Tuesday, June 30, 2026

FDA approves wearable 3D breast ultrasound for cancer screening


iSono Health’s ATUSA imaging system is the world’s first automated, wearable 3D breast ultrasound, the company said.

With 1 in 8 women developing breast cancer during their lifetime in the United States, and pathologists in short supply, there is a constant focus on improving techniques to increase the chances of early detection and survival.Now there is a company called iSono Healthdesigned to make personalized whole breast imaging accessible to all women worldwide, has received FDA clearance With its automated, wearable 3D breast ultrasound, the company announced on tuesday.

iSono says the technology, called ATUSA, is designed to be efficient, accurate and comfortable for both patients and physicians to use during their care.

According to the company, the portable system automatically scans the entire breast in just two minutes, requiring no operator expertise, and provides 3D visualization of breast tissue. The technology is integrated with machine learning models designed to provide clinical decision support.

The company said iSono was founded in 2016 by two female engineers who had similar personal experiences with the inadequacy of mammograms, especially for women with dense breasts.

“Mammograms have limited sensitivity for women with dense breasts, which are about half of those in the U.S.,” Maryam Ziaei, co-founder and CEO of the South San Francisco, California-based startup, said in an email. Say. “Ultrasound has been shown to be effective in increasing breast cancer detection rates in women with dense breasts.”

iSono is continuing to study ATUSA to demonstrate its effectiveness.

“We have demonstrated the safety and efficacy of the ATUSA device through extensive validation and validation testing and FDA-approved clinical feasibility studies,” Ziaei said. “However, we are conducting additional prospective studies.”

With the FDA approval of ATUSA, iSono joins other companies seeking to improve cancer detection through the use of artificial intelligence technology.

March, based in New York City Pagea startup spun out of Memorial Sloan Kettering Cancer Center to provide AI-based diagnostic software, launch software Helps detect breast cancer that has spread to the lymph nodes. The software, called Paige Breast Lymph Node, helps pathologists—Their numbers have been declining– in the time-consuming task of finding small tumors.other companies like Path AI and wild goat AI-driven decision support is also available to help doctors make accurate cancer diagnoses.

“Portable and automated whole breast ultrasound enhanced by machine learning will be the most practical technology to reduce breast cancer mortality globally, especially in resource-constrained countries,” said Dr. Mohammad Eghtedari, breast radiologist and assistant professor at the University of California, San Diego at iSono issued a statement in a press release. “Ultrasound has been shown to be effective as an adjunct to mammography in developed countries to improve breast cancer diagnosis in women with dense breasts.”

Eghtedari said she believes iSono’s automation and portable technology can help with both.

The technology will also provide another breast cancer screening option for young women who are ineligible for mammography or for women who don’t have access to mammograms, Ziaei said.

The American Cancer Society recommends that women with average breast cancer risk begin getting mammograms at age 45. The U.S. Preventive Services Task Force recommends starting breast cancer screening at age 50. For women considered to be at higher risk of breast cancer, and others who wish to start screening earlier, Experts recommend Begin by discussing the potential benefits and harms of not only screening but any subsequent treatment with your doctor.

Photo: iSono Health



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