Marlborough medical device company Hologic has won regulatory approval for a new device using artificial intelligence to detect subtle potential breast cancers.
The U.S. Food and Drug Administration approval, which Hologic announced late Tuesday, makes the company’s technology, called Genius AI Detection, available commercially for the first time. Hologic called the new technology a pivotal milestone in the detection of breast cancer.
Genius AI Detection software was shown in studies to aid in the identification and early detection of breast cancer when used with Hologic’s Genius 3D mammography exam, the company said.
The breast cancer detection approval is the third major regulatory hurdle cleared by the company in the past month. Its Genius Digital Diagnostics System was approved by European regulators to help identify precancerous lesions during cervical cancer screenings, and an HIV test won FDA approval for what Hologic said is the first device in the country that can be used for both diagnosis and viral load monitoring.
