Heart Rate Detection Feature On Apple Watch Gets FDA Permit

Illustration of the AFib feature on Apple Watch (photo: dock. Apple)

JAKARTA The Food and Drug Administration (FDA) has granted permission to users of the Atrium Fibrilation feature (AFib) on Apple Watch. According to the FDA, this feature has met the requirements for Medical Device Development Equipment (MDDT). The FDA says that AFib is the first digital health technology to obtain MDDT certification. By obtaining official permission from the FDA, Apple Watch can now be purchased for health reasons because of the AFib feature in it. "The FDA announces a new tool qualification to assess estimates of atrium fibrillation loads (arithmias, or abnormal heartbeats) in clinical studies through the Medical Device Development Tool (MDDT) program," the FDA said in its announcement. FDA acknowledged the reliability of the Apple-made feature. According to the US state agency, AFib is safe for use in research studies because it produces, "scientifically plausible measurements." AFib is designed as a means of evaluation of safety and heart health. With the AFib feature, the FDA explains that Apple Watch can be used, "to help evaluate AFib load estimation as a secondary effectiveness endpoint in clinical studies."

With the permission to use the AFib feature, Apple Watch now has three official health support features. Two of them, namely the electrocardiogram (EKG) feature and irregular heart rhythm detector, obtained permission in 2018. Although these three features have obtained permission from the FDA, the measurement results must be needed in medical needs. This means that users cannot trust the results 100 percent because the detection results can only be used as an evaluation before treatment.