Whiterabbit emerges from stealth with FDA clearance for AI breast cancer screening tool

The company has developed a line of products targeting the mammography space to enable early and accurate breast cancer detection.
By Mallory Hackett
01:10 pm

Photo: Radovanovic96/Getty Images

A new startup called Whiterabbit has emerged from stealth to announce its new CEO and the FDA clearance of its artificial intelligence-enabled breast cancer screening product.

The company has developed a line of products targeting the mammography space to enable early and accurate breast cancer detection, with the goal of eradicating late-stage breast cancers in the U.S. by 2025.

The WRDensity software received FDA 510(k) clearance last October. It uses AI to provide radiologists with data on the level of breast density, a risk factor of breast cancer.

Whiterabbit also has a tool that reminds patients to schedule breast cancer screening appointments, called ACT, and one that assigns patients a risk score to help providers devise a screening plan for more consistent follow-up recommendations, called WRRisk.

Additionally, the company has named Dr. Alexander Sardiña as its new CEO. He brings two decades of experience to the role, including as the CMO for Solis Mammography and as the CEO and CMO of Covia Health, a Houston-based 3D mobile mammography provider.

As CEO at Whiterabbit, Sardiña will focus on accelerating the company's growth in new markets and expanding its product offerings.

"Increasing the rate of compliance for annual screenings is one of the most important levers for catching cancer early and reducing the rate of late-stage diagnosis,” Sardiña said in a statement.

“I have spent my career improving the practice of early breast cancer detection. I'm excited to continue this work as CEO of Whiterabbit, a pioneer in the application of AI tech for cancer screening."


The U.S. female breast cancer rate is 125 cases for every 100,000 women, according to the Centers for Disease Control and Prevention. This equated to 250,520 new cases of breast cancer among women in 2017, the latest year for which incidence data are available.

Breast cancer has the highest rate of new cases among women of any other type of cancer and is the second deadliest, falling behind only lung cancer.

Screening for breast cancer can help catch it early, when it’s easier to treat, according to the CDC. The American Cancer Society recommends that women should start getting annual mammograms when they turn 45. Once they reach 55, they can start getting screened every two years and should continue, as long as they are in good health.


Studies show that using AI to assist radiologists during mammograms can be a helpful tool for detecting breast cancer. In fact, one that used Kheiron Medical Technologies’ Mia tool found that the AI software could successfully replace one human radiologist when conducting double reading screenings.

Another used an AI algorithm from Google and found that it was more accurate in identifying breast cancer from mammograms than doctors. The system was able to reduce the number of false positives and false negatives in breast cancer detection.

Last summer, Zebra Medical Vision got the green light from the FDA for its HealthMammo product, an artificial intelligence tool that helps radiologists identify suspicious mammograms.

Another company with AI breast cancer screening products is Volpara Health, which recently acquired fellow breast cancer prevention company CRA Health.



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