Citeline Podcasts

Jeff Shuren discussed CDRH’s recent successes and his plans for the remainder of 2020, including priorities for upcoming MDUFA negotiations, in an exclusive interview with Medtech Insight. Check out our podcast or read the transcript.

On this week’s podcast, executive editor Shawn M. Schmitt shares expert tips and advice on how device makers can integrate the recently revised international risk management standard ISO 14971 into their quality systems.

Medtech Insight articles addressing topics discussed in this episode:

• Philips Expert Urges Device Makers: Update Quality Systems To Conform To Revised Risk Standard ISO 14971

• Crosswalk: ISO 14971:2007 Vs. ISO 14971:2019

APAC Podcast Episode 2 – Pharma’s response to coronavirus by Pharma Intelligence

MDMA's Mark Leahey talked with Medtech Insight about repealing the medical device tax, some successes on the reimbursement front and the issues that lie ahead for the medical device industry over the coming year including the upcoming MDUFA negotiations.

Hosted by Andrew McConaghie, Brian Yang and Kevin Grogan from the Scrip Pharma Intelligence team in London and Beijing. Topics covered include what life is really like in China coping with the coronavirus outbreak, Novartis’ groundbreaking work with the NHS in England on its heart disease treatment inclisiran, and the future of Alzheimer’s treatment, including the impending file of Biogen’s aducanumab.

With less than one hundred days left before the European Union Medical Device Regulations kick in, Medtech Insight Executive Editor Ashley Yeo and Managing Editor Amanda Maxwell discuss the growing concern in the medtech industry they may not be ready in time and may inadvertently go afoul of the new regulations.

In this edition of Device Week, Medtech Insight's managing editor Marion Webb talks with deputy editor Reed Miller about his recent story on Abiomed's plan to counter unfavorable study outcomes of its Impella heart pump.

Medtech Insight articles addressing topics discussed in this episode:

AbioMed Launches Plan To Counter Unfavorable Impella Data

https://medtech.pharmaintelligence.informa.com/MT126227/Abiomed-Launches-$100M-Plan-To-Counter-Unfavorable-Impella-Data

Start-Up Spotlight: BioIntelliSense Launches New FDA-Cleared BioSticker For Remote Monitoring Of Patients' Vital Signs

https://medtech.pharmaintelligence.informa.com/MT126231/StartUp-Spotlight-BioIntelliSense-Launches-New-FDACleared-BioSticker-For-Remote-Monitoring-Of-Patien

Knees Boost Zimmer Biomet; Turnaround Continues, But FDA Woes Linger

https://medtech.pharmaintelligence.informa.com/MT126216/Knees-Boost-Zimmer-Biomet-Turnaround-Continues-But-FDA-Woes-Linger

Boston Scientific Expects Up to $40M Impact In Q1 From Coronavirus Outbreak; 10%-12% Revenue Increase For 2020

https://medtech.pharmaintelligence.informa.com/MT126214/Boston-Scientific-Expects-Up-To-40M-Impact-In-Q1-From-Coronavirus-Outbreak-1012-Revenue-Increase-For

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

http://bit.ly/2w7LnlR

As the UK Brexited from the EU on 31 January not much has changed and perhaps much won't change structurally according to Medtech Insight reporter Ashley Yeo but the 11 month negotiations are just getting started between the EU and the UK in terms of how jurisdiction issues will be resolved.

In this edition of Device Week, Medtech Insight’s Catherine Longworth chats to Reed Miller about fourth-quarter 2019 sales and earnings reports coming in from the big medical device companies. She discusses with Reed the findings of a new innovation report published by the UK Medical Technology Group. For more information on Medtech Insight and to start a free trial, click here: http://bit.y/2w7LnlR

Medtech Insight articles addressing topics discussed in this episode:

New Report Calls For UK NHS To Provide Early Access To Medtech

https://bit.ly/2UfZuSu

UK Readies Medtech And Pharma Sectors For Regulatory Life Outside The EU

http://bit.ly/36Ekg0t

J&J Has Big Plans For Robotic Surgery In 2020

http://bit.ly/2O9WfYV

J&J Takes Full Ownership Of Verb Surgical, Verily Breaks Off Robotics Partnership

http://bit.ly/2tnKZAA

Philips Delivers On Aim To Focus Exclusively On Health And Healthtech

http://bit.ly/36EJJ9U

US-China Trade War Hits Philips Connected Care Biz In Q3

http://bit.ly/37DU9YS

In a lengthy exclusive with Medtech Insight, chief of the largest medtech lobby group talked about how they won repealing the medical device excise tax and what’s on the plate for 2020 including reimbursement challenges, negotiating with key governments, ethylene oxide regulation and more.