by 👨💻 Adam Yardley
The ECG feature of Apple Watch 4 was given FDA clearance - but not approval. Now cardiologists warn the new feature may do more harm than good.
The Apple launch event this past week not only allowed us to take a look at the latest in the company’s line of iPhone models for the first time, but also to take a glimpse at their latest iteration of Apple Watch. The Watch is now in its fourth incarnation, and this time around, it’s arrived fitted with an ECG sensor and notifications that can alert users to potential atrial fibrillation. Such tech has apparently been adjudicated over and authorised by the FDA (Food and Drug Administration), but it’s hardly the first tech of its type. Further to this, some are concerned that it may have the opposite effect it intends to offer – in that false positives may come into play.
Professor Adam Cifu, having published a recent paper on an ECG app called AliveCor, isn’t so sure that any device of this nature, in their current forms, could offer the solace and guidance people are in need of. “I’m generally all for patients having access to more information about their health,” advises Prof Cifu, speaking about AliveCor and other similar apps and devices. “I’d have a hard time saying functionalities like this should be suppressed. On the other hand, I’m very concerned because this will certainly cause false positives. We’ll be finding people getting warnings about arrhythmias they don’t have, that will cause anxiety in people.”
▶ Your Cardiologist Won't Like This New Apple Watch Feature
Apple asserted during their live launch of the new Watch that it had received a DeNovo classification from the FDA. This, in layman’s terms, means that it is classification yet to be fully approved. For full approval, extensive testing will be required. As such, the FDA passed the classification for Watch 4 on the grounds that it poses only a ‘moderate risk’ of harm to health. This may well mean that, on paper, Apple has taken the necessary steps to ensure that their device is legal for use – but does it quell any concerns over the emotional and psychological effects it could stimulate?
It is perhaps early days to be deeply concerned about Apple Watch and its effects on users – there is hope that further research and development may fine-tune the model to accurately monitor health in releases and patches to come. For now, it remains a curious piece of tech which, as always, we should wear and use with a pinch of salt.