News | Breast Imaging | April 23, 2021

FDA Clears Imagio P200003 Breast Imaging System

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

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