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Hologic

HQ: Marlborough, MA source · hologic.com ↗ · New England

FDA-cleared device company Past trials only

Location: Marlborough, MA · source · Oct 13, 2026

Profile checked Oct 10, 2026

Keywords: Breast Cancer Uterine Fibroids Polyps Mammography Breast Cancer Female Breast Screening Urgent Urinary Incontinence Chronic Hepatitis B Menorrhagia Intra-Amniotic Infection of Foetus Reproductive Sterilization Herpes Simplex Infections Chlamydia Trachomatis Gonorrhea Hepatitis C Pre-term Birth Abnormal Uterine Bleeding Infertility Preterm Delivery Brain Metastases Hologic Selenia Dimensions Digital Breast Tomosynthesis System 3D mammograpgy system selective bladder denervation using RF energy NovaSure Endometrial Ablation MyoSure Tissue Removal System Myomectomy Adiana Transcervical Sterilization System Interlace Medical 1st Generation Hysteroscopic Morcellator Hysteroscopic Morcellator

28Trials (company is sponsor)10FDA records (2 yrs)

Timeline

  1. FDA FDA 510(k) clearance: I-View® — K254090, Sep 2, 2026. Applicant at approval: Hologic, Inc. source ↗
  2. FDA FDA 510(k) clearance: Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) — K262792, Aug 12, 2026. Applicant at approval: Hologic, Inc. source ↗
  3. FDA FDA 510(k) clearance: CoolSeal Generator® (CSL-200-90) — K253634, Jun 17, 2026. Applicant at approval: Hologic, Inc. source ↗
  4. FDA FDA 510(k) clearance: Panther Fusion GI Expanded Bacterial Assay — K251993, Sep 25, 2025. Applicant at approval: Hologic, Inc. source ↗
  5. FDA FDA 510(k) clearance: Panther Fusion GI Bacterial Assay — K251868, Sep 25, 2025. Applicant at approval: Hologic. source ↗
  6. FDA FDA 510(k) clearance: Genius AI Detection 2.0 — K243341, Jul 31, 2025. Applicant at approval: Hologic, Inc. source ↗
  7. FDA FDA 510(k) clearance: Aptima SARS-CoV-2 Assay — K243396, Feb 13, 2025. Applicant at approval: Hologic, Inc. source ↗
  8. FDA FDA 510(k) clearance: Aptima CMV Quant Assay — K243935, Jan 17, 2025. Applicant at approval: Hologic, Inc. source ↗
  9. FDA FDA 510(k) clearance: Aptima BV Assay; Aptima CV/TV Assay — K243345, Nov 25, 2024. Applicant at approval: Hologic, Inc. source ↗
  10. FDA FDA 510(k) clearance: Panther Fusion SARS-CoV-2/Flu A/B/RSV assay — K242465, Nov 15, 2024. Applicant at approval: Hologic, Inc. source ↗
  11. Trial start Not phased (device or behavioral study): Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational Device source ↗
  12. Trial start Not phased (device or behavioral study): Prospective Case Collection Study for New Mammography Technologies source ↗
  13. Trial start Not phased (device or behavioral study): A Prospective, Multi-site Clinical Study to Collect User Feedback Using Affirm® Contrast Biopsy source ↗
  14. Trial start Not phased (device or behavioral study): RF Ablation of the Trigone for the Treatment of UUI source ↗
  15. Trial start Not phased (device or behavioral study): Rapid Amniotic Fluid (AF) Test and a Non-Invasive Vaginal Fluid (VF) Test source ↗
  16. Trial start —: Brevera™ Breast Biopsy System Data Collection Study source ↗
  17. Trial start —: A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System source ↗
  18. Trial start —: Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle source ↗
  19. Trial start —: Clinical Evaluation of the Aptima® Combo 2® Assay Using the Panther® System in Female Urine Samples source ↗
  20. Trial start —: Evaluation of the HSV 1 & 2 Assay in Specimens From Symptomatic Subjects source ↗
  21. Trial start —: Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay source ↗
  22. Trial start —: Collection of Plasma and Serum Samples From Individuals Initiating Sofosbuvir for Chronic Hepatitis C for Testing source ↗
  23. Trial start —: Post Approval NovaSure Essure Labeling Study source ↗
  24. Trial start —: fFN Clinical Evaluation in Asymptomatic Women at High Risk for Preterm Birth source ↗
  25. Trial start —: Dual-energy Contrast-enhanced (2D and 3D Mammography Versus Contrast-enhanced MRI)- A Pilot Study source ↗

Showing 25 of 38 dated events.

