By: William Marks, MD, MS-HCM, Head of Clinical Science
One year ago, we received our first 510(k) clearance for ECG for Verily Study Watch -- a wrist-worn, sensor-based device for non-invasive, continuous monitoring. Today, we’re thrilled to share that we’ve received a new 510(k) clearance for Study Watch with Irregular Pulse Monitor. This validates our approach at Verily to building robust, clinical grade tools and solutions that can support clinicians in delivering the highest level of care and improve self-management for patients.
We’ve worked carefully to meet the FDA’s stringent requirements for medical devices."
We've worked carefully to meet the FDA’s stringent requirements for medical devices, and with this new indication, will explore opportunities to leverage Study Watch as a measure of irregular pulse in clinical settings across our cardiovascular programs, including our collaboration with iRhythm. Cardiovascular research and care has long been an area of focus for Verily, as millions of patients are impacted by cardiovascular conditions in the US on a daily basis. iRhythm’s own research estimates that 10 million Americans are at high risk for atrial fibrillation (AFib) -- the most prevalent irregular heartbeat that can lead to blood clots and stroke. Our objective is clear: work together to develop best-in-class solutions for improved screening, diagnosis and management of patients with AFib.
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. 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.
In parallel to the work with iRhythm, we’re continuing to use the Investigational Study Watch to collect biometric health information, like heart rate and inertial movement, through our clinical research programs, including Project Baseline. Research will continue to be an important part of developing the right features for devices to inform better care, and ultimately prevent disease. Through research, we have been able to hone Study Watch to better capture rich signals from the human body and generate evidence to support various disease management, treatments and interventions. We’re excited to continue leveraging our tools and technology, like Study Watch, across the research and care continuum of our programs as we move forward in 2020.
Note: The Study Watch with Irregular Pulse Monitor is indicated for use by adult patients (22 years and older) who have been diagnosed with, or are susceptible to developing, atrial fibrillation enabling them to monitor and record their heart rhythms. Study Watch is also intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms. The Irregular Pulse Monitor is indicated for use in professional healthcare facility environments, while worn as a wrist watch. Study Watch will not be directly available to consumers.