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Pioneering Change in Breast Cancer Detection: Dr. James Hugg and SmartBreast

The facts surrounding mammogram screening can be shocking.

Even though mammograms are the most widely used breast cancer screening test and save many lives, the American Cancer Society reveals that “Mammograms have their limits…Women with dense breasts are more likely to get false-negative results.” Women may have cancer, but their mammograms will fail to discover it because dense breast tissue often hides cancer.

According to, “If you do have dense breasts, a mammogram will find LESS THAN 50% of cancers.” About half of women have dense breasts.

This alarming data inspired the launch of SmartBreast, the first and only company focused on offering solutions specifically for women with dense breasts. The mission of SmartBreast is early diagnosis of harder-to-detect cancer in dense breasts, significantly improving patient outcomes and thereby saving breasts and lives.

“The high failure rate of mammography for depicting early-stage cancer in dense breasts, the elevated risk for cancer, and the resulting large number of late-stage interval cancers (diagnosed between annual screening mammograms that appear normal) constitute ‘the dense breast problem,’ which brought together our world-renowned team of medical imaging scientists, breast surgeons, and radiologists dedicated to defeating cancer in dense breasts,” reads

Delays in breast cancer diagnosis, sometimes by four to six years, increase the need for radical surgeries, including mastectomies, chemotherapy, immunotherapy, and radiation therapy.  Later diagnosis also results in a much lower life expectancy than if cancer is detected early.

SmartBreast co-founder and CEO James Hugg, PhD, MBA, is well-positioned to address the critical issues presented by the failure of mammography to identify cancer in dense breasts. As a medical physicist, he has held senior positions at medical imaging companies, including General Electric Healthcare and Gamma Medica. He led the GE Healthcare team that developed the imaging technology behind Molecular Breast Imaging (MBI).

MBI solves the dense-breast diagnosis problem with its ability to see through dense tissue. MBI spotlights cancers with a low-dose tracer that concentrates in cancer cells and, unlike mammography, is painless.

Playing a pivotal role in Dr. Hugg’s inspiration was his wife and her experience with mammograms.

“I always give my wife credit,” said Dr. Hugg, who holds 20 patents. “She told me about the awful experience of having her breasts mashed during a mammogram and then being called back for additional tests and biopsies. And these unpleasant tests still miss most early-stage cancers in women with dense breasts.”

After leading the GE Healthcare team in developing the technology that made MBI possible, the opportunity arose to acquire and grow their MBI product line. James and his co-founders formed SmartBreast, raised $2.4 million during the pandemic, and negotiated a robust deal with GE. After SmartBreast grows the MBI market, GE wants to repurchase the MBI product line.

Dr. Hugg sees great market potential in Asia, where 70% of women have dense breasts. Specifically, India and China represent untapped markets for SmartBreast technology.

But the U.S. represents an even greater opportunity.

The potential for SmartBreast’s success in the U.S. accelerated on March 9, 2023, when the FDA officially acknowledged the dense-breast problem with its mandate for supplemental screening of women with dense breasts. Additionally, the Congressional “Find It Early Act” would require full payment by insurance companies of the supplemental dense-breast screening cost.

“Our timing right now,” Dr. Hugg said, “couldn’t be better.”

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