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Friday, March 20, 2020

FDA relaxes standards for remote vital sign monitoring

In a further action to help address the COVID-19 outbreak, the FDA will allow manufacturers of certain FDA-cleared non-invasive vital sign-measuring devices to expand their use to include remote patient monitoring.
The policy, limited to the duration of the emergency, applies to modifications pertaining to indications, claims, functionality, hardware or software.
Selected tickers (some more pertinent than others): Masimo (MASI -2.6%), Edwards Lifesciences (EW -3.7%), Philips (PHG -4.4%), Nihon Kohden (OTC:NHNKF), Hill-Rom (HRC -4.7%), GE (GE +3.4%), OSI Systems (OSIS -4.6%)
https://seekingalpha.com/news/3553898-fda-relaxes-standards-for-remote-vital-sign-monitoring

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