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Medtronic Receives CE Mark For World’s Smallest Pacemaker

Medtronic’s Micra Transcatheter Pacing System is not only the world’s tiniest approved pacemaker, but the vitamin-sized transcatheter device also has no leads and is cosmetically invisible. The pacemaker targets patients with a slow heartbeat who can benefit from single-chamber pacing.

The world’s smallest pacemaker, the Micra Transcatheter Pacing System (TPS) from Medtronic PLC received CE mark in April. The mere size of a large vitamin, with a likely battery life of 10 years, the device is indicated for patients with bradycardia, a condition characterized by a slow heartbeat (fewer than 60 beats per minute). The company expects US Food and Drug Administration Premarket Approval for the device during fiscal year 2017 (between May 2016 and April 2017). (See Exhibit 1.)

Exhibit 1

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Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Ryan Nelson

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Ryan Nelson

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.

Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
• By Marion Webb

Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 
• By Natasha Barrow

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

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Commission Decision Launches Pediatric And Rare Disease Expert Group

 
• By Amanda Maxwell

A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.

US CMS Sets Out Competitive Bidding Rental Model for CGMs; Abbott, Dexcom Could Face Impact

 
• By Shubham Singh

CMS is proposing to classify all CGMs and insulin pumps as “items requiring frequent and substantial servicing” to expand device choice and access for Medicare beneficiaries. Under this framework, CMS also intends to move Class II devices, which include CGMs from Abbott and Dexcom and pumps from Tan

Dermal Fillers For Décolletage May Gain FDA Approval

 
• By Elizabeth Orr

An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.