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Hologic, Inc. FDA Approvals
0 new drug approvals and 21 device clearances on file. Matched by name to HOLX.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| I-View®510(k)Sep 2, 2026Radiology |
| Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)510(k)Aug 12, 2026Gastroenterology, Urology |
| CoolSeal Generator® (CSL-200-90)510(k)Jun 17, 2026General, Plastic Surgery |
| Panther Fusion GI Expanded Bacterial Assay510(k)Sep 25, 2025Microbiology |
| Genius AI Detection 2.0510(k)Jul 31, 2025Radiology |
| Aptima SARS-CoV-2 Assay510(k)Feb 13, 2025Microbiology |
| Aptima CMV Quant Assay510(k)Jan 17, 2025Microbiology |
| Aptima BV Assay; Aptima CV/TV Assay510(k)Nov 25, 2024Microbiology |
| Panther Fusion SARS-CoV-2/Flu A/B/RSV assay510(k)Nov 15, 2024Microbiology |
| Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)510(k)Jul 25, 2024Obstetrics/Gynecology |
| Aptima HCV Quant Dx Assay510(k)Jul 24, 2024Microbiology |
| Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay510(k)Jul 18, 2024Microbiology |
| Genius Digital Diagnostics System with the Genius Cervical AI algorithm510(k)Jan 31, 2024Pathology |
| Aptima Neisseria gonorrhoeae Assay510(k)Jan 26, 2024Microbiology |
| Aptima® Chlamydia trachomatis Assay510(k)Nov 16, 2023Microbiology |
| Aptima Trichomonas vaginalis Assay510(k)Nov 6, 2023Immunology |
| Genius AI Detection 2.0 with CC-MLO Correlation510(k)May 23, 2023Radiology |
| Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay510(k)May 16, 2023Microbiology |
| Panther Fusion AdV/hMPV/RV Assay510(k)May 5, 2023Microbiology |
| Genius AI Detection 2.0510(k)Oct 6, 2022Radiology |
| Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris510(k)Jun 3, 2022Microbiology |