Citeline Podcasts

In this week’s Medtech Insight podcast, executive editor Shawn M. Schmitt explains how an ongoing "Quality as a Career" initiative from the Medical Device Innovation Consortium (MDIC) is aiming to train the next generation of QA experts.

Medtech Insight articles addressing topics discussed in this episode:

• Quality Desert: How An Academic Minor In Quality Could Be The Key To Quenching Industry's Thirst For QA Professionals

• Device Firms Struggle To Find Qualified Quality Assurance Professionals

Pink Sheet reporters discuss the complete response letter for Sarepta's Duchenne muscular dystrophy drug golodirsen, the Trump administration's appeal of the DTC list price court ruling and the new Business Roundtable statement of purpose.

Pink Sheet reporters assess the implications of the Zolgensma data manipulation announcement, ICER’s findings on the net health benefits of DMD drugs, and the LPAD approval of Pretomanid.

In this edition of Device Week, Medtech Insight managing editor Marion Webb reports on her discussions with diagnostic company executives at the recent American Association for Clinical Chemistry meeting in Anaheim. Senior reporter Catherine Longworth previews her feature on MDisrupt, a new company that touts itself as the world’s first medical diligence company for the healthcare industry.

Medtech Insight articles discussing topics discussed in this episode:

Exec Chat: Deepak Nath, President Of Siemens Healthineers' Laboratory Diagnostics, Offers An Insider's Look At AACC 2019

Survey Suggests 'New Normal' In Securities Suits Against Life Sciences Firms

Theranos' Holmes, Balwani Slammed By SEC For 'Massive Fraud'

Medtech Insight senior reporters discuss the latest safety concerns over cardiac devices such as drug-eluting stents and implantable cardioverter defibrillators. They also cha about the agency’s recently released user fee rates and how they’ve increased historically.

Pink Sheet reporters ask critical questions about the new drug importation framework and assess the FY 2020 US FDA user fee rates.

In this edition of Device Week, Medtech Insight’s Catherine Longworth chats to Marion Webb about the growth of the global hearing aid market which is set to rise from $7.7bn in 2018 to $11bn by 2023. She also speaks to Reed Miller to discuss Zimmer Biomet’s second quarter results and its long-term plan to return to steady growth. 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:

Market Intel: Hearing-Aid Companies' Use Of AI, Apps, New Tech Excites Audiologists; Global Hearing-Aid Market Will Reach $11Bn By 2023:

https://medtech.pharmaintelligence.informa.com/MT125413/Market-Intel-HearingAid-Companies-Use-Of-AI-Apps-New-Tech-Excites-Audiologists-Global-HearingAid-Mar

Zimmer Biomet Continues Turnaround Lead by ROSA Robot: https://medtech.pharmaintelligence.informa.com/MT125441/Zimmer-Biomet-Continues-Turnaround-Lead-by-ROSA-Robot

Zach Rothstein, the top AdvaMed lobbyist tasked with supporting the medical device industry’s interests in artificial intelligence and machine learning, talked to Medtech Insight about how FDA should regulate the fast-growing sector. He argues there likely won’t be a guidance on AI/ML for at least a year and even then the agency may need new congressional authorities for the guidance to come into effect.

No one likes unhappy surprises, especially when it comes to medical billing. In this week's Medtech Insight podcast, executive editor Shawn M. Schmitt and senior reporter Sue Darcey talk about so-called surprise billing by hospitals and other health-care facilities, how legislation wending its way through Congress is aiming to curb it, and why the medtech industry should care.

Medtech Insight articles addressing topics discussed in this episode:

• US Senate Sponsors Push Back Vote On Balanced Billing Legislation To Autumn

• New US State And Proposed Federal Laws Would Stop Specialists From Balance Billing

In this edition of Device Week, Medtech Insight's managing editor Marion Webb chats with deputy editor Reed Miller about recent earning reports from medtech giants Johnson & Johnson and Abbott.

Listen to the podcast via the player below:

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:

Johnson & Johnson Growth Led By Biosense Webster and Cerenovus

Abbott Delivers Strong Q2 Sales, Led By Spike In FreeStyle Libre Sales

Global Device Approvals Snapshot: 9-15 July 2019; MitraClip G4, Relievion, RAPID Imaging, ExAblate Neuro