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Neuronetics Gets Expanded Clearance For TMS Therapy System

 
• By Brian Bossetta

The US FDA has cleared the NeuroStar transcranial magnetic stimulation system to treat depression in adolescents 15 through 21, making it the first and only such treatment the agency has cleared for this age group.

Depression
• Source: Shutterstock

The Food and Drug Administration has cleared the NeuroStar transcranial magnetic stimulation system (TMS) from Neuronetics as an adjunct treatment of major depressive order in adolescents, the company recently announced.

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More from Policy & Regulation

Congress, Researchers Highlight Security Risks At DNA Testing Services

 
• By Elizabeth Orr

Congress has launched an inquiry into 23andMe amid privacy concerns following its bankruptcy, particularly regarding the potential sale of sensitive user data. Additionally, a Cybernews report gave 40 DNA testing firms an average cybersecurity grade of D, citing widespread vulnerabilities and data breaches, along with inadequate public information about their security practices.

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Will challenges in the way of designations of notified bodies that assess AI-enabled medical devices create delays and bottlenecks and slow EU medtech innovation?

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• By Elizabeth Orr

Many of the hundred-plus commenters to the FDA's draft guidance on AI in medical product regulation said the document was a good start but needed additional clarity and more concrete examples. Stakeholders recommended the inclusion of case studies, metrics, and clearer guidelines to enhance the utility of the guidance, which is seen as a vital step for AI integration in healthcare.