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 ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 ...
Look for this logo on smart home products if security is important to you
Manufacturers can earn the mark by having their products tested by the National Institute of Standards and Technology (NIST), ...
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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 ...
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FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 ...
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FDA Issues Draft Guidance on AI-Enabled Medical Devices
The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices.
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FDA Issues Draft Guidance for Improving Skin Tone Disparities of Pulse Oximeters
The agency is proposing that device manufacturers improve their testing to including larger, more diverse sample sizes.