Medtech Insight: global medical technology news & analysis
Warning Letter Close-Outs – February 2021
01 Mar 2021
No device-related close-out letters were released by the US FDA last month.
Abbott Laboratories Inc.is launching a new portable point-of-care test that can detect COVID-19 within five minutes, the company announced on March 27.
The new test, ID NOW COVID19, will run on Abbott’s portable POC platform ID NOW and deliver positive results in as little as five minutes, the company says. Negative results are delivered in thirteen minutes.
The test has been issued an emergency use authorization (EUA) by the US Food and Drug Administration and is expected to be available in the US this week.
As the pandemic unfolds, there have been repeated calls to increase availability of rapid testing. POC tests such as Abbott’s ID NOW may play an important role in diagnosing infection, but the sensitivity and specificity of these rapidly developed tests are also being questioned.
It is the second COVID-19 test to receive an EUA. Last week Abbott launched the Abbott m2000 RealTime SARS-CoV-2 test. Between the two platforms, Abbott said it expects to produce about 5 million tests per month. (Also see "Abbott Receives Emergency Use Authorization For COVID-19 Test" - Medtech Insight, 19 Mar, 2020.)
[Editor’s note:Medtech Insight is tracking the global diagnostic pipeline of COVID-19 tests. See ourCOVID-19 test trackerfor a full listing.]
Medtech Insight: global medical technology news & analysis
01 Mar 2021
No device-related close-out letters were released by the US FDA last month.
Medtech Insight: global medical technology news & analysis
By Sue Darcey 01 Mar 2021
The White House will be spending $86m to provide tens of millions of coronavirus masks to poorer American households.
Medtech Insight: global medical technology news & analysis
By Reed Miller 01 Mar 2021
Local Medicare carrier Novitas met with monitoring companies to discuss rates for long-term ECG monitoring, but no final decision on...
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