Devices

FDA Publishes Covid-19 Molecular Test Comparisons

FDA has published comparative performance data for more than 55 authorized molecular diagnostic Covid-19 tests against a standardized sample panel provided by the agency. An FDA statement says it provided the reference panel to test developers who are required to assess their tests’ performance against the panel or other FDA-recommended reference materials as a condition of their emergency use authorization.

The statement says the agency began distributing the reference panel of samples in May and has provided it to more than 150 developers as a resource in the development and validation of accurate and reliable diagnostic tests.

In the published table, a lower limit of detection represents a test’s ability to detect a smaller amount of viral material in a given sample, signaling a more sensitive test, FDA says. However, the data do not indicate how sensitive a particular test is and thus cannot be used by itself to determine whether to authorize a test or to take other regulatory action.

The statement says the data give laboratories, healthcare providers, and patients a new resource on the relative performance of available tests to better inform which tests they choose to use. FDA says it will continue to update the table as it receives additional results.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome