Citeline Podcasts

On this week’s podcast, Medtech Insight’s Ferdous Al-Faruque and Shawn M. Schmitt discuss “The Bleeding Edge,” a new Netflix documentary by Oscar-nominated director Kirby Dick that is highly critical of the medical device industry and US FDA.

Medtech Insight article addressing topics discussed in this episode:

• Top Medtech Lobbyist Doubts Legislative Repercussions Of New Netflix Documentary https://bit.ly/2wmlb6t

Susan Van Meter, executive director of AdvaMedDx, sat down with Medtech Insight to talk about what she’s learned in the nine months on the job and what issues she’s focusing on to represent the interests of the diagnostics industry.

The medtech industry’s number one player, Medtronic, is the focus of this edition of Device Week, as the firm hit the headlines with some impressive first fiscal quarter results and positive data from a trial of its Synchromed II drug infusion pump. Medtech Insight’s Reed Miller and Tina Tan chat about what helped to boost the company’s top- and bottom-lines and delve deeper into the SISTERS trial for Synchromed and the impact these results will have on the company’s pain management business.

For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR

Medtech Insight articles addressing topics discussed in this episode:

Medtronic's Eyes Are Still Peeled For M&A, But Organic Growth Is The Primary Goal

Positive SISTERS Data Could Lift Medtronic's SyncroMed II From Recall Repercussions

https://medtech.pharmaintelligence.informa.com/articles/2018/08/21/medtronics-eyes-are-still-peeled-for-ma-but-organic-growth-is-the-primary-goal

On this week’s podcast, Medtech Insight’s Shawn M. Schmitt talks about his recent reporting on US FDA’s plans to merge its bedrock rule for manufacturing safe and effective devices in the United States with international quality systems standard ISO 13485.

Medtech Insight article addressing topics discussed in this episode:

• QSR Author Kim Trautman Predicts What A Mash-Up Of FDA's Quality System Regulation And ISO 13485 Might Look Like https://bit.ly/2wbVDbg

• The QSR/ISO 13485 Maze: How FDA's Satellite Device Rules Will Complicate A Quality System Regulation Rewrite https://bit.ly/2w9ONTx

• US FDA Commissioner: Agency Will Propose New Rule That Blends Quality System Regulation, ISO 13485 https://bit.ly/2IwdTnK

Medtech Insight caught up with FDA’s Vasum Peiris immediately after a two-day workshop on pediatric medical devices to discuss what the agency learned and how the field may change based on the discussions.

In this edition of Device Week, Medtech Insight's Reed Miller chats with Marion Webb about her latest Market Intelligence story focusing on the liquid biopsy market and emerging companies.

For more information on Medtech Insight and to start a free trial, click here:

http://bit.ly/2w7LnlR

Medtech Insight articles addressing topics discussed in this episode:

Market Intel: Liquid Biopsy I - Analyzing Market Landmarks and Landmines

https://bit.ly/2w6lEZz

On this week’s podcast, Medtech Insight’s Catherine Longworth and Ferdous Al-Faruque talk about surgical guidance company Endomag, which recently secured a landmark approval from US FDA for its combination breast cancer product Sentimag and Magtrace.

Medtech Insight article addressing topics discussed in this episode:

New Cancer Center Played Pivotal Role In Endomag's Success https://bit.ly/2MzCl6u

US FDA's new Oncology Center for Excellence brought in key experts to help review and approve Endomag's new Magtrace and Sentimag System combination product to help surgeons trace and remove breast tumors. The case highlights how disease-specific centers could change the way the agency reviews products.

Device Week, Aug. 1, 2018 – A Closer Look At Cancer Surgical Ablation

In this edition of Device Week, Medtech Insight’s Tina Tan chats to finds out more about the fast-growing market for surgical ablation devices to treat cancer. Marion Webb gives an insight into the speed at which the market is expanding and who are the emerging innovators. Catherine Longworth then discusses in more detail one of the more established players in this field, Medtronic, which has installed its Visualase system in the UK for the first time after getting a CE mark recently.

For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR

Medtech Insight articles addressing topics discussed in this episode:

Market Intel: New Thermal Therapies Blaze Trail In Fast-Growing Cancer Ablation Market - https://bit.ly/2vpr6GA

Medtronic's Visualase Tumor Ablation Tech Beams Into UK Market - https://bit.ly/2LRkaMx

On this week's podcast, Reed Miller talked about the Medicare Evidence Development & Coverage Advisory Committee's recent gathering to discuss transcatheter aortic valve replacement coverage policies and the debate over hospital and physician volume requirements. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR.

Listen to the podcast via the player below:

Medtech Insight articles addressing topics discussed in this episode:

Medicare Advisors Mostly Favor TAVR Center Volume Thresholds: https://bit.ly/2K1pmII

CMS Is Taking Another Look At Its TAVR Coverage Rules: https://bit.ly/2vevpEK

CMS Policy Sets Boundaries On Transcatheter Valve Procedure: https://bit.ly/2AhBC8u