iCAD Inc. has secured a PMA approval from the FDA for the computer-aided detection product for digital breast 3-D tomosynthesis that is based on deep learning. The product is already available via Chicago-based partner GE Healthcare; the Nashua, N.H., start up is working now to make it available to other major tomosynthesis providers.

Known as Powerlook Tomo Detection, it received a CE mark and Health Canada approval last year. In Europe, it's already in use at multiple high-volume breast imaging centers.

APPLYING DEEP LEARNING

"The way the product works is that we have developed a deep learning algorithm that scans each of the digital breast tomosynthesis planes. Our algorithm looks at every one of those areas and takes that information, which gets presented to a radiologist who is reading the study. It takes those areas and blends them into a synthetic 2-D image," iCAD Vice President of Marketing Rodney Hawkins told Medical Device Daily.

"It is the first product of ours to incorporate deep learning technology, a subset of machine learning," he noted.

The approach is effective in reducing the reading time necessary for radiologists – without sacrifices when it comes to sensitivity, specificity or recall rate, according to the pivotal U.S. trial data. The study was of 240 tomosynthesis cases read by 20 radiologists. It found that reading time was reduced by up to 37 percent with Powerlook. A European study of six radiologists with 80 cases had similar results.

Deep learning enables the development of sophisticated algorithms developed by the computer itself as it processes more and more images. The Powerlook was initially developed with 500 cancer cases and many more normal breast images, Hawkins said, that made a total of thousands of images. That enabled the system to achieve a detection rate of 92.3 percent.

"This innovative workflow solution detects suspicious areas on the tomosynthesis planes and that information is used to deliver an enhanced image that focuses the radiologist on the specific areas that need further investigation," said Justin Boatsman, medical director and diagnostic radiologist at Intrinsic Imaging LLC, who took part in the U.S. clinical trial. "This not only helps reduce the reading time and improve the reading experience for radiologists, but it can also provide radiologists with an added level of confidence," he added.

NEED FOR 3-D

A study last year in the Journal of Clinical Oncology found that adding 3-D mammography or ultrasound to regular screening mammograms can detect more cancers in dense breasts, although ultrasound has a slightly better detection rate.

Roughly 43 percent of women who are 40 to 74 are classified as having dense breasts; these patients have both a lower rate of detection and a six times higher risk of developing cancer.

"The algorithm itself was fully developed within iCAD, we did partner with GE to blend detected areas into the synthetic ones to make sure that blending was accurate and looked natural," Hawkins said.

The GE partnership was solely around this product. The imaging giant will market the newly approved product as part of its own tomosynthesis offerings, including their own branded version of it. iCAD will also be marketing directly to GE customers, and eventually to those from other tomosynthesis makers.

"We're working to expand the current product to other ventures, with our immediate focus to cover other tomosynthesis providers in the U.S. We are also exploring how we can leverage the core technology," Hawkins said.

MICROCAP TERRITORY

iCAD went public in 1984 and has long lingered among the ranks of the sub-$200 million valuation companies. The FDA approval gave its valuation a bit of a boost in early trading, adding 10 percent to bring to roughly $77 million.

It had revenues of $6.9 million in the fourth quarter, a gain of 15 percent from the same quarter one year prior. iCAD reported $26.3 million in revenue last year, with a GAAP net loss of $10.1 million.

The company markets computer aided detection for breast, prostate and colorectal cancer, as well as a treatment system known as iCAD's Xoft Axxent electronic brachytherapy system a noninvasive technology that delivers high dose rate, low-energy radiation to target cancerous tissue in non-melanoma skin cancer, early-stage breast cancer and gynecological cancers.

Earlier this year, it closed a deal to sell its magnetic resonance software products Versavue and DynaCAD for $3.2 million to Invivo Corp., which is part of Royal Philips NV. iCAD and Invivo had partnered in 2013 to develop MRI analysis products.

iCAD is optimistic that its newly FDA approved product will help it gain revenue traction, making it more appealing to Wall Street.

"As the use of 3-D mammography continues to grow in the U.S. and abroad, iCAD remains committed to delivering innovative solutions that help radiologists be more efficient and confident when reading tomosynthesis exams," said iCAD CEO Ken Ferry.

He added, "FDA approval of Powerlook Tomo Detection is a significant milestone for the company, and we are positioned to rapidly advance our commercial plan for this innovative technology in the U.S. with the potential to greatly improve clinical workflow and patient care in the years ahead."