A medical imaging startup first incubated within Sheba’s innovation ecosystem, PinkStar has entered an agreement with Mount Sinai Health System set to advance breast MRI protocols and support early cancer detection. The partnership marks PinkStar's first collaboration with a U.S. academic medical institution.

Breast MRI ranks among the most precise methods available for detecting breast cancer, particularly in women at high risk for the disease. Analyzing these scans, however, remains a time-consuming task for radiologists. Sheba’s ARC Innovation has been making significant strides toward reducing this bottleneck in recent years, an effort that gave rise to PinkStar and its AI-driven approach to breast MRI interpretation.

As PinkStar’s CEO Sivan Sadan explained, the technology is ultimately centered on a clear clinical objective: “PinkStar is developing AI technologies for breast MRI, and our goal is early detection of breast cancer.”

Inside the Collaboration

PinkStar’s AI system, developed using the clinical expertise and imaging data of Sheba Medical Center, is designed to characterize suspicious findings on breast MRI and assist in detection of early-stage lesions. Under the terms of the new partnership, Mount Sinai has agreed to provide clinical data to help train and validate PinkStar’s technology. 

Dr. Laurie Margolies, Prof. of Radiology at the Icahn School of Medicine at Mount Sinai and Vice Chair for Breast Imaging, and Dr. Elisa Port, Chief of Breast Surgery at Mount Sinai Health System, will lead the New York-based hospital network’s side of the clinical partnership through the Tisch Cancer Center and its Center of Excellence for Breast Cancer.

The Missing Piece in Breast Imaging 

Breast MRI, in contrast to mammography and breast ultrasound procedures, does not currently have an AI support tool for breast MRI cleared by the FDA for clinical use. The gap carries particular weight when it comes to women at elevated risk: 43% of women over the age of 40 have dense breast tissue and make up 71% of breast cancer diagnoses. For women with extremely dense breasts, the limitations of conventional screening are especially significant, with mammography potentially missing up to 50% of cancers.

It was this issue that Dr. Debbie Anaby, the company’s CTO and Head of Sheba’s Breast Cancer Imaging Lab, set out to address after noticing a pattern in her clinical work: some breast cancers were visible retrospectively on earlier MRI scans, long before diagnosis, but the subtle findings were difficult for radiologists to detect at the time.

When building its AI tool, PinkStar drew on the data resources of Sheba’s Meirav Breast Cancer Center, which performs more than 5,000 breast MRIs each year — one of the clinical assets that has made Sheba a hub for innovation in imaging. Early results have shown the technology can classify more than 65% of breast cancers in high-risk women a year before they are formally diagnosed, though the approach remains under development. The Mount Sinai agreement extends that foundation with a new source of real-world clinical data. 

Innovation Beyond Borders

Sheba Medical Center continues to see its homegrown innovations extend beyond Israel’s borders, with the PinkStar-Mount Sinai collaboration marking the latest example of breakthroughs that originated at Sheba advancing patient care globally. This kind of cross-border reach reflects the center’s broader role in shaping medical innovation through international cooperation—a commitment that has helped it earn a place among Newsweek’s World’s Best Hospitals for eight consecutive years.

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