Abbott Receives Emergency Use Authorization For COVID-19 Test

Abbott has become the next major diagnostics company to receive an Emergency Use Authorization from the US FDA for a COVID-19 test.  

MT1901_Abbott_ 712414345 _1200.jpg

The US Food and Drug Administration has issued Emergency Use Authorization (EUA) to Abbott Laboratories Inc. for a COVID-19 test, the company announced 18 March.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from In Vitro Diagnostics

‘First Liver Cancer Surveillance Test In Five Years Receives FDA Breakthrough Status’

 

Cambridge-based startup Mursla Bio's liquid biopsy test EvoLiver uses extracellular vesicles to detect hepatocellular carcinoma (HCC) in high-risk cirrhotic patients. Medtech Insight sat down with with Mursla Bio CEO Pierre Arsène.

OneCell Diagnostics – Now 1Cell.Ai - Launches Multi-Modal Cancer Diagnostic Panel OncoIncytes

 

OneCell Diagnostics, the Mumbai-based startup backed with $16m in series A funding, is rebranding to 1Cell.Ai to represent the firm's focus on combining deep science with AI-powered capabilities.

Diagnostics Are Essential, But How Can Companies Ensure A Fair Price?

 

Biotech and pharma are increasingly clear about one thing: They need diagnostics. But with prices suppressed, how have diagnostics companies proven their utility without going under?

End Of The Road? Court LDT Decision May Leave FDA With Few Options

 

Now that a federal judge has ruled the US FDA exceeded its authority by unilaterally assuming regulatory oversight of lab-developed tests, what’s the agency’s next move? And does it really have one?

More from Diagnostics

Gleamer Charts Multi-Modality Future With FDA Nod And MRI Acquisitions

 
• By 

ChestView, Gleamer’s newly FDA-cleared solution, is designed for chest X-ray interpretation and is the latest addition to its Gleamer Copilot suite. ChestView, which operates as a computer-aided detection system that can simultaneously detect multiple pathologies on images to support radiologists, is being rolled out in the US.

Anglonordic 25: Pictura Bio’s One-Minute Pathogen-Identifying Diagnostic Test

 

“Infectious disease should be treated in the community, not in hospitals,” Alex Batchelor, Pictura Bio CEO, told Medtech Insight at the Anglonordic Life Science Conference on 3 April in London.

Birmingham City University Develops New Defense Mechanism Against Cyberattacks On AI Systems

 

AI systems used in healthcare are vulnerable to adversarial cyberattacks, which are a growing concern, said Atif Azad, a professor of AI at Birmingham City University. Azad’s research group has developed a method that trains AI to become more resilient to cyber threats through the use of random image adjustments.