Device manufacturers may see the EU MDR extension as an opportunity to take their collective feet off the gas. But slowing down or pausing a device’s testing program could jeopardize a successful transition and exacerbate the problem the deadline extension was designed to fix.
The test generates results within 20 minutes and can be used by adults and children over the age of two years old.
The real-time bioaerosol sampling system can detect a very low concentration of SARS-CoV-2 in the air.
Incorporating bioinformatics platforms can ease the burden of tracking, analyzing and managing the use of antibiotics.
A return to normalcy requires us to address the limits of current testing approaches and broadly deploy reliable screening tools that facilitate early detection and encourage more focused testing of those at high-risk of spreading the coronavirus.
The PCR and real-time PCR molecular diagnostics was valued at $4 billion in 2019.
Part one of this series looks at the claims brought against manufacturers of diagnostic test kits.
Companies can improve their chances for a successful transition by leveraging their knowledge of their medical devices and understanding what each device’s categorization under the MDR means to its testing strategy.
In order to meet the worldwide need for faster and affordable testing processes, companies must shift goals and apply resources to ending this pandemic.
AdvaMed’s Diagnostic Supply Registry is tracking the progress of molecular diagnostic tests to help support state and federal governments.