1. Medtech Insight
  2. >>Device Area
  3. >>Diagnostics
  4. >>In Vitro Diagnostics

OTC Tests For Flu, Strep, STIs Up For Discussion At FDA Panel Meeting

 
• By Elizabeth Orr

Panelists will look at the benefits and risks of over-the-counter diagnostics for influenza, strep throat and sexually transmitted infections. The meeting is being held in response to sponsor queries about new test designs.

An Aug. 16 US FDA advisory panel meeting could facilitate the pathway to market for over-the-counter (OTC) tests for the flu, strep throat and certain sexually-transmitted infections – if members of the agency’s Microbiology Devices Panel can agree on what safety precautions are needed.

Few diagnostics, and, in particular, infectious disease diagnostics, are currently available over-the-counter. One exception is OraSure Technologies Inc.’s OraQuick...

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
Start Free Trial

Already a subscriber?

More from In Vitro Diagnostics

Abbott Lowers Outlook But Headwinds Are Temporary

 
• By Natasha Barrow

Despite headwinds, executives remain optimistic about growth in Abbott’s medical devices and diabetes divisions and plan several product rollouts, including the Volt PFA catheter for electrophysiology and the dual glucose-ketone sensor CGM.

Waters’ Purchase Of BD Biosciences & Dx Brings Growth Potential Alongside Trade-Offs

 
• By Marion Webb

Waters Corp. will acquire Becton Dickinson’s Biosciences and Diagnostics business for $17.5bn, doubling its TAM to $40B. Analysts praise the flow cytometry addition but see weaker growth in diagnostics.

Thena Capital’s New Fund Up And Running With £1M Investment In Plexāā’s Breast Cancer Device

 
• By Natasha Barrow

Thena Capital, the first UK-based early-stage specialist medtech firm, has made its first investment since closing its £50m fund. Medtech Insight spoke with general partner Pamela Walker Geddes to gain insight into Thena Capital’s investment strategy.

Milner Pitch Day: Multiomic Pathology, Microcancer Avatars And Cell Morphology Intelligence

 
• By Natasha Barrow

The Milner Institute, the on-campus hub for start-up acceleration at Cambridge University, hosted its annual Pitch Day on July 1. Start-ups Panakeia, PathwayBio and Sentinal4D presented diagnostic technologies.

More from Diagnostics

Abbott Lowers Outlook But Headwinds Are Temporary

 
• By Natasha Barrow

Despite headwinds, executives remain optimistic about growth in Abbott’s medical devices and diabetes divisions and plan several product rollouts, including the Volt PFA catheter for electrophysiology and the dual glucose-ketone sensor CGM.

‘Eyes – A Window Into The Heart’: Retinal AI Tool Predicts Future Risk Of Heart Attack And Stroke

 
• By Natasha Barrow

A deep-learning AI-based retinal image scanning tool can predict the risk of cardiovascular events over a 10-year period with 70% accuracy. The test is comparable to routine GP health checks, researchers from the University of Dundee have shown.

Whoops! FDA Says Company Marketed Unauthorized Device. The Company Says The FDA Is Wrong

 
• By Brian Bossetta

A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.