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January 2020 Approvals: Medtronic And Abbott Announce DBS Approvals

 
• By Reed Miller

January’s new medical device approvals include the US FDA approval of a new indication for Abbott’s Infinity deep brain stimulation system and a CE mark for Abbott’s Tendyne transcatheter mitral valve replacement system. Medtronic also announced CE marks for a new line of implantable defibrillators and resynchronization devices as well as a CE mark for its Percept PC neurostimulator.

Approved stamp

The US Food and Drug Administration approved three original premarket approvals (PMA) and one panel-track PMA supplement in January 2020.

The noteworthy novel device approvals in January included the CE mark for Abbott Laboratories’ Tendyne transcatheter mitral valve replacement system. With this approval, Tendyne becomes the first transcatheter mitral...

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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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UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
• By Ashley Yeo

Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.

Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 
• By Natasha Barrow

Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.

BD To Shift China-Facing Production, Ramp Up US Output With $2.5B To Counter Tariff Blow

 
• By Shubham Singh

BD is accelerating transitions of product sourcing for China to avoid tariffs. Historically, products like Vacutainer were exported from Sumter, SC, to China, and Flush was shipped from Columbus, NE.