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 ...

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 The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the ...

Amid a national reckoning with racism spurred by the COVID-19 death rate among Black Americans, the U.S. Food and Drug Administration's standards for pulse oximeters – those all-too-common devices ...

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 ...