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US FDA Approves First 'Artificial Pancreas' In Medtronic's MiniMed 670G

 
• By Reed Miller

The hybrid closed-loop automated insulin delivery system, the first closed-loop system approved anywhere in the world, automatically monitors glucose and provides appropriate basal insulin doses in people with type 1 diabetes.

A major milestone has been met in diabetes. US FDA announced Sept. 28 the approval of Medtronic PLC's MiniMed 670G hybrid closed-looped automated insulin delivery system.

It's the first hybrid closed-loop insulin delivery system approved anywhere in the world, according to the company, making it the first so-called "artificial pancreas," says FDA

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Edwards Mitral Valve Replacement System SAPIEN M3 Receives CE Mark

 
• By Natasha Barrow

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More from Policy & Regulation

‘Help Us Deregulate’: RFK Announces RFI For Trimming Government Health Agencies

 
• By Brian Bossetta

HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
• By Amanda Maxwell

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

UK Medtech Regulators Must Ensure Certainty So Businesses Can Plan Their Futures

 
• By Ashley Yeo

With medtech businesses typically managing investment cycles on a three- to five-year basis, local regulatory processes and forward costs of market entry must offer an attractive environment in which companies can plan for growth, says McDermott Will and Emery’s partner and head of healthcare and life sciences, Sharon Lamb. Broad-scale improvements to NICE’s evaluation offerings would similarly enhance the UK’s value to innovators.