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 ...
New FDA guidance aims to improve accuracy of pulse oximeters for people of color
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
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 ...
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FDA looks to clarify confirmatory trial mandate for accelerated approvals
In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory ...
Colorado can now issue licenses to psychedelic mushroom therapy facilitators
This story first appeared in Colorado Newsline. Coloradans will soon be able to take psychedelic mushrooms in a regulated ...
FDA limits toxic lead in some baby foods
The Food and Drug Administration has set maximum levels for lead in baby foods like jarred fruits and vegetables, yogurts and ...
Health care investors gear up for transformative legal developments
Erin Whaley, Tammy Ward Woffenden and Paul M. Mahoney Jr. of Troutman Pepper Locke LLP discuss key market and legal ...
STAT5h
FDA’s new guidance on AI in drug development centers the risk introduced by the technology
After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
STAT5h
A dark anniversary and the last two weeks in health news
Today's health news includes potential cuts to Medicaid under the Trump administration and the five-year anniversary of Covid ...
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IBD 50's GeneDx Surges On FDA Recommendations For AI Device Development
Shares of IBD 50's GeneDx surged Monday after the Food and Drug Administration issued guidance about using AI to develop medical devices.
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Avenacy Provides Update on 2025 Strategic Priorities Ahead of 43rd Annual J.P. Morgan Healthcare Conference
Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today provided an update on recent business highlights and ...