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ClariSIGMAM

  • Breast Density
  • Digital mammography
  • X-Ray (2D)
  • Mammography

ClariSIGMAM automatically analyzes “for presentation” 2D digital mammograms to assess breast tissue composition. The software assesses the breast density of women and generates a breast density group information for the patient in accordance with the American College of Radiology’s Breast Imaging Reporting and Data System (BI-RADS) 5th edition density classification scale.

Claripi

Images shown for illustrative purposes only.

Circle

~29% and ~21% improved nodules detection

Riverain's AI suppression technology removes structures that can camouflage cancer and lung disease. 1,2

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~26% and ~20% faster nodule search time

ClearRead CT technology helps radiologists see through the complexity to better detect abnormalities.1,2

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Higher inter-reader agreement rates2

Clinical Workflow

clearread workflow

For CalanticTM software version 1.0.0 and older versions, no prior study will be examined.

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    Scanning Parameters

    2D digital mammograms Series: cranio-caudal (CC)or medio-lateral oblique (MLO)

    AI Output

    The report summarizes the results of the breast density analysis. It contains patient information, mammography images with a pink overlay, and tables displaying results that includes:

     

    • Breast area (cm2) for each breast
    • Fibroglandular tissue area (cm2) for each breast
    • Percent breast density for each breast
    • Breast Density Category according to the BI-RADS 5th edition.

    What Customers Are Saying

    The application enables identification of small nodules faster and more reliably, particularly for oncological patients.

    Terence Matalon, MD, Chairman of Einstein Medical Center Philadelphia’s Department of Radiology.

    May not reflect a typical user experience; actual results may vary.

    What Customers Are Saying

    ClearRead CT technology has helped us to detect lung nodules that may have otherwise been missed.

    Jared Christensen MD, MBA, Cardiothoracic Imaging at Duke University Medical Center.

    May not reflect a typical user experience; actual results may vary.

      Other Relevant Information

      Currently not made available with Calantic Viewer. Separately distributed by Bayer.

       

      EU risk class and CE marking
      ClariSIGMAM has CE marking (CE2460) and risk class Im.

      Reimbursement status
      Not reimbursed.

      Contraindications
      No contraindications given.

      Target population
      Not indicated.

      Intended user
      Trained and experienced medical professionals including but not limited to radiologist and radiology technologist.

      Limitations
      To ensure correct results are received and for avoidance of doubt, ClariSIGMAM cannot be used on the following images (note that this is not an exhaustive list):

      • ‘For processing’ mammography images.
      • Contrast enhanced mammography images.
      • Cleavage views.
      • Medial Lateral or Lateral Medial views.
      • Image including implants.
      • Spot or Magnification views.
      • Images obtained with a small compression paddle that results in breast tissue being obstructed by compression device frame or tissue outside of compression paddle.
      • Images including guidance wires or markers.

       

      If any of these images are processed with ClariSIGMAM, erroneous results may be generated.

        References
        1.
        Instructions for Use ClariSIGMAM, software version 1.1
        App gallery wave image
        Discover ClearRead CT

        Discover CLARISIGMAM

        Now available as part of Calantic’s Breast Service Line. Contact us today to learn more.

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        Other Offerings in the Breast Service Line

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