Press

This page contains press coverage and press releases for the
Open Oximetry Project.

NPR

Black Health: Finding Solutions to Health Disparities
February 2023

STAT News

“No one’s quite sure how to fix pulse oximeters. The FDA asked this lab to find answers.”
December 2022

FDA Open Public Hearing

Anesthesiology and Respiratory Therapy Devices Panel of the MDAC
November 1, 2022, via YouTube (Talk 1)
November 1, 2022, via YouTube (Talk 2)

STAT News

“Pulse oximeters and their inaccuracies will get FDA scrutiny today. What took so long?”
November 1, 2022

Reuters

“Analysis: Wanted: an oxygen monitor reliable for all races”
November 2, 2022

Wirecutter

“The Best Pulse Oximeter for Home Use”
October 4, 2022

Newswire

UCSF Launches Initiative to Address Disparities in Pulse Oximetry Performance
October 2022

ACP Hospitalist

“The problem with pulse ox”
June 29, 2022

About Community Data Oximetry FAQ Protocols Publications Press

Healthy Human Performance Tests

To meet ISO standards (80601-2-61) or FDA guideline adherence for clinical use, pulse oximeter performance must be tested in healthy humans in a laboratory setting. Independent device testing for the Open Oximetry Project follows our protocol consistent with ISO and FDA. Only devices labeled as ‘verified’ or ‘disputed’ have been independently tested by the Open Oximetry Project.
All other devices listed show data from manufacturers or published literature and have not been confirmed by the Open Oximetry Team. Scoring criteria will be modified based on evolving data on this topic. See the table below for scoring criteria for this category:

No Data

1 (red)

>4%

2 (red)

<4%

AND/OR Data suggesting Arms for dark skin color of >4%

AND/OR Data suggesting Arms for PI<1 in dark or light skin color of >4%

3 (yellow)

<4%

AND/OR Data suggesting Arms for dark skin color of 3-4%

AND/OR Data suggesting Arms for PI<1 in dark or light skin color of 3-4%

4 (green)

<3%

AND No data for or against performance problems in darker skin colors

AND No data for or against performance problems in low perfusion

5 (green)

<3%

AND Extended testing beyond ISO/FDA recommendations Criteria TBD April 2023

* only independently tested devices by OpenOximetry (Hypoxia Lab and Clinimark) get labeled as ‘verified’