Verily (part of Google Family) Receives FDA 510k Approval for Study Watch with Irregular Pulse Monitor

Jan 25, 2020 | Alphabet, Decentralized Clinical Trials, Google, Irregular Pulse Monitor, Study Watch, Verily

Verily (part of Google Family) Receives FDA 510k Approval for Study Watch with Irregular Pulse Monitor

Google’s investments in life sciences become more interesting by the year. Verily, the life science venture holding under Google’s parent Alphabet (NSDQ: GOOGLE), one year ago received their first 510(k) clearance for ECG for the Verily Study Watch—as described in the blog by William Marks, Head of Clinical Science; a wrist-worn, sensor-based device for non-invasive, continuous monitoring. Just days ago, Mr. Marks informed the markets and public that Verily received a new 510(k) clearance for Study Watch with Irregular Post Monitor. The Verily life science operation is now gaining speed in the pursuit of developing FDA-compliant clinical-grade tools and solutions that can support clinicians in the delivery of high-level care while offering the market products that can improve self-management for patients.

Keys to Success

First and foremost, verily (again, a sister organization to Google as both held by Alphabet) has made serious investments in GxP/FDA compliance infrastructure systems and processes. Many a Silicon Valley venture has sought to tap into the enormous potential of life sciences and clinical research. Still, the tech companies often develop a profound aversion to the stringent regulatory regime that governs life sciences—from biotech and pharma to medical device and diagnostic companies. Second, they embrace a culture of openness, clinical rigor, and scientific transparency—important in scientific-driven endeavors—the failure to acknowledge and embrace such principles, practices, and attributes led to the demise of promising companies such as Theranos. Third, they have hired lots of great talent with an emphasis on therapeutic area. This helps them develop the deep domain expertise required to design software and devices that will help those clinicians’ medical professionals in the field. Fourth, they are thinking holistically in terms of platform and collaborative ecosystem—hence not trying to do everything, but building a foundation that can support a range of relevant complementary partnerships. For example, their iRhythm deal—leveraging the great and relevant work in cardiovascular by others. Fifth, they are intelligentlydata driven, ultimately driving toward a future where all various applications and devices are intelligently integrated and connected—creating seamless digital health solutions that address tangible therapeutic challenges.

The Verily team has mobilized their product and engineering units to design and develop technical integrations and interfaces to capitalize on even more powerful ways to leverage their tools; such as Study Watch with ECG and Irregular Pulse Monitor, and services such as iRhythm’s Zio Service to support continuous monitoring, data analytics and cloud-based machine learning to monitor for conditions such as AFib. Partner iRhythm estimate that 10 million Americans are at high risk for atrial fibrillation (AFib).

Moreover, they continue to crank on other critical initiatives such as the Investigational Study Watch for biometric and health information collection (e.g., heart rate, inertial movement, etc.) via programs including Project Baseline. The R&D culture is palpable as an ongoing quest to learn more about what important features are needed for superior devices that inform better care with an audacious and grand goal of ultimately preventing disease.

Importantly, Verily thinks holistically according to Mr. Marks, and contemplates the bigger picture issues facing medical professionals from clinician workflows and care pathways to the incredibly important patient experience—as in both standard care and clinical trials, a patient-centric world is now becoming the new desired goal. For clinical trials, Verily is a key contributor in the march toward the decentralized clinical trial—where technologies such as telemedicine, intelligent apps and devices, cloud technology and AI, and disruptive new care pathways will be leveraged to design patient-centric, decentralized clinical trials that make it easier for the patient to start and finish the study; not to mention contribute far more meaningful and rich data.

Source: Verily


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