The FDA has just given the Apple Watch a historic first approval for a digital health technology device.
According to the US Food and Drug Administration, the Apple Watch – or more specifically its atrial fibrillation (AFib) feature – has received its approval as a qualified device in the Medical Device Development Tools (MDDT) program. This feature helps detect abnormal heart patterns and has already been credited to save the lives of users.
This FDA approval allows the Apple Watch AFib feature to be used as a “tool to evaluate estimates of atrial fibrillation burden (a type of arrhythmia or abnormal heart rhythm) in clinical studies “.
Crushable speed of light
The Apple Watch can now be used as a “non-invasive biomarker test to help evaluate estimates of the burden of atrial fibrillation as a secondary effectiveness endpoint in clinical studies designed to evaluate the safety and the effectiveness of cardiac ablation devices to treat,” according to the FDA.
A digital first
But perhaps even more notable is that the Apple Watch AFib feature becomes the first-ever digital health technology to qualify under the FDA’s MDDT program.
The Apple Watch had already received “clearance” from the FDA to include the atrial fibrillation detection feature in the device in 2022. According to 9to5Macthis was the “lowest hurdle”, with Apple essentially proving that its AFib functionality worked the same as existing devices that affect AFib.
This FDA approval for the MDDT program places the Apple Watch in a unique category, particularly regarding its application in clinical studies.
