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How “Regulatory Sandboxes” Offer Hope For New Technologies That Don’t Fit The Regulatory Mold

 
• By Amanda Maxwell

Globally, a new regulatory approach is being adopted increasingly frequently to understand and manage the growing number of cutting-edge medical technologies that sit uncomfortably within current regional or local regulatory structures.

Child playing with his truck toy on a sunny summer day sandy background.
A Safe Space For Regulators, Industry And Other Stakeholders To Play With Innovative Device Concepts • Source: Shutterstock

The pace of medtech innovation seems inexorable. So much advanced technology is becoming available, including through digital health and artificial intelligence, which is revolutionizing the way medical devices and IVDs are being designed and used. Medtech products that do not sit well within the confines of current regulatory environments are becoming increasingly commonplace.

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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

Notified Bodies Warn Of Hurdles In The Way Of Their AI Designations

 
• By Amanda Maxwell

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?

Keeping Germany’s Medtech Industry Apprised, Advised and Incentivized in Turbulent Times

 
• By Ashley Yeo

A change of government, hospital reform and a drive towards healthcare digitization are keeping German medtech manufacturers on their toes. Making the MDR more user-friendly and winning support for a medtech strategy are arguably bigger priorities. US export tariffs have also pushed their way onto the agenda. BVMed chief executive Marc-Pierre Möll puts it all into context.

Edwards Mitral Valve Replacement System SAPIEN M3 Receives CE Mark

 
• By Natasha Barrow

“We believe [the SAPIEN M3] launch alongside PASCAL and EVOQUE will help support the company’s target of $2bn in transcatheter mitral and tricuspid therapies sales by 2030,” noted analysts from Leerink Partners.

More from Geography

Upcoming CMS Meetings Address Tremor-Control Devices, Lab Test Reimbursement

 
• By Elizabeth Orr

The US Medicare agency will hold three public meetings in June and July addressing tremor treatment devices and clinical diagnostic lab tests. The first meeting on June 25 will focus on endpoints for Parkinson’s device trials, while subsequent meetings will address payment rates and codes for laboratory tests.

Trump’s Preliminary 2026 HHS Budget Plan Protects US FDA User Fee Collection

 
• By Cathy Kelly

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

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.