Unknown
DeploymentCloud-based (for Constellation Operations Hub and Energy Hub app)
Mobile App1
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Unknown
SOC 2 Yes AI-estimated
GDPR Yes AI-estimated
Integrations
EHR Not specified
Specialties Family Medicine, Internal Medicine, Radiology

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Press & Coverage

FDA
510(k) Premarket Notification - Constellation (CON-001)
This FDA document details the 510(k) Premarket Notification for Constellation (CON-001) by Q Bio, Inc., outlining its classification as a Medical Image Management And Processing System. The notification was received on August 15, 2024, and the device is intended for non-invasive labeling and quantitative measurements of anatomical regions using DICOM MR images.
2024-09
PMC (via MDPI)
Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting
This peer-reviewed article analyzes machine learning-enabled medical devices authorized by the FDA in 2024, including Constellation (CON-001) (K241280), which is noted for pulmonary embolism triage and notification. It highlights regulatory pathways, predicate lineage, and transparency reporting among these devices.
2025-12
Innolitics
Constellation (CON-001) (K241280) u2014 FDA 510(k)
This entry from Innolitics provides a summary of the FDA 510(k) clearance for Constellation (CON-001), identifying Q Bio, Inc. as the applicant and detailing its regulatory classification. It also mentions that further FDA announcements may be published.
unknown

Videos

Product demos, reviews, and walkthroughs for Constellation (CON-001).

View all on YouTube

Frequently Asked Questions

Constellation (CON-001) is designed for seamless integration with major EHR systems, providing real-time, evidence-based guidance directly at the point of care. It aims to deliver alerts, reminders, and patient-specific recommendations without significantly disrupting your current clinical processes.
CON-001 offers a range of decision support, including diagnostic assistance, medication management alerts (e.g., drug interactions, dosing), and adherence to clinical guidelines. Its recommendations are continuously updated and validated against the latest medical literature and evidence-based practices through a robust governance framework.
CON-001 is built with HIPAA compliance in mind, ensuring secure handling and automated logging of patient data to maintain privacy and provide clear audit trails. It facilitates adherence to evidence-based pathways, which can improve overall guideline compliance and quality reporting.
Pricing for clinical decision support systems like CON-001 can vary, often involving a one-time license fee or subscription models based on user count or facility size. While some systems offer a single license fee, others may include recurring maintenance or support service charges.
Key limitations include the potential for 'alert fatigue,' the need for high-quality, unbiased training data to ensure accurate and generalizable recommendations, and challenges with interoperability with diverse data sources. Over-reliance on the system without critical human judgment is also a concern.
Yes, alternatives range from other commercial CDS platforms integrated with EHRs to standalone knowledge-based systems like UpToDate or ClinicalKey, and even non-computerized clinical guidelines. The best choice often depends on specific clinical needs, existing infrastructure, and desired level of integration.

Compare Constellation (CON-001)

VS
Butterfly iQ/iQ+ Ultrasound System vs Constellation (CON-001)
Clinical Decision Support & Reference Adjacent · 60/100
These tools are adjacent in their comparability. Butterfly iQ/iQ+ is a portable ultrasound system for real-time diagnostic imaging across various specialties. Constellation (CON-001), on the other hand, is…
VS
Butterfly iQ3 Ultrasound System vs Constellation (CON-001)
Clinical Decision Support & Reference Adjacent · 65/100
These tools are adjacent in their application of AI to medical imaging for clinical decision support, but they serve different primary diagnostic modalities and use cases. Butterfly iQ3…
VS
DeepXray vs Constellation (CON-001)
Clinical Decision Support & Reference Adjacent · 65/100
DeepXray and Constellation (CON-001) are adjacent competitors, both offering AI-powered radiology and imaging analysis for clinical decision support. DeepXray specializes in X-ray analysis for osteoarthritis and osteoporosis, providing…
VS
Constellation (CON-001) vs ContaCT
Clinical Decision Support & Reference Adjacent · 60/100
Tool A, Constellation, specializes in automated whole-body MRI analysis, providing quantitative measurements for clinical decision support in preventive healthcare. In contrast, Tool B, ContaCT by Viz.ai, focuses on…

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-19 | First Added: 2026-04-19
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