Medtech Insight: 世界の医療機器・医療技術の最新情報

FDA Clears CDC Diagnostic For COVID-19 And Influenza

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: 世界の医療機器・医療技術の最新情報

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

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: 医療用医薬品・医療機器産業の経営層向けニュース, Medtech Ins...

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

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: 世界の医療機器・医療技術の最新情報

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

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: 世界の医療機器・医療技術の最新情報

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

11 Sep 2020

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

Topic Coronavirus Diagnostics In Vitro Diagnostics