1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

First Anti-Addiction App Approved In The US

Pear Therapeutics' reSET mobile application to treat substance addictions in combination with outpatient therapy programs has been approved by US FDA. The agency approved the software after a multi-site clinical trial showed patients were significantly more successful remaining abstinent after using the app.

US FDA has green-lighted the first mobile software application to help treat substance use disorders (SUD). Pear Therapeutics' reSET software received de novo go-ahead as prescription-only adjunct treatment for patients undergoing outpatient therapy to treat alcohol, cocaine, marijuana and stimulant SUDs.

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 Regulation

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 
• By Amanda Maxwell

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

Medtech Seeks Inclusion In EU’s Groundbreaking Life Sciences Strategy

 
• By Amanda Maxwell

As the EU Life Sciences Strategy aims to drive innovation, the medtech sector is pushing for a pivotal role in a mission intended to embrace green and digital transitions, address regulatory obstacles and reduce dependency on external sources.

‘The FDA Will Be Looking For Avenues To Regulate Laboratory Developed Tests’

 
• By Natasha Barrow

The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.

Update: Italy’s IMQ And Belgium’s SGS Named 15th and 16th IVDR Notified Bodies

 
• By Amanda Maxwell

Ireland’s NSAI reinstated under IVD Regulation designation list

More from Policy & Regulation

Former FDA Head Tells Heart Society To ‘Get Involved’ To Protect Health Innovation

 
• By Elizabeth Orr

Former FDA Commissioner Robert Califf urged the Heart Rhythm Society to engage actively amid federal funding cuts. He highlighted collaboration among researchers, advocates for healthcare integration, and the importance of addressing social determinants of health, while discussing lobbying strategies and the challenges faced by medtech companies.

Q’Apel Medical Recalls, Discontinues Stroke Therapy System After FDA Warning Letter, Class I Designation

 
• By Brian Bossetta

Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.

‘The FDA Will Be Looking For Avenues To Regulate Laboratory Developed Tests’

 
• By Natasha Barrow

The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.