Citeline Podcasts

On this week's podcast, David Filmore discusses with Shawn M. Schmitt some of important dynamics that will impact medtech regulations globally in 2018, with a focus on the US, Europe and Asia. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR.

Medtech Insight content addressed in this episode:

Interactive Timeline: Global Regulatory Deadlines: http://bit.ly/2An8xn8

5 Ongoing US FDA Device Center Pilot Programs: A Listing: http://bit.ly/2kmlx71

A No-Predicate 510(k) Future? Pending US FDA Policy Might Forge A Path: http://bit.ly/2BAuVLT

Expert Panel: How Manufacturers Are Paying For Notified Body Struggles: http://bit.ly/2iuUMfp

Brexit Roundup: UK Medtech Balancing On A Fault Line: http://bit.ly/2D9qvvS

India Settles On Classifications For Nearly 600 Devices, IVDs: http://bit.ly/2B1hVhe

Malaysia Moves: Asian Medtech Associations Regulatory Networking November 2017, Part I: http://bit.ly/2AY4nCX

On this week's podcast, we discuss our latest MTI 100 rankings, providing a view on top revenue-getters in the medtech space and what issues are driving up and down movements on the list. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR.

The deadline for entries to the CARE Awards is fast approaching! In this podcast, Doro Shin, Head of Pharma Intelligence Thought Leadership, speaks to Citeline’s Executive Director, Karen Currie, chair of the CARE Awards judging panel about how enter and how best to enhance one’s chances to win one of the CARE Awards categories.

On this week’s podcast, we highlight an eye-opening study that shows that the chummier a device-maker is with US FDA investigators, the more likely it is that those firms will experience quality system troubles and face costly product recalls.

In this edition of Device Week, Medtech Insight’s Tina Tan chats to Marion Webb about the ophthalmic surgical devices market, specifically the smallest but fastest-growing segment of micro-invasive glaucoma surgery (MIGS) devices. Marion gives an insight into some of the emerging players in this space and the feedback from clinicians who have used MIGS devices in their practice.

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

Medtech Insight article addressing the topic discussed in this episode:

Micro-Invasive Glaucoma Implants Mark Hottest Growth Spot In Eye Surgery Products Market https://medtech.pharmaintelligence.informa.com/MT121782/MicroInvasive-Glaucoma-Implants-Mark-Hottest-Growth-Spot-In-Eye-Surgery-Products-Market

In this week's podcast, Amanda Maxwell talks about where things stand and the big challenges ahead for implementation of the EU Medical Device and IVD Regulations. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR.

Medtech Insight articles addressed in this episode:

New 'Transitional Measures' Taskforce To Answer EU's Most Critical Questions

EU Roadmap: Catalyst For More Work, And A Long Way To Go

EU Commission May Be Swamped As Notified Bodies Race To Start Line

Combining EU Notified Body MDR/IVDR Assessments: Can It Speed Things Along?

New EU Regs: Clues To Which Notified Bodies Will Be Designated First

In a Medtech Insight exclusive, AdvaMed CEO Scott Whitaker talked about advising Trump HHS nominee Alex Azar on his confirmation process, frustration with permanently repealing the medical device tax, potential for another temporary tax moratorium and lobbying priorities for 2018.

Robotics surgery is one of the hottest and fastest-growing markets that has long been dominated by one player, Sunnyvale, California-based Intuitive Surgical. Medtech Insight sat down with Catherine Mohr, Intuitive’s VP of Strategy, to talk about the new da Vinci Sp, expected to be released in 2018, the competitive landscape and where the innovator foresees new opportunities and technologies ahead.

On this week's podcast, we discuss some cases that might come up in the current session of the US Supreme Court and have an important impact on the device industry – in the realm of patent reviews and consumer and state lawsuits. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR.

Medtech Insight articles addressed in this episode:

US Supreme Court Preview: Cases To Watch For Medtech http://bit.ly/2yN9ZTx

To Change How Courts View 510(k) Clearances, Industry Seeks 'Supreme' Support http://bit.ly/2zpQcsP

Rose Sheet’s editorial team counts down top news items in the cosmetics and dietary supplement sectors over the past month. On the cosmetics side, we discuss the newly proposed FDA Cosmetic Safety and Modernization Act, J&J talc litigation, emerging class action threats, ISO 16128 natural/organic guidelines and EU REACH compliance costs; for dietary supplements, Hi-Tech Pharmaceuticals’ legal woes, Amarin’s failed omega-3 fair-trade complaint, pre-DSHEA ingredients and more.