FDA issued a letter to the medical device industry regarding steps the Center for Devices and Radiological Health has taken to prioritize work that advances the United States response during the coronavirus public health emergency.

The Abbott Park, IL-based company said it would deploy about 150,000 laboratory tests immediately and wanted to ramp up production to one million tests per week by the end of the month.

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.

Thermo Fisher Scientific is the latest company to be granted Emergency Use Authorization for a diagnostic to detect the coronavirus (COVID-19). Mayo Clinic also announced it has a test that been fully validated and submitted to FDA for review and...

Pressed for time? Here's the medtech news you need most, in one minute or less.

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.

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.

With the acquisition, Waltham, MA-based Thermo Fisher Scientific has the potential to boost its molecular diagnostics offerings. The company also has a chance to expand its coronavirus detection offerings with Qiagen’s QIAstat-Dx Respiratory Panel...