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Wednesday, January 23, 2019

FDA Approves Verily Health EKG Watch

 


FDA clears Verily’s prescription-only ECG smartwatch

Verily, the Alphabet research division formerly known as Google Life Sciences, has received a 510(k) clearance from the FDA for its own clinical study smartwatch, complete with an on-demand ECG. But as a prescription-only device, it’s far from a competitor to Apple’s publicly availablesmartwatch.
Verily’s Study Watch was first launched as an investigational device in April 2017 to help capture health information from participants in studies such as Project Baseline—a longitudinal venture by Google, Stanford Medicine and Duke University that aims to track 10,000 volunteers for four years using a variety of metrics.
The FDA cleared a new version of the watch as a class II device for adults, including those with known or suspected heart conditions, for use as a single-lead ECG.

“One area of focus for Study Watch has been cardiovascular health, as heart disease remains the No. 1 killer of men and women in the United States,” Verily’s cardiovascular health innovations head, Michael McConnell, wrote in a company blog post.
“This work may ultimately give us insights into the utility of integrating mobile health data into the clinical care environment, and how these data can support the physician-patient relationship,” McConnell said. Verily plans use both the investigational and the FDA-cleared versions in studies going forward.
Verily recently announced a $1 billion investment round to catapult new global partnerships, business development and potential acquisitions.

On another note:


The glucose-sensing lens was one of Verily’s first projects, launched in January 2014. Since then, it’s evolved into an electronics platform mounted on a soft contact lens, capable of transmitting data using integrated circuits, sensors, batteries and wireless communication hardware, the company said.


Our take-away for this device is that wearing a contact lens requires signifcant training, and for the inexperienced could lead to corneal infections.  Diabetics are more prone to corneal ulcers.  Technology is one thing, however assessing risks vs benefits are important.  There are now skin sensors which accomplish this monitoring feature without the attendant risks of contact lenses.  Skin monitors can also be easily attached to glucose infusion pumps.

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