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Latest From Ellume

Recall Of Millions Of Ellume COVID-19 Tests High-Risk Class I, FDA Says

Ellume recalled 2,212,335 of the home tests because there’s a chance they can give false-positive results.

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Digital Health Roundup, March 2021: Record-Breaking Funding; Exec Chats With Medtronic, Edwards LifeSciences

In this new roundup feature focusing on the most notable developments in digital health, we pick the key news to date.

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First COVID-19 At-Home Test That Doesn’t Require A Prescription Authorized By The FDA

Ellume Health’s COVID-19 Home Test isn’t just a relatively fast, accurate and easy-to-administer antigen diagnostic, but it’s also available over-the-counter, which greatly expands public access to such tests.

United States FDA

First COVID-19 At-Home Test That Doesn’t Require A Prescription Authorized By The FDA

Ellume Health’s COVID-19 Home Test isn’t just a relatively fast, accurate and easy-to-administer antigen diagnostic, but it’s also available over-the-counter, which greatly expands public access to such tests.

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