The Imagio Breast Imaging System combines laser light and sound with conventional ultrasound technology to provide fused functional and anatomic images (referred to as optoacoustic/ultrasound or OA/US) in real time, increasing confidence in diagnostic accuracy.

The Imagio Breast Imaging System combines laser light and sound with conventional ultrasound technology to provide fused functional and anatomic images (referred to as optoacoustic/ultrasound or OA/US) in real time, increasing confidence in diagnostic accuracy.


April 23, 2021 — The U.S. Food and Drug Administration (FDA) has approved Seno Medical's Imagio P200003 Breast Imaging System

The Imagio Breast Imaging System uses both optoacoustic (OA) and ultrasound (US) to image breast tissues to help physicians examine breast lesions. The Imagio Breast Imaging System has software and hardware that produces OA images and conventional ultrasound images of the breast. First, ultrasound mode is used initially to assess any focal area(s) of clinical or imaging concerns. For ultrasound BI-RADS 3-5 masses, using the OA images allows for improved classification compared to ultrasound alone. The OA mode is not indicated for ultrasound BI-RADS 1 and 2 findings. The Imagio® Breast Imaging System includes an artificial intelligence (AI) based software function to assist the users with BI-RADS classifications.

The Imagio Breast Imaging System is used when a physician finds an unusual area of breast tissue using mammography and ultrasound. The OA images generated using this device are used to evaluate breast lesions. The OA images generated using Imagio Breast Imaging System could provide more information on the region of breast being imaged such as the structure and function (e.g., blood oxygen level) comparing to ultrasound images alone. This additional information for ultrasound BI-RADS 3-5 masses could help physicians in evaluating breast lesions and assessing BI-RADS classifications.

The Imagio Breast Imaging System should not be used in people who:

  • Are pregnant
  • Have open sores like insect bites, rash, poison ivy, or scratches on the skin on the side of the breast)
  • Are experiencing effects like phototoxicity (irritation due to light) because of taking drugs such as sulfonamidesampicillintetracycline within the last 72 hours
  • Are going through phototherapy
  • Have a history of any photosensitive disease (e.g., porphyrialupus erythematosus)
  • Are being treated for a photosensitive disease or are experiencing photosensitivity

For more information: https://senomedical.com


Related Content

Feature | Radiology Imaging

View the September/October digital edition of Imaging Technology News (ITN), including links to videos, comparison ...

Time September 29, 2022
arrow
News | Radiation Oncology

September 28, 2022 — Populations in U.S. counties defined as more vulnerable based on social factors including ...

Time September 28, 2022
arrow
News | Breast Imaging

September 26, 2022 — The U.S. Food and Drug Administration (FDA) has granted QT Imaging, Inc. 510(K) clearance to ...

Time September 26, 2022
arrow
News | Breast Density

September 22, 2022 — DenseBreast-info.org (DB-i) announced that it will host the inaugural #WorldDenseBreastDay on ...

Time September 22, 2022
arrow
News | Ultrasound Women's Health

September 21, 2022 — Butterfly Network, Inc. (NYSE: BFLY), a digital health company transforming care through the power ...

Time September 21, 2022
arrow
Feature | Breast Imaging | By Christine Book

Findings from a clinical trial that used artificial intelligence (AI) in an effort to reduce false positives on breast ...

Time September 21, 2022
arrow
News | MRI Breast

September 16, 2022 — According to ARRS’ American Journal of Roentgenology (AJR), the contrast-enhanced in-phase Dixon ...

Time September 16, 2022
arrow
Feature | Ultrasound Women's Health | By Roberta Kline, MD and Robert L. Bard, MD, DABR, FASL

An estimated 24% of women in the United States will suffer from a pelvic floor disorder in her lifetime, with that ...

Time September 15, 2022
arrow
News | Breast Imaging

September 14, 2022 — When double reading screening mammograms, radiographers (technologists) trained for the task ...

Time September 14, 2022
arrow
News | Ultrasound Imaging

September 9, 2022 — Boston Imaging, the United States headquarters of Samsung digital radiography and ultrasound ...

Time September 09, 2022
arrow
Subscribe Now