Tarver warns that US device supply chain vulnerabilities could harm patients
The new director of the FDA’s device center contrasted a European rule with the U.S.’s lack of mandatory reporting ...
FierceBiotech2d
FDA’s device chief calls for more authority to address supply chain shortages impacting pediatric, neonatal patients
While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
Cryptopolitan on MSN2mon
FDA’s new device chief faces growing pressure as AI and tech transform healthcare
Dr. Michelle Tarver, a veteran of the Food and Drug Administration (FDA), has taken charge of the FDA’s device division at a ...
Becker's Hospital Review2d
FDA spotlights risks in medical device supply chain
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.
FDA recommends fixing racial disparities in pulse oximeter readings
The Food and Drug Administration on Monday proposed a long-awaited plan aimed at improving how pulse oximeters work on people ...
FDA authorizes over-the-counter combined COVID-19 and flu test
our ability to detect these pathogens effectively and efficiently can be impactful on our daily lives," Dr. Michelle Tarver, ...
FDA Pushes to Improve Blood Oxygen Monitor Accuracy Across Skin Tones
The FDA's draft recommendations for pulse oximeters aims to include clinical studies involving at least 150 participants with ...
U.S. regulator aims to improve accuracy of blood oxygen devices for range of skin tones
The U.S. Food and Drug Administration proposed new guidance for devices used to monitor blood oxygen levels to improve their ...