Medtech Insight

FDA Clears CDC Diagnostic For COVID-19 And Influenza

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

FDA Boosts Development Of OTC COVID-19 Tests With New Template

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

Transforming Cancer Treatment with Early Detection Diagnostics: Opportunities And Obstacles Webinar

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

Cognoa Seeks De Novo Clearance For AI-Powered Diagnostic App For Autism After Successful Study

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

Qiagen Ready To Rival Abbott With Rapid Portable Antigen COVID-19 Test

The diagnostics company said the test is scheduled for US launch in Q4 2020.

Topic Coronavirus Diagnostics In Vitro Diagnostics