Royal Philips ($PHG) on Thursday announced it is the first medical device company to win 510(k) clearance from the FDA for an application to measure breast density as part of routine mammograms. Women with dense breasts--i.e., less fatty tissue--may be at much higher risk of breast cancer.
The denser the tissue, the harder it is for radiologists to spot a tumor, especially if the tumor is small. The year 2012 saw the approval of U-Systems' somo•v Automated Breast Ultrasound system, specifically designed to more reliably detect cancer in women with dense breast tissue.
Somo•v was one of FierceMedicalDevices' top 10 device and diagnostic approvals that year. In a matter of months, GE Healthcare ($GE) swooped in and scooped up Sunnyvale, CA-based U-Systems in a buyout. Gamma Medica could be a fast follower. The Salem, NH, startup closed a $16M Series A in July 2013 to develop a competing technology for detecting tumors in dense breasts.
In 2012, Stanford and Yale researchers surveyed 105 women, finding a majority of them would welcome additional screening if notified they have dense breast tissue.
Also in 2012, Sabee Molloi, a professor at the University of California, Irvine School of Medicine, was publishing research on the potential use of spectrometry to measure breast density. In one presentation, he compared standard vs. spectral mammography to the difference between black-and-white and color TV.
Molloi also wrote a white paper for Phillips, in which he discussed the same research. He cited prior research showing women with mammographic breast density over 75% may face up to a sixfold increase in breast cancer risk. Another paper he cited showed for every 1% breast density increases, breast cancer risk rises 2%.
With Philips' 510(k), radiologists can use the Spectral Breast Density Measurement Application on the Dutch company's MicroDose SI mammography system to get a volumetric density measurement over the whole breast, differentiating fat and glandular tissue.
- read Philips' press release
- read Molloi's white paper (PDF)
- read the Stanford/Yale survey research
Special Reports: Top 10 device and diagnostic FDA approvals of 2012