IMAGIO® | Reducing negative biopsies
No one wants to miss a cancer.
Clinical studies of the Imagio® Breast Imaging System have demonstrated:
- Greater confidence in determining whether a mass is benign or malignant1
- Increased specificity to more than 50 percent2, with no significant loss of sensitivity
- Better visualization of presence, absence and morphology of tumor neoangiogenesis than mammography or CDU
Getting Started
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Current diagnostic workflow3
1st Procedure
Diagnostic Mammogram
100% of those patients
Diagnostic Mammogram
100% of those patients
Lack of specificity in these modalities creates the need for additional diagnostic exams, many of which are inconclusive.
Scenario: Screening indicates a mass
Scenario: Screening indicates a mass
2nd Procedure
Ultrasound
48.4% of those patients
Ultrasound
48.4% of those patients
Scenario: Further screening sought
3rd Procedure
CESM, PEM, MBI
20.1% of those patients
CESM, PEM, MBI
20.1% of those patients
Modalities that have higher specificity, but also involve invasive clinical risks.
4th Procedure
MRI
10% of those patients
MRI
10% of those patients
Modalities that have higher specificity, but also involve invasive clinical risks.
Scenario: Finally, diagnosis confirmed with a biopsy.
Scenario: Finally, diagnosis confirmed with a biopsy.
1st Procedure
Diagnostic Mammogram
100% of those patients
Diagnostic Mammogram
100% of those patients
Lack of specificity in these modalities creates the need for additional diagnostic exams, many of which are inconclusive.
Scenario: Screening indicates a mass
Scenario: Screening indicates a mass
2nd Procedure
Ultrasound
48.4% of those patients
Ultrasound
48.4% of those patients
Scenario: Further screening sought
3rd Procedure
CESM, PEM, MBI
20.1% of those patients
CESM, PEM, MBI
20.1% of those patients
Modalities that have higher specificity, but also involve invasive clinical risks.
4th Procedure
MRI
10% of those patients
MRI
10% of those patients
Modalities that have higher specificity, but also involve invasive clinical risks.
Scenario: Finally, diagnosis confirmed with a biopsy.
Scenario: Finally, diagnosis confirmed with a biopsy.
Higher confidence creates simplified and streamlined clinical pathways.
On average, 70-80% of biopsies are false positive — wasting precious resources and increasing patient anxiety. Imagio® has the potential to reverse the negative biopsy ratio without missing cancer. Imagio® has the potential to bypass many of the additional, inconclusive exams to reach a definitive diagnosis.
Real Feedback. Real Results.
“Especially in large markets and large cities, where hospital systems compete against each other, it's nice to be able to say that our radiology practice offers the newset technology, including cutting-edge opto-acoustic imaging. When it comes to healthcare, women seek out technologies that can help them. This could be one.”
AI-based decision support
Accurately assign diagnostic BI-RADS
Proven to make clinicians more accurate, our proprietary SenoGram® provides AI-driven decision support in assessing likelihood of malignancy (LOM).References
- Results from MAESTRO Study of BI-RADS 4a and 4b.
- Results from Reader-02 Study.
- Vlahiotis A, Griffin B, Stavros AT, Margolis J. Analysis of Utilization Patterns and Associated Costs of the Breast Imaging and Diagnostic Procedures After Screening Mammography. ClinicoEconomics and Outcomes Research 2018:10 157-167.
- EUSOBI 2022 Interim CONFIDENCE Registry Results.
- Seiler SJ, Neuschler EI, Butler RS, Lavin PT, Dogan BE. Optoacoustic imaging with decision support for differentiation of benign and malignant breast masses: A 15-reader retrospective study. AJR Am J Roentgenol. December 7, 2022.