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

San Francisco-based medical technology company iSonoHealth has created the ATUSA system, a wearable 3D ultrasonic breast scanning system. The device is mounted on the breast and does not rely on the operator’s experience or skills to obtain a consistent, high quality breast scan.

The scan is automatic and can be used by non-ultrasound examiners such as medical assistants. The system also employs AI to assist in interpreting scans and making treatment decisions.

The portable system can be used at the Point of Care. In short, it may be suitable for use in remote and resource-poor areas of the world. Breast cancer is the leading cause of cancer deaths in women around the world, so improving access to high-quality scanning techniques is important to reduce breast cancer deaths.

The company recently announced that the ATUSA system has received FDA approval for breast scans. Medgadget I had the opportunity to talk about technology with Maryam Ziaei, CEO and co-founder of iSono Health.

Conn Hastings, Medgadget: What is the overview of breast imaging and its importance in reducing breast cancer mortality?

Maryam Ziaei, iSono Health: Breast diagnostic imaging includes a variety of tools and techniques for screening, detecting, and diagnosing breast cancer. Many women have some form of breast image because one in eight women is diagnosed with invasive breast cancer in their lifetime and breast cancer is the leading cause of cancer death in women around the world. Encounter. However, breast cancer has a 99% survival rate if detected early while confined to breast tissue. Most breast cancer deaths occur in unscreened or unscreened women, so regular monitoring of breast health can maximize survival.

Medgadget: What are the limits of current breast imaging practices and techniques?

Maryam Ziaei: Although annual or biennial mammograms are the primary screening tool for breast cancer, they have significant drawbacks for early detection of breast cancer. Mammograms have limited sensitivity to women with dense breasts. This is about half of all women in the United States. Others may not be eligible for the mammogram, or may not be able to receive the mammogram due to lack of access to the breast imaging center or fear of x-rays. Due to limited access and frequency of office-based mammograms, many cancers are found during the interim period between screenings, and some cancers are completely overlooked by mammograms due to their limited sensitivity.

Ultrasound has proven to be effective in improving breast cancer detection in women with dense breasts and is the most cost-effective, scalable and accessible solution in the world. However, obtaining high quality ultrasound images depends heavily on the skill of the operator. Globally, there is a shortage of skilled ultrasound specialists limiting the widespread implementation of handheld ultrasound systems for imaging the entire breast. The ATUSA system enables automated full breast imaging in a portable form factor, improving diagnostic capabilities and improving access to millions of women worldwide, while enabling shorter and more efficient screening. increase.

Medgadget: What made you decide to develop this technology? How did that happen?

Maryam Ziaei: iSono Health was co-founded by two PhD female engineers who shared a similar personal experience of losing a loved one to breast cancer, especially due to inadequate mammograms for women with dense breasts. A passion for finding better ways for your health monitoring. In addition, women are told to do a monthly self-breast examination to look for changes in breast tissue. However, 90% of women do not self-examine and women are not sure what changes are normal or abnormal. That led to the idea of ​​developing a new and innovative system that uses ultrasound. This is a proven technique for seeing through tissue in breast imaging and looking 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 this type of automated wearable 3D breast ultrasound. The ATUSA scanner is attached to a wearable accessory that places the entire breast volume within the scanner’s field of view. The system captures the volume of the entire breast by automatically scanning a linear transducer on the surface of the breast in just two minutes hands-free. The software displays the image in real time during the scan, then reconstructs the 3D volumetric ultrasound image and displays it on various planes, allowing the doctor to annotate and report based on the findings. The software is designed to integrate seamlessly with various machine learning algorithms to help physicians detect and classify 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. In addition, traditional handheld ultrasound relies heavily on the operator’s skills to obtain high quality ultrasound images. For example, the angle and pressure used by an ultrasound examiner to place a probe in a tissue to obtain an image can vary significantly, so the captured image can be left for interpretation. increase. The ATUSA system enables automated breast imaging in a portable and compact form factor designed to provide hands-free image acquisition with operator-independent image quality, allowing non-ultrasound examiners such as medical assistants to operate the device. make it possible. It also provides important imaging reproducibility in breast imaging, allowing longitudinal monitoring of changes in breast tissue based on the patient’s own previous baseline. It applies to monitoring high-risk patients, follow-up of benign lesions, and monitoring response to truly accessible, personalized breast care treatments.

Medgadget: Does the system-generated 3D visualization help identify lesions that could otherwise be missed?

Maryam Ziaei: 3D visualization helps doctors view tissue from different planes and also allows them to detect lesions that have grown in any direction of the breast volume. Also, by correlating abnormalities in various aspects, especially the coronal plane (not available with traditional 2D ultrasound), physicians can more accurately detect and identify tissue abnormalities.

Medgadget: How do you think these portable systems are used? Do you think this could affect remote and resource-poor areas of the world?

Maryam Ziaei: The portability and automation of the ATUSA system allows it to be used outside of traditional clinical settings. The system is easy to use in remote or low resource configurations such as mobile units and local community health centers without the need for highly skilled sonographers. The ATUSA system is specially designed to increase access to breast images wherever women live, so you don’t have to travel to a big city to access a breast imaging center.

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

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