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Organization (Industry)

MASIMO CORPORATION

ClinicalTrials.gov lists MASIMO CORPORATION as lead sponsor of 105 trials. It has 2 active development programs.

US Industry Manufacturer
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19 0 2008 2027

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: 1 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 2 in 2026 and about 2 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 Masimo Corporation, via Wikimedia Commons, Public domain. Shown to identify the organization; it may be a registered trademark.

This page covers MASIMO CORPORATION: 105 lead-sponsored trials and 2 legal-entity registrations.

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Disease areas (50)

Shown in this order: most trials first.

Disease areas
Disease area Trials
Anemia 9
Pain 5
Fever 3
Heart Arrest 3
Agnosia 2

Trials by start year as sponsor or collaborator (19)

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
Trials by start year as sponsor or collaborator
Year Trials started
2026 (partial year) 1
2025 4
2024 4
2023 10
2022 10
2021 4
2020 6
2019 13
2018 19
2017 8

Recruitment duration, a model prediction: 1 trial still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

Active development programs (2)

Shown in this order: max phase, then active trials.

Active development programs
Drug Disease area Max phase Trials
Sham device Pain Not reported 1
Sham device Postoperative Pain Not reported 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.

Sponsor delivery record
Enrollment Timeline
54% hit target (n=13) 77% on time (n=13)

Journals published in (87)

Shown in this order: most published in first.

Journals published in
Journal Publications
Journal of cardiothoracic and vascular anesthesia 15
Anesthesia and analgesia 13
Anesthesiology 13
British journal of anaesthesia 13
Critical care (London, England) 7

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 granted patents
US patents granted Granted in the last 5 years Most recent grant
1,032 348 2025-12-30

Financing and grant events (1)

Financing and grant events
Date Round type Amount (USD) Source
2020-08-31 NIH grant 509,562 Reporter

FDA inspection record (1)

FDA inspection record
Latest classification Inspections
NAI 8

FDA recalls (13)

Shown in this order: most recent first.

FDA recalls
Product Classification Initiated
Radius VSM ECG pre-connected Set, REF: 4842, 4695 Class II 2026-02-20
Radius VSM Disposable NIBP Cuff, REF: 4825, 4826 Class II 2026-02-20
Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only, Class II 2024-02-15
Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only, Class II 2024-02-15
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only, Class II 2024-02-15

FDA import refusals (1)

FDA import refusals
Refused import lines Latest refusal
2 2020-10-06

Manufacturing and distribution sites (4)

Shown in this order: severity rank then name.

Manufacturing and distribution sites
Facility Location Regulators Member organization
MASIMO CORPORATION Irvine, US FDA
MASIMO CORPORATION Irvine, US FDA
MASIMO CORPORATION Irvine, US FDA
Masimo Corporation Irvine, US FDA

Organization relationships (2)

Shown in this order: most evidence first.

Organization relationships
Related organization Relationship Evidence
Nyree Penn Co sponsors trial with 1
PROSOMNIA Sleep Health & Wellness Co sponsors trial with 1

Latest dated events (1,188)

Shown in this order: newest first.

Latest dated events
Date Event Source
2026-08-17 Trial started Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI))
2026-02-20 FDA recall FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment)
2026-02-20 FDA recall FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment)
2025-12-30 Patent granted Granted US patents (PatentsView / USPTO)
2025-12-17 Trial started Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI))

Biomarker capability evidence (27)

Shown in this order: tier desc, then gene symbol.

Biomarker capability evidence
Gene Role Evidence
ERAS Trial collaborator Named in trial inclusion criteria
TEF Trial collaborator Named in trial inclusion criteria
CARD16 Trial sponsor Mentioned in trial text
DBI Trial sponsor Mentioned in trial text
DUT Trial sponsor Mentioned in trial text

Not on this page

Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, approved assets, sec-reported annual financials, fda warning letters, fda untitled letters, climate targets, as filed, workforce and board diversity, as filed, clia clinical laboratory certificates, and biomarkers this organization publishes on.