Apple Watch feature becomes first FDA-approved digital health technology

The FDA just approved the Apple Watch as a digital health technology device for the first time in history.

According to the U.S. Food and Drug Administration, the Apple Watch—or more specifically its atrial fibrillation (AFib) feature—has received It is approved as a qualifying device under the Medical Device Development Tool (MDDT) program.This feature helps detect abnormal heart patterns and has previously been credit To save users’ lives.

The FDA’s approval allows the Apple Watch AFib feature to be used as “a tool to estimate the burden of atrial fibrillation, a heart rhythm disorder or abnormal heartbeat, in clinical studies.”

The FDA says the Apple Watch can now be used as a non-invasive “biomarker test to help assess estimates of AFib burden as a secondary effectiveness endpoint in clinical studies designed to evaluate the safety and efficacy of cardiac ablation device treatments.” .

Numbers first

But perhaps more notably, the Apple Watch AFib feature became the first digital health technology ever to qualify for the FDA’s MDDT program.

Apple Watch has previously received “clearance” from the FDA to include atrial fibrillation detection in the device in 2022. 9 to 5which is Apple’s “lowest hurdle,” essentially proving that its AFib feature works similarly to existing devices that affect AFib.

The FDA’s approval of the MDDT program places the Apple Watch in a unique category, particularly regarding its use in clinical studies.