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Home » Authors » Ana Mulero

Articles by Ana Mulero

Sentinel system image

First deployable COVID-19 detection system targets school, workplace safety

June 2, 2021
By Ana Mulero
With the U.S. launch of the first deployable airborne COVID-19 detection system, Bioflyte Inc. is working to provide effective ways to sample the air and deliver results within an hour. The Sentinel integrated solution aims to prevent widespread infection in schools and workplaces.
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Scientists in lab using BD's urine culture analysis imaging application

BD launches AI-powered urine culture analysis application

June 1, 2021
By Ana Mulero
Becton, Dickinson & Co. (BD) is looking to ease the burden on microbiology labs with the U.S. launch of its urine culture analysis imaging application by automating microbiology processes. Powered by artificial intelligence (AI), the app is intended for use on the device manufacturer’s Kiestra lab automation incubation and imaging system.
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FDA icons

FDA revamps postmarket surveillance guidance to increase transparency

May 26, 2021
By Ana Mulero
In an effort to address the longstanding issues with medical device manufacturers failing to comply with Section 522 postmarket surveillance studies, the FDA is looking to revamp 2016 policies in new draft guidance issued on Wednesday. A separate FDA draft document seeks to update guidance on post-approval study requirements for high-risk devices with new policies on procedures and submissions.
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European Commission headquarters

EU MDR clinical investigations guidance puts bandage on EUDAMED’s absence

May 25, 2021
By Ana Mulero
The European Commission's (EC) Medical Device Coordination Group (MDCG) has provided a set of templates to fulfill European Medical Device Regulation (MDR) requirements on submitting clinical investigation application and notification documents in the absence of the European database on medical devices (EUDAMED).
Read More
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