Organization (Industry)
BIOSENSE WEBSTER, INC.
ClinicalTrials.gov lists BIOSENSE WEBSTER, INC. as lead sponsor of 66 trials. It has 2 approved assets.
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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: 8 registered with a 2026 start date. The hollow diamonds on the dashed line are a forecast of the full-year count, planned starts included: about 9 in 2026 and about 8 in 2027, the average of the 24 months through September, counted as registered and carried forward. The columns, the lighter one included, count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. This method has not been backtested on organizations. In backtests on conditions with as many trial starts a year as this organization (5 to 20), forecasts made part-way through the year were typically off by about 28 percent and ran about 20 percent low against the count later registered; forecasts made before the year began were off by about 39 percent and ran about 37 percent low against the count later registered. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.
Logo Johnson & Johnson Services, Inc., via Wikimedia Commons, Public domain. Shown to identify the organization; it may be a registered trademark.
This page covers BIOSENSE WEBSTER, INC.: 66 lead-sponsored trials and 3 legal-entity registrations. Part of KENVUE INC..
Related companies are recorded in the same corporate group by GLEIF, ROR or a curator but are not grouped here; they are listed below with their own counts and are not included in the figures above.
Disease areas (26)
Shown in this order: most trials first (counted at this company's own legal-entity record, not the consolidated group).
| Disease area | Trials |
|---|---|
| Atrial Fibrillation | 96 |
| Tachycardia | 25 |
| Tachycardia, Ventricular | 24 |
| Atrial Flutter | 6 |
| Ventricular Premature Complexes | 6 |
Showing 5 of 26 disease areas.
Trials by start year as sponsor or collaborator (24)
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 |
|---|---|
| 2026 (partial year) | 8 |
| 2025 | 6 |
| 2024 | 8 |
| 2023 | 6 |
| 2022 | 7 |
| 2021 | 7 |
| 2020 | 8 |
| 2019 | 5 |
| 2018 | 10 |
| 2017 | 6 |
Showing 10 of 24 years.
Prediction, not a registry value: median of 29 months from start to primary completion across 8 trials still running at the 2026-10-09 snapshot; registered median of 22 months across 50 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Approved assets (2)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| Drug Treatment | 2 |
| Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs | 1 |
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 |
|---|---|
| 64% hit target (n=22) | 41% on time (n=22) |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 7 |
FDA recalls (33)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used for TRUPULSE Generator, for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The catheter provides location information when used with the CARTO 3 System. | Class I | 2025-01-05 |
| CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with a three-way stopcock is provided for air or blood aspiration, and fluid infusion. The handle is equipped with a rotating collar to deflect the tip clockwise = 180¿ and counterclockwise = 180¿. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation, and a radiopaque tip marker to allow fluoroscopic visualization. The sheath has electrodes on the outer surface to allow the sheath to interface with compatible CARTO" 3 Systems. | Class II | 2024-02-16 |
| Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile | Class II | 2023-02-21 |
| Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile | Class II | 2023-02-21 |
| CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart. | Class II | 2022-06-29 |
Showing 5 of 33 recalls.
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 5 | 2021-05-17 |
Manufacturing and distribution sites (2)
Shown in this order: severity rank then name.
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| BIOSENSE WEBSTER, INC. | Irvine, US | FDA | |
| BIOSENSE WEBSTER, INC. | Irvine, US | FDA |
CLIA clinical laboratory certificates (1)
| Lab | Certificate | Status |
|---|---|---|
| BIOSENSE WEBSTER, INC | Certificate of waiver | Terminated |
Biomarker capability evidence (142)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| ACSM1 | Trial collaborator | Named in trial inclusion criteria |
| DCC | Trial collaborator | Named in trial inclusion criteria |
| NPPB | Trial collaborator | Named in trial inclusion criteria |
| OAT | Trial sponsor | Named in trial inclusion criteria |
| PCLAF | Trial sponsor | Named in trial inclusion criteria |
Showing 5 of 142 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, active development programs, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, climate targets, as filed, workforce and board diversity, as filed, and organization relationships.
Counted at group level under Johnson & Johnson: journals published in, us granted patents, latest dated events, and biomarkers this organization publishes on.