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Citeline Podcasts

1,366 episodes - English - Latest episode: 3 days ago - ★★★★★ - 24 ratings

Citeline places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and information together with penetrating insight and analysis. Citeline is a leader in the field of healthcare industry information.

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Episodes

OTC Podcast Recording 2020

October 15, 2019 08:30 - 6 minutes - 3.05 MB

Get the most out of your entry into the 2020 OTC Marketing Awards with our latest podcast. Listen to find out more about the categories and how to enter.

Device Week, 11 October 2019 – Total Recall: The Latest On Corrections & Removals

October 11, 2019 20:43 - 10 minutes - 19.5 MB

On this week’s podcast, executive editor Shawn M. Schmitt and senior reporter Elizabeth Orr delve into recent news on medical device recalls, including tips and advice from US FDA officials, and a report about a new app that scans products and gives detailed safety and recall information. Medtech Insight articles addressing topics discussed in this episode: • 'SoomSafety': How A Real-Life Recall Scare Led A Father To Develop A Free App That Gives Detailed Device Safety Info https://medtech.ph...

Celltrion’s Subcutaneous Infliximab And The Future Of Biosimilars

October 11, 2019 07:55 - 20 minutes - 18.4 MB

Celltrion’s Subcutaneous Infliximab And The Future Of Biosimilars by Informa

Device Week, 4 October 2019 – Demant Group Recovers From Cyber-Attack; TCT Conference Highlights

October 04, 2019 18:43 - 6 minutes - 11.6 MB

In this edition of Device Week, reporter Catherine Longworth provides an update on how Demant Group is recovering from a ransomware attack that forced the Danish hearing aid manufacturer to shut down its IT systems. Deputy editor Reed Miller reviews the highlights from the clinical trial presentations at the recent Transcatheter Cardiovascular Therapeutics conference in San Francisco. Listen to the podcast via the player below: Medtech Insight articles addressing topics discussed in this ...

Makena's Accelerated Approval At Stake, Woodcock On Biobetters And Singulair's Safety Issues

October 03, 2019 21:21 - 16 minutes - 26.1 MB

Pink Sheet reporters discuss the potential withdrawal of Makena’s accelerated approval, CDER director Janet Woodcock’s remarks on the development of biobetters and the advisory committee meeting on the neuropsychiatric events safety risk for Merck’s Singulair.

Device Week, 27 September 2019 – Guidance, Guidance Everywhere...

September 27, 2019 18:35 - 7 minutes - 13.8 MB

The US FDA has been furiously releasing a boatload of updated, draft and new guidance documents over the past month. On this week’s podcast, we discuss three of them, related to clinical decision support (CDS) software, Humanitarian Use Devices (HUD) and Humanitarian Device Exemption (HDE). Medtech Insight articles addressing topics discussed in this episode: • Industry Optimistic About Second CDS Draft Guidance; FDA Releases More Final Software Guidances • New FDA Guidance Expands HUD Patien...

FDA Launches Project Orbis, Mulls Expansion Of ADFs And Touts Rare Disease Cures Accelerator

September 20, 2019 20:38 - 15 minutes - 14.3 MB

Pink Sheet reporters discuss the US FDA's launch of its Project Orbis collaboration, the agency's call for comments on the development of abuse-deterrent formulations for central nervous system stimulants and the new Rare Disease Cures Accelerator.

Device Week, Sept. 20, 2019 – Medtech Giants Sign Major Diabetes Partnerships

September 20, 2019 12:36 - 10 minutes - 18.5 MB

Device Week, Sept. 20, 2019 – Medtech Giants Sign Major Diabetes Partnerships by Informa

Device Week, 13 September 2019 – Feathering The NESTcc

September 13, 2019 19:43 - 7 minutes - 13.5 MB

In this week’s Medtech Insight podcast, senior reporter Elizabeth Orr gives the skinny on the latest developments surrounding the National Evaluation System for health Technology Coordinating Center, or NESTcc. Medtech Insight article addressing topics discussed in this episode: • NESTcc Updates On Projects, Prepares For Winter Launch https://medtech.pharmaintelligence.informa.com/MT125627/NESTcc-Updates-On-Projects-Prepares-For-Winter-Launch

AI Technology And Navigating The HIPAA Minefield

September 12, 2019 21:11 - 16 minutes - 18.9 MB

DLA Piper’s Danny Tobey recently spoke with Medtech Insight about how patient privacy regulations under HIPAA may impact medtech products that use AI technology. He notes depending on the case, some companies may need to comply with HIPAA for one business division but not another based on how they are set up.

