8 results

• FDA Proposes New Guidance To Address Pulse Oximeter Inaccuracies Due to Skin Tone

  January 9, 2025

  Martha Garcia

  Federal regulators have put forward new draft guidelines for ensuring the accuracy of pulse oximeters, which can perform poorly on darker skin tones, resulting in patients not receiving life-saving care.

• FDA Introduces New Program To Promote Greater Diversity in Cancer Clinical Trials

  May 23, 2024

  Martha Garcia

  The FDA has announce a new program which seeks to expand diversity in clinical trials for cancer drugs, in hopes of representing traditionally underserved patients and communities, and expand access to emerging treatment and medical devices.

• FDA Report Details How Agency Made Medical Devices Safer in 2023

  April 22, 2024

  Martha Garcia

  An FDA report highlights improvements in medical device recalls, post-marketing surveillance and manufacturing quality in 2023.

• FDA to Hold Public Hearing on Addressing Pulse Oximeter Inaccuracies

  November 27, 2023

  Martha Garcia

  The FDA is investigating the safety and accuracy of pulse oximeters for patients of different races and ethnicities with darker skin pigmentation.

• Advisory Committee Urges FDA to Raise Standards for Pulse Oximeters

  November 3, 2022

  Martha Garcia

  The panel recommends the FDA shore up pulse oximeter accuracy requirements and warn doctors of the potential risks when using them on darker skinned patients.

• FDA to Hold Advisory Committee Hearing on Problems with Pulse Oximeters

  June 30, 2022

  Irvin Jackson

  The FDA will convene an advisory committee hearing later this year to discuss inaccuracies in pulse oximeters when used on patients with darker skin.

• Poorly Designed Pulse Oximeters Endangered Black and Latino Patients During Pandemic, Study Finds

  June 8, 2022

  Martha Garcia

  Pulse oximeters do not work as well on people of color, resulting in some black and hispanic patients receiving delayed treatment for COVID-19, according to the findings of a new study.

• Pulse Oximeters Less Accurate When Used On Dark-Skinned People of Color, FDA Warns

  February 22, 2021

  Irvin Jackson

  The FDA warns that pulse oximeters may be more inaccurate when used on people of darker skin.