FDA Clears Verily Study Watch for Irregular Pulse Monitoring

By Samantha McGrail

Verily Life Sciences was recently granted 510(K) clearance from the FDA for its Study Watch used with Irregular Pulse Monitoring, according to an official blog post from the Alphabet subsidiary.

January 30, 2020 - This grant follows a 2019 clearance for Verily’s Study Watch, which is used for non-invasive, continuous monitoring. With the grant, the company will be able to bolster its approach to building robust, clinical-grade tools and solutions intended to support clinicians in delivering the highest level of care, William Marks, MD, MS-HCM, head of clinical science at Verily, stated in the blog post.

“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,” Marks wrote.

Verily voiced that it has continued to focus on cardiovascular research and care due to the vast amount of individuals that are affected by the disease daily. IRhythm’s own research uncovered that an estimated 10 million Americans are at high risk for atrial fibrillation (AFib). This is the most prevalent irregular heartbeat that can lead to additional life threatening problems.

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Working with iRhythm, the two companies will develop solutions for improved screening, diagnosis, and management of patients with AFib. Additionally, they will aim to create a clinical solution that focuses on clinician workflows, care pathways, and patient experience.

“Since announcing the collaboration in September, our product and engineering terms 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,” Marks wrote.

Verily also emphasized that it will independently use the Investigational Study Watch to collect biometric health information including heart rate and inertial movement through clinical research programs. Research aims to further develop devices to better inform care and 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.”

Wearable technology offers the opportunity to increase patient safety and quality of care by retrieving vital information in an efficient way.

Back in 2018, the Michael J. Fox Foundation for Parkinson’s Research partnered with Verily to equip patients with the Verily Study Watch to collect patient data on movement and physiologic and environmental measures.

Verily Study Watch can help in studying the disease because they enable clinicians to collect real-time data from patients continuously.

"Expanding this resource through data science and wearable computing holds potential to deepen understanding of Parkinson's disease and gain meaningful insights that can inform care and therapeutic development decisions,” said Todd Sherer, PhD, foundation CEO.

Verily isn’t the first organization to attempt to tackle AFib through wearables. Back in November 2019, Apple announced that its product the Apple Watch could be used by clinicians to detect AFib.

Nearly 420,000 people participated in the Apple Heart study which launched in 2017 through a partnership between Apple and American Well. Over the eight month span, the Apple Watch detected an irregular heart rate in 2,161 people, or 5.2 percent.

The participants with irregularity scheduled a consult with a specialist on American Well’s telehealth platform and then given an ECG patch. Of these patients, 34 percent were diagnosed with AFib.

“The study’s findings will help patients and clinicians understand how devices like Apple Watch can play a role in identifying atrial fibrillation, a deadly and often undiagnosed disease,” Mintu Turakhia, MD, an associate professor of cardiovascular medicine, said in announcement.

Networking News

FDA Clears Verily Study Watch for Irregular Pulse Monitoring

The FDA recently granted Verily Life Sciences 510(k) clearance for its Study Watch with Irregular Pulse Monitoring to further improve quality of care.

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