Part one of this series looks at the claims brought against manufacturers of diagnostic test kits.
In order to meet the worldwide need for faster and affordable testing processes, companies must shift goals and apply resources to ending this pandemic.
The authorization is a step toward broad screening that will help reopen schools and workplaces in America, says FDA Commissioner Stephen Hahn, M.D.
Companies developing technologies that integrate AI need to consider regulatory concerns, community demographics, fitting into existing workflows, technical proficiency of both the hospital personnel and consumers.
The winning innovators will receive grant awards of upwards of $50,000.
These countries have been more successful with managing the virus than the United States and the European Union.
COVID-19 is driving patients to seek telehealth solutions, and it won’t be a short-term boom.
The Abbott ID NOW test may return false negative results.
Diagnostic companies are hustling to increase availability of testing.
The agency will continue to work with companies developing diagnostics relevant to the coronavirus outbreak in an effort to rapidly bring technologies to market.