The Verily Study Watch, developed by Verily — an arm of Google parent company Alphabet — has received FDA 510(k) clearance for an “on-demand ECG feature.” The Verily Study Watch is a prescription-only wearable that can record, store, transfer and display single-channel ECG rhythms.
Verily has been working on a health watch for several years, with the aim to design an inconspicuous biosensing device that could monitor the user’s health either for clinical or for research purposes. Now, the newly developed device has been used by thousands of people as part of clinical research studies in a number of studies including Verily’s Project Baseline, Aurora study and Personalized Parkinson’s Project, according to a statement. The new FDA approval will allow the devices to be used for more research projects.
“This work may ultimately give us insights into the utility of integrating mobile health data into the clinical care environment, and how these data can support the physician-patient relationship… Together, we are working towards a future where we can use devices, like the FDA-cleared Study Watch, to inform real-world, personalized care decisions and help us move to proactive healthcare,” said Michael V. McConnell, M.D., Head of Cardiovascular Health Innovations at Verily.
It’s important to note that FDA ‘clearance’ as a Class II device is very different from FDA ‘approval,’ which is typically reserved for Class III products, or technologies that might have higher risk but also a higher benefit (e.g. implantable pacemakers). The difference, as The Verge’s Angela Chen explained when the Apple Watch received its clearance, is that the FDA isn’t making any judgments on the actual efficacy of the device, only that it’s safe to use.
Chen explains that “For Class II and Class I, the FDA doesn’t give ‘approval,’ it just gives clearance. Class I and Class II products are lower-risk products.” A classic Class I example is something like a tongue depressor – and it’s much easier to get clearance than approval, according to Jon Speer, co-founder of Greenlight Guru, a company that makes quality management software for medical device companies.