Opioid Litigation And Approvals, Rare Disease Legalese In Focus

September 12, 2019 21:08 - 12 minutes - 8.69 MB

Pink Sheet Reporters discuss Purdue Pharma's pending settlement on the opioid crisis, the FDA's review of future opioid applications and a proposal to better describe rare disease flexibility.

Device Week, 6 September, 2019 – Connected Health Summit's Digital Health Focus;

September 06, 2019 21:02 - 8 minutes - 15.5 MB

In this edition of Device Week, Medtech Insight's deputy editor Reed Miller chats with managing editor Marion Webb about her digital health coverage at the recent Connected Health Summit in San Diego. And London, UK-based senior reporter Catherine Longworth talks about her visit with Intuitive Surgical at their new training suite in Oxford. Listen to the podcast via the player below: Medtech Insight articles addressing topics discussed in this episode: Smart Homes, AI-Assisted Devices, Home...

Sharpless On His Future And Zolgensma's Problems, Mylan's Insulin Complete Response

September 06, 2019 16:19 - 26 minutes - 24.2 MB

Pink Sheet reporters discuss Acting FDA Commissioner Norman Sharpless' future, his comments on the Zolgensma data manipulation scandal, and a setback in Mylan's efforts to move a follow-on insulin application.

Ed Cox Departs FDA, J&J Loses Opioid Lawsuit And Industry Comments On Clinical Study Reports

August 30, 2019 14:44 - 19 minutes - 13.2 MB

Pink Sheet reporters discuss Ed Cox's departure from the FDA to Regeneron, Johnson & Johnson's defeat in an opioid lawsuit and industry comments on the FDA's proposal to release clinical study reports.

Device Week, 30 August 2019: Desperately Seeking Quality Assurance Professionals

August 30, 2019 14:09 - 9 minutes - 17.1 MB

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 Professio...

Golodirsen Rebuffed and DTC Ad Lawsuit Revamped

August 22, 2019 20:59 - 18 minutes - 12.6 MB

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 Pharma Regulatory Podcast: Zolgensma Data Manipulation, ICER's Assessment of DMD Drugs

August 15, 2019 21:32 - 19 minutes - 13.7 MB

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.

Device WeekDevice Week, 8 August 2019 – AACC Recap; MDisrupt Helps Investors Navigate Medtech

August 15, 2019 20:58 - 7 minutes - 14.5 MB

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, Presiden...

Device Week 9, Aug. 2019: Concerns Over Cardiac Devices, US FDA Drops User Fees

August 08, 2019 21:17 - 6 minutes - 7.19 MB

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 Pharma Regulatory Podcast: Drug Importation and FY 2020 User Fees

August 02, 2019 16:13 - 22 minutes - 15.5 MB

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

“Device Week, 2 Aug. 2019 – Global Hearing Aid Market Growing Fast; Zimmer Continues Turnaround”

August 02, 2019 11:33 - 10 minutes - 19.9 MB

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 epi...

AdvaMed’s Rothstein Discusses FDA’s AI Future

July 29, 2019 21:20 - 19 minutes - 15.7 MB

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.

Device Week, 26 July 2019: Surprise! Enjoy Your $20,000 Medical Bill For A Broken Arm

July 26, 2019 19:57 - 8 minutes - 15.2 MB

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...

Device Week, 19 July, 2019 –All About Earnings:Johnson&Johnson's Leadership Remains Positive

July 18, 2019 23:33 - 8 minutes - 16.4 MB

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 S...

Pink Sheet Regulatory Podcast Episode 9

July 18, 2019 19:43 - 18 minutes - 12.6 MB

Pink Sheet Regulatory Podcast Episode 9 by Informa

Pink Sheet Regulatory Podcast Episode 8

July 11, 2019 19:47 - 21 minutes - 19.3 MB

Pink Sheet Regulatory Podcast Episode 8 by Informa

CPhI Pharma Awards 2019: How to Create a Winning Entry

July 11, 2019 08:41 - 6 minutes - 4.86 MB

Thinking of nominating yourself, a colleague, your company, or your team for an award this year but not sure where to start? We’ve prepared a podcast just for you with tips on putting together your entry as well as an overview of the CPhI Awards 2019.

