Both CerTest Biotec and Becton Dickinson and Company have received a CE mark for the VIASURE SARS-CoV-2 Real-Time Polymerase Chain Reaction (PCR) Detection Kit adapted for the BD Max System.

The Menlo Park, CA-based company has raised $15 million in a follow-on to its series A round and said it will use the proceeds to support the commercial expansion of its prenatal screening test and help with R&D efforts into a liquid biopsy product.

The ECRI Institute identified these issues as the biggest patient safety concerns in 2020. Can medtech help tackle them?

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Thermo Fisher Scientific is the latest company to be granted Emergency Use Authorization for a diagnostic to detect the coronavirus (COVID-19).

In addition to increasing production of its collection devices, BD worked with BioGX Inc. to request an FDA Emergency Use Authorization for a new COVID-19 diagnostic.

Irvine, CA-based Oncocyte inherited the DetermaIO test when it acquired Insight Genetics earlier this year. The company said it has completed Clinical Laboratory Improvements Amendments (CLIA) validation for the test.

FDA issued a letter to industry that includes steps the agency's Center for Devices and Radiological Health (CDRH) has taken to prioritize work that advances the nation’s response during the Coronavirus (COVID-19) public health emergency.

A new UK-based research consortium is betting that sequencing the virus that causes COVID-19 can provide policymakers with a clearer picture of the spread of the epidemic across the country as diagnostic testing remains limited.

The US Food and Drug Administration on Friday granted Emergency Use Authorization to Luminex for the firm's NxTag CoV Extended Panel to detect SARS-CoV-2 virus nucleic acids in nasopharyngeal swab specimens.

FDA announced that the agency will temporarily postpone all domestic routine surveillance facility inspections, those conducted every few years based on a risk analysis.

On March 5, 2020, Amicus Therapeutics announced the official opening of its new Global Research and Gene Therapy Center of Excellence in Philadelphia, PA, to advance its portfolio of rare disease gene therapy programs.

A new test being developed by Austin, TX-based Astrotech could detect coronavirus (COVID-19) and other lung diseases from the metabolites found in a person’s breath.

Thermo Fisher Scientific is bringing its diagnostic detects nucleic acid from SARS-CoV-2, the virus that causes COVID-19, to Europe. The Waltham, MA-based company said earlier today it had received CE mark for the test.

We are in a challenging time as the COVID-19 pandemic rapidly accelerates in New York City.