Editor's note: This story has been updated with information from Verily's announcement of the clearance.
Verily, the life sciences research subsidiary of Alphabet, has received FDA 510(k) clearance for an augmented version of its prescription Study Watch wearable that includes some form of arrhythmia monitoring.
The Study Watch With Irregular Pulse Monitor is classified by the FDA as a “telephone electrocardiograph transmitter and receiver,” just as the existing Verily Study Watch was exactly one year prior.
According to a blog post from Verily published roughly a week after the decision, the product is indicated for use in professional healthcare facilities among patients aged 22 years and older who have been diagnosed with or are likely to develop atrial fibrillation. It will not be sold for consumer use.
The new irregular pulse monitoring capability would ostensibly be using the existing device’s on-board single-channel ECG, although it is not 100% clear from the notice whether the update involves a hardware update, a new software application or some combination of the two.
The FDA received Verily’s regulatory submission in early September of 2019, and reached its decision last Friday.
WHY IT MATTERS
Since first revealing the wearable device back in 2017, Verily has positioned its device as a clinical research tool rather than a consumer product. After being used in a number of studies — including Verily’s own Project Baseline, the University of North Carolina-led Aurora Study and the Michael J. Fox Foundation’s Personalized Parkinson’s Project — the company was later able to open more doors with a clearance for on-demand ECG.
Pharma headliners including Novartis, Otsuka, Pfizer and Sanofi have already committed to research projects employing Verily’s monitoring device and broader Project Baseline platform. The addition of this irregular pulse monitoring feature would only open more doors to Verily’s existing partners, and could entice others to jump on board as well.
Also worth highlighting is a September partnership announcement between Verily and iRhythm Technologies, a maker of ambulatory cardiac monitoring patches. The companies said at the time that new atrial fibrillation tools would be the primary focus on their collaboration, with iRhythm contributing its artificial intelligence-based arrhythmia diagnosis know-how alongside Verily's data analytics expertise.
Verily again highlighted that partnership following news of its latest approval.
"Since announcing the collaboration in September, our product and engineering teams have begun work on technical integrations and exploring how we can leverage tools like Study Watch with ECG and Irregular Pulse Monitor and iRhythm’s Zio Service to support continuous monitoring, data analytics and cloud-based machine learning to monitor [atrial fibrillation]," Verily wrote in a blog post describing the 510(k) clearance. "We aim to create a clinical solution that takes into account clinician workflows, care pathways and the patient experience. We’re in early stages, and look forward to sharing more as the work progresses."
THE LARGER TREND
Smartwatch-based health tracking has long been at the heart of digital health, and the past couple of years have seen a push toward onboard ECG features among consumer, provider and pharma-focused devices alike.
Apple has certainly been the most public in these efforts, announcing the sensor and a software-based atrial fibrillation detection feature as cornerstones of its Series 4 Watch. Its launch was quickly followed with the Stanford-led Apple Heart Study; data from a collaboration with Eli Lilly and Evidation Health; and most recently three new large-scale research projects targeting sound exposure, menstrual cycles, heart rate and physical activity.
Meanwhile, this year’s CES saw Withings spotlighting its ScanWatch, an ECG and Sp02-enabled wearable for consumers that is still under FDA review. Fitbit — which is set to become a compatriot of Verily thanks to its pending acquisition — is similarly waiting for a regulatory go-ahead on an atrial fibrillation detection feature for its watches, although its platform is already host to third-party apps from Cardiogram and FibriCheck offering similar features through proprietary algorithms.
