Hologic, Inc.

FDA clears the first nucleic acid test.

Hologic introduces the first dual-energy X-ray absorptiometry system for evaluating osteoporosis.

FDA clears the first molecular diagnostic test kit for a sexually transmitted infection.

FDA approves the Rapid fFN® test.

FDA approves the ThinPrep® Pap test, liquid-based cytology for cervical cancer screening.

FDA approves the NovaSure® endometrial ablation treatment for abnormal uterine bleeding (AUB).

FDA approves the Selenia® mammography system–the beginning of a new era in breast cancer screening.

FDA approves the first nucleic acid test for screening donated blood prior to transfusion.

Release of the Tigris® DTS® system for automated screening of sexually transmitted infections (STIs).

FDA approves the Procleix® Ultrio®* triplex blood screening assay for HIV-1, hepatitis B and C.

FDA approves the breakthrough Selenia Dimensions®

FDA approves the breakthrough Selenia Dimensions® digital tomosynthesis system with the Hologic 3D Mammography™ exam.

FDA clears the Panther® system, an automated, integrated molecular platform, for use with the Aptima Combo 2® assay.

FDA clears the use of the bone densitometer for assessing three critical health problems, including osteoporosis.

CE marked virology portfolio, including Aptima® HIV, HCV and HBV assays, along with the Aptima® M. genitalium assay.

FDA clears the new Affim® prone biopsy system.

FDA approves Aptima® HIV-1 Quant assay, Aptima® HCV Quant DX assay, and the Aptima® HSV 1 & 2 assay. The Panther Fusion® respiratory assays were approved on the Panther Fusion system.

The Brevera® breast biopsy system with CorLumina® imaging technology combines tissue acquisition, real-time imaging, verification and advanced tissue handling.

FDA clears Clarity HD high-resolution 3D™ imaging and the SmartCurve™ breast stabilization system, providing superior image quality and a clinically proven solution for a more comfortable mammogram.

The FDA grants clearance to the new Aptima® BV and Aptima® CV/TV assays, which provide an accurate and objective method for diagnosing vaginitis.

FDA grants Emergency Use Authorization (EUA) for the Panther Fusion® SARS-CoV-2 and Aptima® SARS-CoV-2 assays, molecular diagnostic tests detecting the novel coronavirus.