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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.

With the promise of exciting new devices and services for patients, and lower costs for health services, there are a...

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More from Europe

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 
• By Natasha Barrow

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

Guidance Details EU Approach On Medtech, AI Regulation Interplay

 
• By Amanda Maxwell

Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.

UK MHRA Joins New Global Network For Safe Use Of AI In Healthcare

 
• By Natasha Barrow

The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.

£2Bn Industrial Strategy Boost For UK Life Sciences Growth Sector

 
• By Ashley Yeo

The Modern Industrial Strategy is the first of this summer’s UK blueprints for supporting life sciences industrial activity and transforming NHS healthcare delivery. The UK market must also benefit from its own innovation activity, says industry.

More from Geography

Guidance Details EU Approach On Medtech, AI Regulation Interplay

 
• By Amanda Maxwell

Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.

Tarver And Makary Emphasize Commitment To At-Home Healthcare Innovations In FDA Podcast

 
• By Elizabeth Orr

FDA officials Michelle Tarver and Marty Makary discussed advancements in home healthcare during a podcast. They highlighted the importance of continuous glucose monitors, emphasized home healthcare's benefits for chronic diseases, and mentioned the agency's efforts to streamline device development.

UK MHRA Joins New Global Network For Safe Use Of AI In Healthcare

 
• By Natasha Barrow

The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.