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

Gaming For Attention: FDA Grants De Novo For Novel ADHD Treatment

Akili Interactive’s EndeavorRx has opened the door for other digital therapies to get to market faster

A new video game pediatric ADHD treatment has opened the door for other such novel therapies to come to market using the less stringent 510(k) pathway, as interest in such products have gained significant steam over the past few years.

Endeavor Soup, video game being used to treat kids with ADHD.
EndeavorRx is the first game-based treatment for children with ADHD, paving the way for other game-based digital treatments under development • Source: Shutterstock/Akili Interactive

For the first time, the US Food and Drug Administration has granted de novo marketing authorization for a game-based digital treatment aimed at children with attention deficit hyperactivity disorder (ADHD). It’s not just the first gaming treatment for ADHD – it’s also the first game-based treatment for any condition to get the nod from the FDA, which opens the door for similar therapies.

Boston-based Akili Interactive’s EndeavorRx video game treatment received the marketing authorization to treat children aged 8 to 12 who suffer...

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

Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
• By Brian Bossetta

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 
• By Amanda Maxwell

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
• By Ashley Yeo

Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.

Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel

More from Policy & Regulation

First AI Breast Cancer Prediction Platform Receives FDA Authorization

 
• By Natasha Barrow

Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.

Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
• By Brian Bossetta

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By Marion Webb

Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.