History of Innovation
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1985
FDA clears the first nucleic acid test.
1985
FDA clears the first nucleic acid test.
1987
Hologic introduces the first dual-energy X-ray absorptiometry system for evaluating osteoporosis.
1987
Hologic introduces the first dual-energy X-ray absorptiometry system for evaluating osteoporosis.
1988
FDA clears the first molecular diagnostic test kit for a sexually transmitted infection.
1988
FDA clears the first molecular diagnostic test kit for a sexually transmitted infection.
1995
FDA approves the Rapid fFN® test.
2002
FDA approves the Selenia® mammography system–the beginning of a new era in breast cancer screening.
2002
FDA approves the Selenia® mammography system–the beginning of a new era in breast cancer screening.
2002
FDA approves the first nucleic acid test for screening donated blood prior to transfusion.
*Procleix and Ultrio are registered trademarks of Grifols, SA.
2002
FDA approves the first nucleic acid test for screening donated blood prior to transfusion.
*Procleix and Ultrio are registered trademarks of Grifols, SA.
2003
Release of the Tigris® DTS® system for automated screening of sexually transmitted infections (STIs).
2003
Release of the Tigris® DTS® system for automated screening of sexually transmitted infections (STIs).
2008
FDA approves the Procleix® Ultrio®* triplex blood screening assay for HIV-1, hepatitis B and C.
*Procleix and Ultrio are registered trademarks of Grifols, SA.
2008
FDA approves the Procleix® Ultrio®* triplex blood screening assay for HIV-1, hepatitis B and C.
*Procleix and Ultrio are registered trademarks of Grifols, SA.
2011
FDA approves the breakthrough Selenia Dimensions® digital tomosynthesis system with the Hologic 3D Mammography™ exam.
2011
FDA approves the breakthrough Selenia Dimensions® digital tomosynthesis system with the Hologic 3D Mammography™ exam.
2012
FDA clears the Panther® system, an automated, integrated molecular platform, for use with the Aptima Combo 2® assay.
2012
FDA clears the Panther® system, an automated, integrated molecular platform, for use with the Aptima Combo 2® assay.
2014
FDA clears the use of the bone densitometer for assessing three critical health problems, including osteoporosis
2014
FDA clears the use of the bone densitometer for assessing three critical health problems, including osteoporosis
2015
CE marked virology portfolio, including Aptima® HIV, HCV and HBV assays, along with the Aptima® M. genitalium assay.
2015
CE marked virology portfolio, including Aptima® HIV, HCV and HBV assays, along with the Aptima® M. genitalium assay.
2017
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.
2017
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.
2017
The Brevera® breast biopsy system with CorLumina® imaging technology combines tissue acquisition, real-time imaging, verification and advanced tissue handling.
2017
The Brevera® breast biopsy system with CorLumina® imaging technology combines tissue acquisition, real-time imaging, verification and advanced tissue handling.
2018
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.
2018
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/VT assays, which provide an accurate and objective method for diagnosing vaginitis.
.
The FDA grants clearance to the new Aptima® BV and Aptima® CV/VT assays, which provide an accurate and objective method for diagnosing vaginitis.
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2020
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.
2020