FDA Clears Prescription Only ECG Smartwatch
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Posted on Jan 21, 2019, 12 a.m.
Verily has received a 510(k) FDA clearance for its own clinical study smartwatch that comes complete with an on demand single lead ECG, as a prescription only class II device for adults including those known or suspected to have heart conditions.
Michael McConnell writes in the company blog that one area of study for the watch has been cardiovascular health as heart disease remains a top killer in the USA; and suggests the work may provide insights into the utility of integrating mobile health data into the clinical care environment as well as support physician patient relationships.
The company plans to use the FDA cleared version and the investigational versions going forth in future studies; and has recently announced a $1 billion investment round to catapult business developments and potential acquisitions, taking external funding to increase flexibility and optionality as they expand focus areas, to prepare them to execute as healthcare continues to shift towards evidence generation and value based reimbursement models, according to Andrew Conrad, CEO.
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https://blog.verily.com/2019/01/verily-study-watch-receives-fda-510k.html
https://www.fiercebiotech.com/medtech/fda-clears-verily-s-prescription-only-ecg-smartwatch
