Problems with pulse oximeters have been known for decades, but it wasn’t until the pandemic that the real dangers to Black ...
While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...
The FDA warned the nation about the growing vulnerability of the medical device supply chain and its effects on public health, particularly among pediatric patients, in a Jan. 16 news release.
How the FDA and CMS worked together on a new approach to paying for digital mental health treatments
By establishing coding and separate payment for certain digital mental health devices, this group from CMS and the FDA hopes ...
The new director of the FDA’s device center contrasted a European rule with the U.S.’s lack of mandatory reporting ...
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
From returning hits like 'The White Lotus' to a brand new comedy by Tina Fey and Steve Carell, this year's offerings have ...
Leadership in Medtech issue features former Edwards Lifesciences CEO Mike Mussallem and FDA CDRH Director Dr. Michelle Tarver ...
The Center for Devices and Radiological Health (CDRH) is unveiling an Idea Lab as part of the Home as a Health Care Hub initiative to help innovators, providers and patients reimagine the ...
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
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