FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 ...
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Scientific Information on Unapproved Uses of Medical Products: FDA’s Final Guidance on Firm Communication to Health Care Providers
The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry ...
US to Launch Cyber Trust Mark to Label Secure Smart Devices
The Cyber Trust Mark will help consumers make more informed decisions about the cybersecurity of products, according to the ...
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FDA Issues Draft Guidance on AI-Enabled Medical Devices
The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices.
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Few medical devices are designed for children. An FDA-Children’s National collaboration aims to change that.
Kolaleh Eskandanian, chief innovation officer at Children’s National Hospital, said the partnership is meant to address the ...
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FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
Pulse oximeters are small finger-clamp devices that estimate how much ... for the clinical testing and labeling of these electronic medical devices. One of the recommendations is to include ...