1. HBW Insight
  2. >>Health
  3. >>Innovation & IP
  4. >>New Products

First At-Home Test For Multiple STIs Gets FDA Clearance

 
• By Elizabeth Orr

The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.

Hand holding Visby Sexual Health test kit.
(Visby Medical)

The US Food and Drug Administration has cleared the first at-home test for the detection of multiple common sexually transmitted infections (STIs) in women, creating a new regulatory pathway for similar tests in the future.

The agency announced its de novo clearance of the Visby Medical Women’s Sexual Health Test on 28 March

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW 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 New Products

OTC Marketing Awards 2025 Open For Entries

 
• By Tom Gallen

Find out how to enter the OTC Marketing Awards before the 1 September entry deadline.

Danes Get OTC Access To ED Treatment

 
• By Tom Gallen

Navamedic has launched Eroxon in Danish pharmacies giving men in the country OTC access to an ED treatment for the first time.

First At-Home Test For Multiple STIs Gets FDA Clearance

 
• By Elizabeth Orr

The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.

Haleon Launches ‘Prescription Strength’ Hayfever Remedy In The UK

 
• By David Ridley

Pirilieve Hayfever Relief Tablets contain 120mg fexofenadine hydrochloride, which the firm notes is an active ingredient that was “previously only available behind pharmacy counters.”

More from HBW Insight

US FDA Supplement Office Chief Eyes ‘Movement’ This Year On NDI Notifications Final Guidance

 
• By Malcolm Spicer

“We've made some progress and really hope to see some movement as we move forward this year,” says FDA Office of Dietary Supplement Programs director Cara Welch.

People On The Move: Appointments At ANEPF, Inula, Opella

 
• By Tom Gallen

A round-up of the latest consumer health people moves: ANEFP elects president; Inula Group appoints CEO; Opella names ANZ head.

Over The Counter: Taking Real-World Evidence Seriously, With IQVIA Consumer Health’s Volker Spitzer

 
• By David Ridley

In part 2 of HBW Insight's interview, IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer, explains how to approach real world evidence so that regulators recognize its validity, in supporting Rx-to-OTC switch applications, for example.