Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change that
Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for ...
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 ...
FDA seeks to boost accuracy of blood-oxygen monitors across skin tones
The U.S. health regulator on Monday proposed new guidelines for widely-used blood oxygen monitoring devices to improve their ...
FDA Proposes Changes as Pulse Oximeters May Misread Oxygen Levels in People of Color
Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their ...
FDA seeks to boost blood oxygen monitor accuracy across skin tones
The U.S. health regulator on Monday proposed a new guidance for widely used blood oxygen monitoring devices to improve their ...
FDA seeks to boost blood oxygen device accuracy across skin tones
The U.S. Food and Drug Administration on Monday proposed a new guidance for devices used to monitor blood oxygen levels to improve their accuracy and performance across a range of skin tones. The upda ...
MedPage Today10d
Diversity Reporting Improved in Pulse Oximetry Testing After FDA Guidance
These errors combine to produce failures in detecting life-threatening low blood oxygen levels among individuals ... Ferryman and her team researched the FDA's database to find unique device ...
Reuters24d
US FDA declines to approve injection form of J&J's lung cancer drug
Dec 16 (Reuters) - The U.S. Food and Drug Administration has declined to approve an injectable version of Johnson & Johnson's (JNJ.N), opens new tab drug Rybrevant for a type of lung cancer, the ...
Washington Examiner18d
FDA approves anti-obesity drug as first sleep apnea medication
OSA occurs when a patient’s airway is blocked while sleeping, preventing the person from breathing and causing a drop in blood-oxygen levels ... division of the FDA’s drug evaluation center ...
Winston-Salem Journal18d
Philip Morris USA sues FDA over new cigarette warning labels
a child with an oxygen mask and warnings of erectile dysfunction. The current images are toned down considerably from the FDA’s first attempt in 2012, which featured images of smoke coming out ...
Medscape29d
In the Case of Potential Pediatric OSA, At-Home Sleep Tests or an Overnight Lab Trip?
HSATs measure respiration, air flow, oxygen levels, and body movements ... drugs by the US Food and Drug Administration (FDA). Designated as class II devices, the agency reviews data to determine ...
EMS119d
6 steps to prevent an oxygen tank explosion/regulator fire
The FDA video highlighted several EMS providers that had been injured in an oxygen tank explosion/fire and cited at least one death. Considering how many tens of thousands of times oxygen tanks ...