Not there yet: Apple's Heart Study reports two-thirds of its study subjects being falsely alerted for atrial fibrillation

May 16, 2019 | Case Study

Apple's new Series 4 smartwatch includes an FDA-approved ECG sensor that can detect heart issues like atrial fibrillation (AFib). AFib refers to irregular heart rhythms that significantly increase one's risk of stroke and heart failure. Apple has benefited from the FDA's Digital Health Software Precertification Program by being listed as a certified developer. Being in this program, however, requires Apple to commit to monitoring the real-world performance of its product. Apple, known to invest tens of billions in R&D every year, spared no expenses here, partnering with Stanford University and recruiting 419,093 volunteers in the largest-ever atrial fibrillation (AFib) screening study in recorded history.

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