Shares for iCA Inc. soared last Wednesday in premarket trade following the FDA’s thumbs up for the sale of PowerLook Density Assessment Version 3.4 in the U.S.

The cancer detection and therapy solution enterprise experienced over 30 percent growth upon receiving FDA clearance for its AI intelligence software, which is compatible with its digital breast tomosynthesis platform on GE and Hologic systems.

“Version 3.4 now supports assessing density using 2D synthetic images from GE and Hologic systems,” Ken Ferry, CEO of iCAD, told HCB News. “With the updated version, the product can be used for GE and Hologic breast tomosynthesis cases where no 2D FFDM images are acquired.”
Between 40-50 percent of women in the U.S. alone have dense breasts, which pose the risk of increasing the aggressiveness of tumors and masking their presence in mammograms. When used to evaluate dense breast tissue, the sensitivity of mammography decreases from an average of 98 percent to approximately 48 percent.

Using PowerLook Density Assessment Version 3.4 reduces the risk of reader variability, allowing radiologists to more easily determine if a woman may benefit from additional screening by delivering automated, rapid and reproducible assessments of breast density.

The solution utilizes a machine learning technique to categorize a patient’s breast density, based on the American College of Radiology’s Breast Imaging Reporting and Data system (BI-RADS).

While efficient, Ferry says that more action must be taken on the state level to educate patients about breast density and the associated risks, as well as laws in every state that mandate notifying women of their breast density following a mammogram.

“Ideally, patients should be educated about their density and the associated risks, but that's not always the case,” he said. “Many U.S. states require healthcare providers to notify women – typically via a letter. However, not every state has laws in place that require women to receive some level of notification about breast density following a mammogram. We recommend providers be proactive in notifying patients with dense breasts immediately following a screening.”

Stock for iCAD shed 14 percent year to date through Tuesday, while its performance on the S&P 500 SPX rose on Wednesday by 6.9 percent.

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