Oxehealth Vital Signs

DEN200019

Oxehealth Limited · granted 2021-03-26 · product code QME · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.1)
“The Oxehealth Vital Signs device is intended for noninvasive spot measurement of pulse rate and estimated breathing rate (chest wall movements) when the subject is still. It is software assessing video footage from a fixed-installation solution for use within single occupancy rooms within hospitals, general care and secured environments with professional healthcare oversight and where a framework exists which mandates periodic checks by a trained professional to ensure subject safety.”
Algorithmsoftware algorithm that reads data collected using off-the-shelf cameras collecting images in the near-infrared spectrum. Pulse rate is determined by monitoring pixel intensity changes for exposed skin. Breathing rate is determined with motion tracking of the patient's chest.
source quote (p.2)
“The device is a software algorithm that reads data collected using off-the-shelf cameras collecting images in the near-infrared spectrum. These images can be used to act as a non-contact monitor of pulse and breathing rates for individuals aged 18 and older in single-subject room environments. Pulse rate is determined by monitoring pixel intensity changes for exposed skin. Breathing rate is determined with motion tracking of the patient's chest. Video is collected through video cameras installed in each room. When run through proprietary software-controlled algorithms, the software will allow a user to make spot checks for pulse and estimated breathing rates (chest wall movements) of the individual in the room.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.3)
“Because the device is network connected, appropriate documentation was provided in accordance with FDA's 2014 guidance titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” to support adequate cybersecurity measures have been taken and will be monitored and updated throughout the device life cycle.”

Validation studies (3)

Bench

sample size not stated

standards: FDA's 2005 guidance titled, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.”, FDA's 2014 guidance titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”

Bench

n=10 other

endpoints: ensuring measurement is taken from a patient; distinguishing historical measurements from current measurements

Retrospective clinical

n=60 patients

endpoints: assess the accuracy of pulse rate and estimated breathing rate (chest wall movements) measurements made using the Oxehealth Vital Signs device, calculated as the root mean square difference (RMSD) across all measurements when compared to a standard contact device

Reported performance (2 observations)

f1as written: “Percentage of measurement attempts resulting in a displayed pulse rate”58CI 95% CI 51% - 65%
source quote (p.4)
“For measurements for which the device could be used within its label (that is, with the participant not moving at the time of measurement, and, in the case of pulse rate measurement, with skin visible), 58% (95% CI 51% - 65%) of measurement attempts resulted in a displayed pulse rate”
f1as written: “Percentage of measurement attempts resulting in a displayed breathing rate”73CI 95% CI 68% - 79%
source quote (p.4)
“and 73% (95% CI 68% - 79%) of measurement attempts resulted in a displayed breathing rate.”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: De Novo decision summary PDF.

Predicate network

Postmarket — what happened after clearance

Not yet tracked — the weekly postmarket refresh hasn't snapshotted this device.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to De Novo AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/DEN200019