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Kids, Time To Play Your Medicine: Akili Prepares Launch Of EndeavorRx Video Game For ADHD

 
• By Marion Webb

After being first to receive FDA clearance for a prescription-only software to treat ADHD and raising total funding of $230m, Akili plans a US launch in 2022 while targeting other indications.

Video gaming
• Source: Alamy

After nearly a decade building a prescription-based video game platform to help children with attention deficit hyperactivity disorder (ADHD), Akili Interactive Labs’s CEO Eddie Martucci said the company is making plans to market its software to US-based health care providers and patients in the new year.

EndeavorRx became the first prescription-only game-based device to be cleared for marketing by the US Food and Drug Administration under the de novo clearance, the regulatory pathway for low-...

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ConcertAI Launches Generative AI-Powered Precision Suite

 
• By Natasha Barrow

Valued at over $1.9bn, ConcertAI is building on its pre-existing multi-agentic AI SaaS solution CARAai to bring life science customers the new Precision suite of applications: Precision Explorer, Precision Trials, Precision GTM and Precision360.

Handheld Diagnostics: A Resurging Category That is Here to Stay

 
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Handheld diagnostics are more powerful, accessible and clinically relevant than ever. Medtech Insight spoke to companies behind such technologies to learn how they work and discuss their commercial models.

Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 
• By Natasha Barrow

Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

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Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 
• By Brian Bossetta

During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.

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Execs On The Move: 12-23 May 2025

 
• By Medtech Insight Team

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.