Whiterabbit gets FDA nod for breast density AI software

Women's imaging artificial intelligence (AI) startup Whiterabbit has garnered U.S. Food and Drug Administration (FDA) clearance for its WRDensity breast density analysis software.

WRDensity is designed to provide objective data to help radiologists identify the level of breast density, according to the company, which said it's now emerging from stealth mode. The software received FDA clearance in October.

WRDensity joins two other software offerings in Whitetabbit's portfolio: Act and WRRisk. A software and AI-powered service, Act customizes and automates the process of scheduling annual mammogram appointments. It also sends reminders and provides breast health education to women, the vendor said.

Thanks to Whiterabbit's partnership with imaging services provider RadNet, Act has been implemented in over 400 clinics in the U.S., which has led to significant growth in screening volume, according to the company.

WRRisk provides a patient risk rating in order to develop a digital personalized screening plan aimed at enabling more consistent follow-up recommendations and more accurate diagnosis, Whiterabbit said.

Founded in 2017, the firm also said it has developed a large dataset via a partnership with the Mallinckrodt Institute of Radiology. It's received more than $49 million in funding so far, including $21.1 million in a series A round in October 2019. Investors include WRVI Capital and Aceso Technology Partners.

In other company news, Whiterabbit has appointed Dr. Alexander Sardiña as its new CEO. A radiologist, Sardiña comes to Whiterabbit after a stint as chief medical officer for Solis Mammography. He has also been CEO and chief medical officer of 3D mobile mammography provider Covia Health.