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Medtech Insight
By Elizabeth Orr 27 Nov 2020
The US FDA has authorized marketing of a combination diagnostic that can detect either COVID-19 or influenza. The agency hopes to encourage development of additional similar tests before the fall flu season.
Topic Coronavirus Diagnostics In Vitro Diagnostics Regulation
Medtech Insight
By Elizabeth Orr 27 Nov 2020
A new template from the US FDA explains what information the agency wants to see in regulating COVID-19 tests to be performed outside the laboratory environment.
Topic Coronavirus FDA Diagnostics
In Vivo, Medtech Insight
27 Oct 2020
Join distinguished cancer and industry experts as they explore what a shift in cancer treatment – from late stage intervention to an early detection paradigm – would mean for patient outcomes, cancer costs, technology, development, regulatory affairs, and more. Explore this new approach toward focusing on early stage cancer detection, including discussion of diagnostics in this area, such as biomarker identification, liquid biopsies, and monitoring technologies.
Topic Diagnostics Cancer
Medtech Insight
By Marion Webb 25 Sep 2020
FDA clearance of the ASD Diagnostic app could lead to early diagnosis, improving quality of life of children with ASD and their caregivers.
Topic Diagnostics Digital Health FDA
Medtech Insight
By Catherine Longworth 11 Sep 2020
The diagnostics company said the test is scheduled for US launch in Q4 2020.
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