Wareable

Apple Watch AFib feature receives new FDA approval – can now be used in clinical studies

The Apple Watch’s atrial fibrillation (AFib) feature has become the first piece of ‘digital health technology’ to receive MMDT approval from the FDA, ensuring the smartwatch can now be used in ...
9to5Mac

Apple Watch AFib feature gets new FDA seal of approval

When the FDA first cleared Apple to include atrial fibrillation detection by the Apple Watch, that was the lowest hurdle. Specifically, the 510(k) clearance granted to Apple effectively said that the ...
Healio

Accurate pulse oximetry ‘challenging’ in critically ill patients; skin pigmentation a factor

Please provide your email address to receive an email when new articles are posted on . Real-world study looked at relationship between skin pigmentation and pulse oximeter bias in critically ill ...
Healio

FDA releases draft guidance on pulse oximeter study recommendations

Please provide your email address to receive an email when new articles are posted on . The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the ...
CNN

FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 the US Food and Drug Administration is proposing guidance to help make these ...