Automated Wearable Breast Ultrasound System: Interview with Maryam Ziaei, CEO of iSono Health

iSono Health, a medtech company based in San Francisco, has created the ATUSA System, a wearable 3D ultrasound breast scanning system. The device is worn on the breast, and does not rely on operator experience or skill to obtain consistent, high quality breast scans.

As the scanning takes place automatically, it can be used by non-sonographers, such as medical assistants. The system also employs AI to assist in scan interpretation and treatment decisions.

The portable system can be used at the point of care, which may mean that it is suitable for use in remote or low resource parts of the world. As breast cancer is the leading cause of cancer death in women worldwide, improving access to high-quality scanning technology is important in helping to reduce breast cancer deaths.
The company recently announced that the ATUSA System has received FDA clearance for breast scanning. Medgadget had the opportunity to speak with Maryam Ziaei, CEO and co-founder of iSono Health, about the technology.

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Conn Hastings, Medgadget: Please give us an overview of breast imaging, and its importance in reducing breast cancer deaths.

Maryam Ziaei, iSono Health: Breast imaging encompasses various tools and techniques to screen, detect, and diagnose breast cancer. Many women will encounter some form of breast imaging as 1 in 8 women will be diagnosed with invasive breast cancer in their lifetime with breast cancer as the leading cause of cancer death among women worldwide. However, breast cancer has a 99% survival rate if detected early while it is still localized to breast tissue. Most deaths from breast cancer occur in unscreened or under-screened women, therefore regular monitoring of breast health can maximize survival rate.

Medgadget: What are the limitations of current breast imaging practices and technology?

Maryam Ziaei: Annual or biennial mammograms are the primary screening tool for breast cancer, but they have significant shortcomings for early breast cancer detection. Mammograms have limited sensitivity in women who have dense breasts, which is about half of all women in the US. Also, there are younger women who are not eligible for mammograms, or women who are not otherwise able to receive mammograms due to lack of access to a breast imaging center or fear of x-ray radiation. Due to limited access and/or frequency of office-based mammograms, many cancers are discovered in the interim period between screenings, and because of limited sensitivity, some are missed by mammograms entirely.

Ultrasound has been proven effective in improving breast cancer detection in women who have dense breasts and is the most cost effective, scalable and accessible solution worldwide. However, there is a high dependence on the operator’s skill to obtain good quality ultrasound images. Globally, there is a shortage of skilled ultrasound specialists that have limited wide implementation of handheld ultrasound systems for whole breast imaging. The ATUSA system enables automated whole breast imaging in a portable form factor that will improve access to millions of women worldwide with increased diagnostic capability, while allowing for shorter and more efficient screening.

Medgadget: What inspired you to develop this technology? How did it come about?

Maryam Ziaei: iSono Health was co-founded by two female engineers with PhDs who shared similar personal experiences with losing loved ones to breast cancer due to the inadequacies of mammograms, especially for women with dense breasts, that sparked the passion to find a better way for breast health monitoring. Additionally, women are told to do a self breast exam monthly to look for changes in their breast tissue; however, 90% of women don’t do self exam and the ones that do are not sure what changes are normal or abnormal. Therefore, the idea came about to develop a new and innovative system that uses ultrasound, which is a proven technology for breast imaging to see through the tissue and look for these changes more accurately and quantitatively.

Medgadget: Please give us an overview of the ATUSA System and how it works.

Maryam Ziaei: The ATUSA™ System is the first of its kind automated and wearable 3D breast ultrasound. The ATUSA scanner gets attached to a wearable accessory that positions the entire breast volume inside the field of view of the scanner. The system captures the entire breast volume by automatically scanning a linear transducer over the surface of the breast in just two minutes hands-free. The software will display the images real-time during the scan, and then it reconstructs and displays the 3D volumetric ultrasound images in various planes allowing the physician to annotate and create reports based on their findings. The software is designed to seamlessly integrate with the various machine learning algorithms to aid physicians with detection and classification of areas of interest.

Medgadget: How does the system reduce the need for operator expertise?

Maryam Ziaei: Globally, there is a shortage of skilled ultrasound specialists; and with conventional handheld ultrasound, there is a high dependency on the operator’s skill to obtain good quality ultrasound images. For example, the angle and the pressure the sonographer uses to place the probe on tissue to acquire an image can vary widely, therefore the captured image can be left up for interpretation. The ATUSA system enables automated breast imaging in a portable and compact form factor that is designed to provide hands-free image acquisition with operator agnostic image quality and allows the device to be operated by a non-sonographer such as a medical assistant. It also provides reproducibility of imaging, which is critical in breast imaging, and enables longitudinal monitoring of changes in breast tissue based on the patient’s own prior baseline. This has applications in high-risk patient monitoring, benign lesion follow ups as well as monitoring response to treatment for truly accessible, personalized breast care.

Medgadget: Are the 3D visualizations produced by the system valuable in identifying lesions that might otherwise be missed?

Maryam Ziaei: 3D visualization will help physicians view the tissue from different planes and further allow them to detect lesions that have grown in any arbitrary direction in the breast volume. Also, correlating the abnormality in various planes, specifically the coronal plane (which is not available in conventional 2D ultrasound), will certainly help physicians to detect and localize tissue abnormalities with higher precision.

Medgadget: How do you see these portable systems being used? Do you think this could have an impact in remote and/or low resource regions of the world?

Maryam Ziaei: The portability and automation of the ATUSA system will enable its use outside conventional clinical settings. The system can easily be used in remote or low resource settings such as a mobile unit or a rural community health center without the need for highly skilled sonographers. The ATUSA system was specifically designed to increase access to breast imaging to women no matter where they live so they don’t have to travel to a large city to access a breast imaging center.

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