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 28

RecordTitlePhaseStatusStartPrimary completion
NCT05199701Prospective Case Collection Study for New Mammography TechnologiesNot phased (device or behavioral study)Active, not recruitingDec 10, 2021Nov 5, 2026 (estimated)
NCT06636539Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational DeviceNot phased (device or behavioral study)Active, not recruitingOct 14, 2024Nov 5, 2026 (estimated)
NCT03611543Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard PaddleNot listedCompletedOct 20, 2016Jun 18, 2018 (actual)
NCT00971087Multicenter Hologic Tomosynthesis StudyNot phased (device or behavioral study)Completed2009-092011-09 (actual)
NCT03300206A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy SystemNot listedCompletedSep 13, 2017Mar 19, 2019 (actual)
NCT03456583Brevera™ Breast Biopsy System Data Collection StudyNot listedCompletedNov 20, 2017Nov 20, 2018 (actual)
NCT00990483A Comparison of the 15 and 30 Acquisition Angle Breast Tomosynthesis Mammography for Breast AbnormalitiesNot phased (device or behavioral study)Completed2009-102010-09 (actual)
NCT04408352RF Ablation of the Trigone for the Treatment of UUINot phased (device or behavioral study)SuspendedApr 27, 20202030-02 (estimated)
NCT04671329A Prospective, Multi-site Clinical Study to Collect User Feedback Using Affirm® Contrast BiopsyNot phased (device or behavioral study)CompletedMar 5, 2021Apr 18, 2022 (actual)
NCT00754598Evaluation of a 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital MammographyNot phased (device or behavioral study)Completed2006-072007-05 (actual)
NCT00759447A Pilot Study - Comparison of Two Hologic 3D Mammography SystemsNot listedCompleted2007-122008-09 (actual)
NCT02167113Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) AssayNot listedCompleted2014-032016-02 (actual)
NCT01934244Post Approval NovaSure Essure Labeling StudyNot listedUnknown status (ClinicalTrials.gov)2013-122018-10 (estimated)
NCT03497234Rapid Amniotic Fluid (AF) Test and a Non-Invasive Vaginal Fluid (VF) TestNot phased (device or behavioral study)WithdrawnMar 28, 2018Dec 31, 2019 (estimated)
NCT01369758MyoSure Hysteroscopic Tissue Removal System Registry StudyNot phased (device or behavioral study)Completed2010-112013-05 (actual)
NCT01152112HOME Study: Hysteroscopic Office Myomectomy EvaluationNot phased (device or behavioral study)Completed2010-062012-01 (actual)
NCT00737061Safety & Efficacy Study of the Adiana System for Women Who Desire Permanent Birth Control (Sterilization)Not phased (device or behavioral study)Terminated2002-112005-12 (actual)
NCT02270099Evaluation of the HSV 1 & 2 Assay in Specimens From Symptomatic SubjectsNot listedCompleted2014-122016-08 (actual)
NCT02795975Clinical Evaluation of the Aptima® Combo 2® Assay Using the Panther® System in Female Urine SamplesNot listedTerminatedJun 30, 2016Mar 1, 2017 (actual)
NCT02068963Collection of Plasma and Serum Samples From Individuals Initiating Sofosbuvir for Chronic Hepatitis C for TestingNot listedCompleted2014-022015-04 (actual)
NCT01955148fFN Clinical Evaluation in Asymptomatic Women at High Risk for Preterm BirthNot listedUnknown status (ClinicalTrials.gov)2013-102016-07 (estimated)
NCT01433640Dual-energy Contrast-enhanced (2D and 3D Mammography Versus Contrast-enhanced MRI)- A Pilot StudyNot listedCompleted2011-072013-11 (actual)
NCT01026805Clinical Evaluation of the Interlace Medical Hysteroscopic MorcellatorNot listedCompleted2009-022009-03 (actual)
NCT01177670Adiana Post-Approval Clinical Study (APACS)Not listedTerminated2010-08Not listed
NCT00586326MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-SituPhase 2Completed2003-082006-01 (actual)
NCT00883324Comparison of Fetal Fibronectin (fFN) Specimen Collection Methodologies: With Speculum Versus Without SpeculumNot listedCompleted2009-03Not listed
NCT00979342Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal SystemNot phased (device or behavioral study)Completed2009-112010-07 (actual)
NCT00589212GliaSite 1-3 Mets StudyPhase 2Completed2003-102007-03 (actual)

FDA records (last 2 years)

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