FDA Halts Foreign Inspections In a rare action that is sure to impact medical device application reviews, FDA suspended inspections outside the United States through April in response to the coronavirus pandemic. The decision was based on g... Read More >

Tests for the coronavirus (COVID-19) continue to roll in as the U.S. faces a public health crisis. Thermo Fisher Scientific and Mayo Clinic are the latest with diagnostic contributions. Waltham, MA-based Thermo Fisher is the second company... Read More >

BD (Becton, Dickinson and Company) was one of several medtech companies that joined President Donald Trump when he declared a national emergency last week. Several medtech executives detailed their response to the novel coronavirus (COVID-1... Read More >

Oncocyte said it has completed Clinical Laboratory Improvements Amendments (CLIA) validation for its DetermaIO. The Irvine, CA-based company said the diagnostic, which was previously known as the Insight Genetics IM Score Test, is used in l... Read More >

FDA issued a letter to industry that includes steps the agencysCenter for Devices and Radiological Health (CDRH) has taken to prioritize work that advances the nations response during the Coronavirus (COVID-19) public health emergency. The... Read More >

NEW YORK 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. I... Read More >

NEW YORK Pangolins may be an intermediary host for SARS-CoV-2, the virus causing the ongoing COVID-19 pandemic, a new sequencing analysis has found. While bats are thought to be the likely reservoir of SARS-CoV-2, experts suspect another ho... Read More >

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. Amicus and the Univer... Read More >

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 persons breath. The companys BreathTest-1000 is a mass spectrometry technology that was ini... Read More >

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. The test uses Applie... Read More >