Organization (Industry)
Hologic (Germany)
ClinicalTrials.gov lists Hologic (Germany) as lead sponsor of 28 trials.
Search trials, drugs, companies and investigators, and follow each one to the others. Individual plan, $249/seat/mo. Card required.
Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 0 registered with a 2026 start date. The dashed outline is the pace from the 0 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 1.2 trial starts a year over the five years to September, under the 5 a year the method needs.
Logo Hologic, via Wikimedia Commons, Public domain. Shown to identify the organization; it may be a registered trademark.
This page covers Hologic (Germany): 28 lead-sponsored trials and 4 legal-entity registrations.
Disease areas (25)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Breast Neoplasms | 17 |
| Hemorrhage | 5 |
| Leiomyoma | 4 |
| Menorrhagia | 3 |
| Polyps | 3 |
Showing 5 of 25 disease areas.
Trials by start year as sponsor or collaborator (21)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2025 | 1 |
| 2024 | 1 |
| 2023 | 2 |
| 2022 | 1 |
| 2021 | 2 |
| 2020 | 2 |
| 2019 | 1 |
| 2018 | 3 |
| 2017 | 2 |
| 2016 | 3 |
Showing 10 of 21 years.
Recruitment duration, a model prediction: 3 trials still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 60% hit target (n=5) | 2 of 4 on time (n=4) |
Journals published in (12)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Radiology | 4 |
| Obstetrics and gynecology | 2 |
| PloS one | 2 |
| The New England journal of medicine | 2 |
| Academic radiology | 1 |
Showing 5 of 12 journals.
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 684 | 232 | 2025-12-30 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| OAI | 45 |
FDA recalls (48)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D. | Class II | 2026-04-08 |
| 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NS. | Class II | 2026-04-08 |
| Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm cleared under DEN210035. | Class II | 2026-03-23 |
| Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No | Class II | 2026-02-18 |
| Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. | Class II | 2025-12-15 |
Showing 5 of 48 recalls.
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 4 | 2024-05-24 |
Manufacturing and distribution sites (5)
Shown in this order: severity rank then name.
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| HOLOGIC, INC. | Marlborough, US | FDA | |
| Hologic, Inc. | Marlborough, US | FDA | |
| Hologic, Inc. | SAN DIEGO, US | FDA | |
| Hologic, Inc. | LONDONDERRY, US | FDA | |
| HOLOGIC, INC. | Newark, US | FDA |
Latest dated events (831)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-04-08 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2026-04-08 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2026-03-23 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2026-02-18 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-12-30 | Patent granted | Granted US patents (PatentsView / USPTO) |
Showing 5 of 831 events.
Biomarker capability evidence (17)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| EGFL8 | Trial sponsor | Named in trial inclusion criteria |
| NADK | Trial collaborator | Named in trial inclusion criteria |
| PVR | Trial sponsor | Named in trial inclusion criteria |
| RNF5 | Trial sponsor | Named in trial inclusion criteria |
| SHC1 | Trial collaborator | Named in trial inclusion criteria |
Showing 5 of 17 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, active development programs, approved assets, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, climate targets, as filed, workforce and board diversity, as filed, organization relationships, clia clinical laboratory certificates, and biomarkers this organization publishes on.