Verily Study Watch gets FDA clearance for ‘Irregular Pulse Monitor’

Even before Google’s Fitbit acquisition, Alphabet already has a health wearable with the Verily Study Watch. That clinical device has just received FDA clearance to detect irregular heart rhythms.

The most common irregular heartbeat is atrial fibrillation (AFib) wherein the upper and lower chambers of the heart are out of sync. Blood not properly moving through the body can result in clots and strokes. It can manifest as rapid beating, palpitations, and shortness of breath, but not all with AFib encounter symptoms.

Today’s 510(k) clearance from the FDA aims the “Study Watch with Irregular Pulse Monitor” for those 22 years and older that have been diagnosed or are susceptible to the condition. In wearing, the goal is to improve screening, diagnosis, and management.

It comes as cardiovascular research and care is an area that Verily has been focussing on, including through a collaboration with iRhythm on AFib. Still in “early stages,” the two want a clinical solution that takes into account clinician workflows, care pathways and the patient experience.

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 AFib.

AFib detection joins other Verily Study Watch capabilities like heart rate, electrodermal activity, and movement. The device is shaped like a regular timepiece with one-week battery life, e-ink display, and three side buttons for navigation. Last year, the device was also cleared for ECG recordings by the FDA.

Verily continues to note that the “Study Watch will not be directly available to consumers.” Meanwhile, the Apple Watch has had AFib detection for two generations now, and Withings also has the capability.