Hologic Inc. won CE Mark approval in the European Union for its ThinPrep integrated imager for cervical cancer.
The Bedford, Mass.-based women’s health products maker said the approval clears the way for it to bring the device to market in the EU’s 27 member countries, plus the three European Free Trade Assn. members and other nations that recognize the mark.
The ThinPrep device integrates imaging technology and slide review into a single device. It works by analyzing a Pap smear slide, scanning each cell or cell cluster and flagging “diagnostically relevant” cells or cell groups, according to a press release.
A cytologist then checks the flagged areas for abnormalities; if none are evident the slide is deemed negative, but if abnormalities are detected it can be forwarded through the lab’s quality control process. As an added bonus, the imager can be used as a conventional microscope.
The Food & Drug Administration has not cleared ThinPrep integrated imager for sale in the U.S., but Hologic’s director of corporate communications Jeff Keene told MassDevice that the company is determining the best approach to gain FDA approval.
Hologic posted $41 million in third-quarter net income on $403 million in sales, a 32 percent drop from the $61 million the company reported on $430 million in sales during the same period last year.