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

Related Content

Medical researchers at Flinders University have established a new link between high body mass index (BMI) and breast cancer survival rates — with clinical data revealing worse outcomes for early breast cancer (EBC) patients and improved survival rates in advanced breast cancer (ABC).

Getty Images

News | Women's Health | May 13, 2021
May 13, 2021 — Medical researchers at Flinders University
News | Artificial Intelligence | May 11, 2021
May 11, 2021 — Whiterabbit, an AI technology company focused on early...
A 37-year-old woman developed a new, palpable left supraclavicular lymphadenopathy lump five days after her first dose of the Moderna COVID-19 vaccine in the left arm. On the day of vaccination, the patient was asymptomatic. This is an example of how the vaccine can mimic cancer and swollen lymph nodes. Image used with permission of RSNA.

A 37-year-old woman developed a new, palpable left supraclavicular lymphadenopathy lump five days after her first dose of the Moderna COVID-19 vaccine in the left arm. On the day of vaccination, the patient was asymptomatic. This is an example of how the vaccine can mimic cancer and swollen lymph nodes. Read more about this case study. Image used with permission of RSNA.

Feature | Coronavirus (COVID-19) | May 03, 2021 | By Dave Fornell, Editor
While the mass COVID-19 vaccinat
A 63-year-old multiple #myeloma patient, with skeletal pain. New #FDG avid axillary #lymphadenopathy 62 days (9 weeks) after second #mRNA #vaccination dose. Image used with permission of the Radiological Society of North America (#RSNA)

A 63-year-old multiple myeloma patient, with skeletal pain. New FDG avid axillary lymphadenopathy 62 days (9 weeks) after second mRNA vaccination dose. Image used with permission of the Radiological Society of North America (RSNA)

Feature | Coronavirus (COVID-19) | April 29, 2021 | By Melinda Taschetta-Millane