Verily Life Sciences, LLC

Verily Life Sciences, LLC specializes in two main categories of medical devices: self-care monitoring and reporting software, including tools for tracking health metrics like irregular pulse detection via wearable devices (e.g., Study Watch), and ophthalmic fundus cameras (e.g., Verily Numetric Retinal Camera). These devices are designed for consumer use and clinical monitoring, respectively, addressing areas like cardiovascular health and diabetic eye disease.

Verily Life Sciences, LLC is headquartered in the United States, which means its devices fall under the jurisdiction of the FDA. Since the company develops both software-based and hardware devices (e.g., Onduo and Verily Numetric Retinal Camera), these products are regulated through FDA pathways like 510(k) clearances or De Novo authorizations, depending on their classification as Class I or Class II.

Verily Life Sciences, LLC’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The 510(k) database includes pre-market submissions for devices deemed substantially equivalent to existing cleared products, while the UDI system ensures standardized identification for tracking and compliance. This listing reflects the company’s focus on regulated pathways for both software and hardware devices.

Verily Life Sciences, LLC’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk (e.g., some monitoring software or low-risk cameras), while Class II devices require stricter controls due to moderate risk (e.g., retinal imaging tools for diabetic eye disease). The classification determines the regulatory pathway, such as 510(k) clearance or De Novo review, ensuring appropriate oversight for their intended use.

Onduo is a software platform designed for self-care monitoring and reporting, likely integrating with wearable devices like the Study Watch to track health metrics such as irregular pulse detection. The Verily Numetric Retinal Camera, on the other hand, is an ophthalmic fundus camera used for retinal imaging, particularly for monitoring diabetic eye disease. Both exemplify the company’s dual focus on consumer health software and specialized medical imaging tools, each regulated separately under FDA pathways.