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FDA Approves Medtronic’s 'Extra-Vascular' ICD, The First Of Its Kind

 
• By Reed Miller

The Aurora EV ICD system provides anti-tachycardia pacing, cardioversion and defibrillation therapies through a lead placed under the breastbone, outside of the heart and veins.

• Source: Shutterstock

Medtronic’s Aurora EV ICD system will be the first extravascular implantable cardioverter defibrillator available in the US.

On 23 October, the US Food and Drug Administration approved Aurora to provide defibrillation shocks, anti-tachycardia pacing (ATP), and back-up (pause-prevention) pacing

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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.