Just Where Does Apple ’s New ECG Fit into the Market?

The inclusion of two heart monitoring apps with the upcoming Apple Watch 4 is causing quite a stir in the wearable device market. Last week, Cupertino, CA-based Apple revealed it received nods from FDA for its wearable watch to include an ECG app, that can classify whether there are signs of atrial fibrillation (AFib), and another app that analyzes pulse rates for irregular rhythms. Earlier this year, MD+DI reported that Apple was working on an FDA submission. The agency has gone on record and said Apple’s solution isn’t designed to replace "traditional methods of diagnosis or treatment.” The response from the industry regarding the new medical apps vary and there are still many unanswered questions about the technology and the potential impact it could have on the wearable device market. “It is exciting to see FDA working hard to foster innovation this way,” Brian Chapman, a principal with ZS, wrote in a research note. “There of course are some hurdles to be met to move from consumer product to true diagnostic medical device so these will be key going forward.” Chapman added, “there is still some distance between a consumer device with the capability of finding a signal and a medicalized diagnostic solution that guides therapy.” Something New or the same old Thing? Apple’s m...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Cardiovascular Source Type: news