The FDA just gave the Apple Watch a historic first approval for a digital health tech device.
According to the U.S. 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. The feature helps detect abnormal heart patterns and has previously been credited for saving users’ lives.
This FDA approval allows the Apple Watch AFib feature to be used as a « tool to assess atrial fibrillation (a type of arrhythmia, or abnormal heartbeat) burden estimates within clinical studies. »
The Apple Watch can now be used as a non-invasive « biomarker test to help evaluate estimates of AFib burden as a secondary effectiveness endpoint within clinical studies intended to evaluate the safety and 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 previously received FDA « clearance » to include the atrial fibrillation detection feature in the device in 2022. According to 9to5Mac, this was the « lowest hurdle » with Apple basically proving that its AFib feature worked similarly to existing devices that affect AFib.
This FDA approval for the MDDT program places the Apple Watch in a unique category, particularly concerning its application in clinical studies.
