A recent FierceBiotech article discussed an FDA win for Apple on a medical feature for the Apple Watch. The agency has already cleared Apple’s built-in ECG and irregular rhythms notification that tells the wearer when it detects potential signs of atrial fibrillation. The latest feature, which will be included in the watchOS 9 software release, is the AFib History feature. It estimates how frequently the wearer shows signs of irregular and often extremely rapid heartbeat.
The software gained the FDA’s 5109(k) clearance at the beginning of June, which means it can be used by people over the age of 22 who have been diagnosed with afib. When activated, the watch will send users a weekly summary of their afib frequency and allow them to examine other factors in Apple’s Health app. This includes sleep data, alcohol consumption, and activity–all of which could impact their afib.
