When one out of every eight women in the US develops breast cancer and at the same time the number of pathologists is decreasing, the need to develop contemporary technology that will enable early detection of breast cancer is increasing. The newspaper “MedCity News” It was published on May 3, 2022 that the company ISono Health Received FDA approval for an automated, wearable, 3D ultrasound device designed to make personalized breast imaging accessible.
According to the company’s statement, the innovative device (ATUSA) will be efficient, accurate and convenient, and is designed to be accessible to patients and doctors at the point of treatment.
In just two minutes, the system automatically scans the entire breast, regardless of the operator’s expertise, and offers a three-dimensional imaging of the breast tissue. The technology incorporates machine learning models and aims to provide clinical support in decision-making.
iSono was founded in 2016 by two female engineers who shared similar personal experiences of not being suitable for a mammogram (a test for the identification and early diagnosis of suspicious tissue in the breast area), especially for women with “dense breasts” (a term referring to a condition where most of the breast tissue is mainly made of connective tissue gland and very little adipose tissue).
“Mammography has limited sensitivity in diagnosing women with ‘dense breasts’, which is about half of all women in the US,” said Maryam Ziaei, co-founder and CEO of the South San Francisco, California-based startup. “Ultrasound has been shown to be effective In improving the detection of breast cancer in women with dense breasts”.
“We have demonstrated the safety and efficacy of the ATUSA device with extensive verification and validation testing, as well as clinical feasibility studies to obtain FDA approval,” Ziayi said. “However, we are conducting further prospective studies.”
