Doctors Say New FDA-Approved Breast Cancer Screening Tool Using AI Won’t Replace Traditional Mammograms But Will Enhance Them

“This new approach can enhance the current standard of care,” Dr. Newell tells SurvivorNet.

Clairity Breast analyzes subtle patterns in screening mammograms linked to future breast cancer risk, generating a validated five-year risk score. This score is seamlessly integrated into clinical systems, enabling more personalized follow-up care.

“We can identify patients who are at elevated risk and offer supplemental screening to them with breast MRI or other technologies as a way to increase the likelihood of early detection. It does not replace mammography, and in fact, relies on mammographic images to allow the risk assessment,” she adds.

Dr. Elizabeth Comen explains how to do a self breast exam.

Currently, women at average risk are advised to begin yearly mammograms at age 40. While Clairity Breast does not change these guidelines, Dr. Newell noted that it could help identify patients who may need earlier screening or additional imaging methods.

“It may allow us to identify patients who should start screening at an earlier age if they are shown to be at elevated risk,” she said. “It can also allow us to identify patients who may benefit from supplemental screening technologies, in addition to their yearly mammogram, after the age of 40.”

Unlike AI programs designed to detect cancer directly from images, Clairity Breast functions as a risk assessment tool. It does not interpret mammograms for cancer detection but instead works alongside traditional methods to pinpoint patients who may be at higher risk.

“Other AI tools are being developed that provide assistance with interpretation, helping to detect a cancer that may already be present,” Dr. Newell explained. “But most of the literature to date suggests that AI tools work best when deployed in conjunction with interpretation by a breast radiologist.”

Clairity Breast represents a promising step in breast cancer prevention, offering a new layer of analysis that helps doctors identify high-risk patients early and refine screening approaches — all while keeping mammography at the core of detection.

How is 3D mammography different?

“Now, advancements in AI and computer vision can uncover hidden clues in mammograms — invisible to the human eye — to help predict future risk,” said Dr. Connie Lehman, founder of Clairity and breast imaging specialist at Mass General Brigham, in a press release.

Dr. Amani Jambhekar, a board-certified surgeon specializing in breast cancer and melanoma at CHRISTUS Health, says this new technology can make mammograms even more valuable.

“It may be a more individualized way of calculating breast cancer risk, which we need as existing risk calculators do not identify everyone who is high risk. As a surgical oncologist, I am excited to learn more about this platform when it launches,” Dr. Jambhekar tells SurvivorNet.

RELATED: When Should I Get a Mammogram?

What To Know About Enhanced Mammograms

Enhanced mammograms are a helpful tool for women whose breast tissues obscure precise mammography readings. While implants often call for enhanced mammogram screening, women with dense breasts may also need enhanced screening. Dense breasts mean more fibroglandular tissue and less fatty breast tissue.

During mammograms, the tissue difference can make locating signs of cancer more difficult in women with dense breasts.

Additional testing can be considered for these women, depending on her personal history, preferences, and her physician’s guidance.

These tests include:

• 3-D Mammogram (Breast Tomosynthesis): This technology acquires breast imaging from multiple angles and digitally combines them into a 3D representation of the breast tissue. This allows physicians to see breast tissue architecture better, even in dense breasts. 3D mammograms are fast becoming the standard way of performing mammography.
• Breast Magnetic Resonance Imaging (MRI): An MRI machine uses magnets to create highly detailed, intricate images of the breast. These are mostly reserved for women with an extremely high breast cancer risk. Dense breasts alone may not be a valid reason to obtain a breast MRI. However, dense breasts in women with genetic mutations, like BRCA1 and BRCA2, or a strong family history of breast cancer could justify obtaining breast MRIs.
• Molecular Breast Imaging (MBI): MBI is a newer imaging technique that uses a radioactive tracer to detect breast cancer. It is beneficial for women with dense breasts. However, MBI is not as widely available as other screening methods.

When you’re getting a mammogram, ask about dense breasts.

Understanding Your Mammogram Report

A radiologist reading mammograms categorizes breasts into four different categories using the Breast Imaging Reporting and Data System (BI-RADS), a classification system developed by the American College of Radiology (ACR).

These include:

• Fatty breast tissue: These breasts are mainly fat with very little dense tissue. Found in less than 10% of women, fatty breasts appear dark on mammograms.
• Scattered fibroglandular breast tissue: These breasts contain a mix of fatty and dense tissue (composed of glands and fibrous tissue). On a mammogram, they have dark areas (fatty tissue) intermixed with light areas (dense tissue). Around 40% of women have breasts that fall in this category.
• Heterogeneously dense breast tissue: This type of breast tissue has many areas of dense tissue and some areas of fat. Found in 40% of women, these breasts look mostly light, with some dark areas on a mammogram.
• Extremely dense breast tissue: Such breasts are almost entirely composed of dense glandular and fibrous connective tissues with very little fat. They are found in 10% of women and appear light on mammograms.

Your breasts are usually called dense on a mammogram report if they fall within the heterogeneously dense breast tissue or the extremely dense breast tissue categories.

When To Screen For Breast Cancer

Recently, an independent panel of experts called the U.S. Preventive Services Task Force (USPSTF) upgraded its guidelines to suggest that women start getting mammograms every other year at the age of 40. The task force notes that this lowered the age (the previous recommendation was to begin screening at age 45) for breast cancer screening could save 19% more lives.

The American Cancer Society recommends getting a mammogram every other year for women 55 and older. However, women in this age group who want added reassurance can still get annual mammograms.

Mammograms are still the best tool for detecting breast cancer.

Women with a strong family history of breast cancer, a genetic mutation known to increase the risk of breast cancer, such as a BRCA gene mutation, or a medical history, including chest radiation therapy before the age of 30, are considered at higher risk for breast cancer.

Experiencing menstruation at an early age (before 12) or having dense breasts can also put you into a high-risk category. If you are at a higher risk for developing breast cancer, you should begin screening earlier.

Questions To Ask Your Doctor

If you have a breast cancer screening coming up or recently had one, you may have questions you want answered. SurvivorNet suggests the following questions to kickstart your conversation with your doctor.

• Do I have dense breasts?
• Do I need to undergo additional or more sensitive screening?
• How is my risk level being assessed?
• Will insurance cover additional screening if needed?

Learn more about SurvivorNet's rigorous medical review process.

---