The US Food and Drug Administration on Thursday said it has granted Emergency Use Authorization for Detect's over-the-counter, at-home SARS-CoV-2 test.

The US Food and Drug Administration last week granted Emergency Use Authorization for InBios International's SCoV-2 Detect Neutralizing Ab ELISA immunoassay for SARS-CoV-2.

Cell fitness has been identified as a way of predicting health outcomes in COVID patients, according to a University of Queensland study.

The US Food and Drug Administration last week granted Emergency Use Authorization for Lighthouse Lab Services' CovidNow SARS-CoV-2 Assay.

FDA clearance for a watch it says is capable of detecting atrial fibrillation through a medical-grade ECG and measuring blood oxygen levels from the wrist.

Agilent Technologies Inc. today announced its Ki-67 IHC MIB-1 pharmDxis now FDA approved as an aid in identifying patients with early breast cancer at high risk of disease recurrence, for whom adjuvant treatment with Verzenio® (abemaciclib) in combination with endocrine therapy is being considered.

FDA brought medtech up to speed on several key medical device programs during the CDRH Townhall at The MedTech Conference.

Laboratory Corporation of America said on Friday that it has received Emergency Use Authorization from the US Food and Drug Administration for a combined home collection kit for molecular testing for COVID-19 and influenza A/B.

ANP Technologies announced on Monday that its SARS-CoV-2 rapid antigen test has received Emergency Use Authorization from the US Food and Drug Administration.

On September 23, FDA sent a letter to all manufacturers that received EUA authorization for COVID-19 tests, urgently notifies all these manufacturers of three new requirements for their EUA-authorized tests.