When the FDA first cleared Apple to include atrial fibrillation detection by the Apple Watch, that was the lowest hurdle. Specifically, the 510(k) clearance granted to Apple effectively said that the ...
For the first time, the U.S. Food and Drug Administration (FDA) qualified a digital technology — Apple Watch’s AFib History feature — for a special research program. AFib, or atrial fibrillation, is a ...
Apple has made clear that it wants to play a role in the health care market, and now, it's one step closer to looking and feeling like a true health device maker. The US Food and Drug Administration ...
The Apple Watch has grown in versatility since it was first introduced by the Cupertino-based company. It has proved to be a lifesaver in several instances due to its impressive portfolio of features.
An NIH-funded clinical trial is exploring the potential role of wearables in managing atrial fibrillation (AFib), possibly helping reduce patient reliance on lifelong blood thinners. This seven-year ...
Apple's atrial fibrillation (AFib) history feature on Apple Watch has been qualified by the FDA under its Medical Device Development Tools (MDDT) program, the first digital health technology feature ...
Apple Watch has accomplished a noteworthy milestone in digital health with its atrial fibrillation (AFib) history feature now qualified by the FDA under its Medical Device Development Tools (MDDT) ...
A hospital in Pittsburgh has become the latest medical center to join a ground-breaking Apple Watch trial in the US that's helping patients with atrial fibrillation ditch blood-thinning medication.
(NEW YORK) — Last year, Ed Dentel’s Apple Watch informed him that he had an irregular heartbeat. It was right, and potentially saved his life Now scientists are revealing the research behind the ...
Researchers assessed the sensitivity and specificity of each device's automatic AFib detection algorithms using single-lead electrocardiograms (SL-ECG) data, which was subsequently interpreted by ...