FDA Watch

2020 Was a Record Year for New Medical Device Approvals—And Not Just for COVID-19

They say that necessity is the mother of invention. But, historically, invention has never been the problem for creators of novel medical devices; the real challenge for these inventors has been more … [Read more...]

LDTs

FDA Clears Neutralizing Antibodies Detection Test for COVID-19

Innovative new COVID-19 tests continue to emerge from the pipeline. One of the novel diagnostic products that has flown slightly under the radar is the cPass SARS-CoV-2 Neutralization Antibody … [Read more...]

Testing Strategy

The Biden Administration Initiates New Plan for National COVID-19 Testing

As with any other aspect of public life, the philosophy and views of the individual occupying the White House ultimately impact the direction of healthcare and diagnostics in the U.S. However, when a … [Read more...]

Special Report

The 5 Things Labs Need to Know about the Biden COVID-19 Testing Plan

Special Report: The 5 Things Labs Need to Know about the Biden COVID-19 Testing Plan Testing labs on the front lines of the COVID-19 battlefield are getting federal reinforcements. And it’s not … [Read more...]

Focus On

How the Transition from Trump to Biden Will Affect Federal Regulation and Reimbursement

“Meet the new boss. . . same as the old boss.” The Who’s “Won’t Get Fooled Again” is a rock classic; but as far as U.S. presidents and federal regulation are concerned, the “new boss” is almost … [Read more...]

Focus On

New Report Sheds Light on Effectiveness of Federal Government’s Response to Need for COVID-19 Testing

Labs, hospitals and other private sector providers have stepped up and performed heroic deeds in meeting the unprecedented demand for COVID-19 testing. State and federal health care agencies from … [Read more...]

Testing Trends

Report Analyzes Federal Health Programs’ COVID-19 Testing Efforts in First Months of Pandemic

The COVID-19 outbreak caught the country and the world totally off guard. And even as the pandemic intensifies, the lessons from those first crucial months hold the key to managing not only … [Read more...]

FDA Watch

FDA Watch: Molecular Tests May Miss New SARS-CoV-2 Strains, Agency Warns

Like many viruses, the SARS-CoV-2 is a shape-shifter. And that may make it harder to detect. With this in mind, the U.S. Food and Drug Administration (FDA) is warning clinical laboratories and health … [Read more...]

Special Report

A New Administration Takes a Totally Different Approach to COVID-19 Testing

Fair or unfair, the general perception has been that the White House has been less than fully supportive of COVID-19 testing efforts during the pandemic. On Jan. 21, his first full day in office, … [Read more...]

FDA

FDA Sounds Alarm on Potential Impact of Genetic Mutation on SARS-CoV-2 Molecular Test Accuracy

As if COVID-19 testing wasn’t challenging enough, the emergence of new variants has made the SARS-CoV-2 virus a moving target. With this in mind, the FDA is warning clinical labs and health care … [Read more...]


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