Device Week, 8 July 2019: Omron Healthcare Update; New Watchman Data

July 05, 2019 16:18 - 8 minutes - 15.9 MB

In this edition of Device Week, Medtech Insight’s Marion Webb reviews her interview with Omron Healthcare CEO Ranndy Kellogg at the recent AdvaMed conference in San Francisco. Reed Miller discusses the latest cost-effectiveness study of Boston Scientific’s Watchman left-atrial appendage closure device. For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2FWqEWl Medtech Insight articles addressing topics discussed in this episode. Expert Panel Discus...

Device Week, 2 July 2019: What Are The Prospects For Medtech Innovation In A Post-Brexit UK?

July 01, 2019 12:59 - 13 minutes - 9.09 MB

It may often seem like Brexit is the only story in town in the UK, but within health care and medtech, a lot of system transformation and future planning for access to medtech innovation is underway, as this Medtech Insight podcast with Ashley Yeo and Amanda Maxwell underlines.

Pink Sheet Regulatory Podcast Episode 7

June 27, 2019 21:34 - 23 minutes - 16.3 MB

Pink Sheet Regulatory Podcast Episode 7 by Informa

Pink Sheet Regulatory Podcast Episode 6

June 20, 2019 21:34 - 22 minutes - 15.2 MB

Pink Sheet Regulatory Podcast Episode 6 by Informa

Device Week, 20 June, 2019 – ADA 2019 Key Players,Trial Results From Kinetics And Myriad Genetics

June 20, 2019 19:26 - 13 minutes - 24.5 MB

In this edition of Device Week, Medtech Insight's Catherine Longworth chats with Marion Webb about her upcoming Market Intelligence story based on interviews with the biggest players in the diabetes market at the recent annual American Diabetes Association meeting. Reed Miller discusses Global Kinetics' recent data on its Personal KinetiGraph that can help identify Parkinson's patients most likely to benefit from device-assisted therapy and Myriad Genetics' POLO trial results. Listen to th...

Device Week, 14 June 2019: Genomic Spy Games?

June 14, 2019 17:27 - 8 minutes - 15.7 MB

In this week's Medtech Insight podcast, executive editor Shawn M. Schmitt and senior reporter Sue Darcey discuss recent reporting on efforts by US senators to control and stop Chinese researchers in the US from using their research jobs at the National Institutes of Health, and at American medical colleges and universities, to steal genomic data and share it with the Chinese government. Medtech Insight articles addressing topics discussed in this episode: • US Senators Ask HHS IG To Investiga...

Pink Sheet Regulatory Podcast Episode 5

June 11, 2019 16:44 - 21 minutes - 15 MB

Pink Sheet Regulatory Podcast Episode 5 by Informa

Device Week: AdvaMed Medtech in San Francisco & Inhalation & Respiratory Drug Delivery Summit in NYC

June 07, 2019 19:38 - 10 minutes - 18.4 MB

In this edition of Device Week, Medtech Insight's Marion Webb discusses the AdvaMed MedTech Conference in San Francisco which focused on digital health devices and senior reporter Catherine Longworth discusses the Inhalation & Respiratory Drug Delivery device meeting held in New York City.

Pink Sheet Regulatory Podcast Episode 4

June 05, 2019 21:57 - 21 minutes - 12.7 MB

Pink Sheet Regulatory Podcast Episode 4 by Informa

Scrip Awards - Why Enter

May 24, 2019 09:32 - 6 minutes - 9.37 MB

Find out more about how to write your entry to submit to the awards.

Pink Sheet Regulatory Podcast Episode 2

May 23, 2019 22:03 - 15 minutes - 7.87 MB

Pink Sheet Regulatory Podcast Episode 2 by Informa

Global Generics & Biosimilars Awards 2019 - Why Enter

May 22, 2019 14:33 - 5 minutes - 8.71 MB

Find out more about how to write your entry to submit to the awards.

Device Week, 22 May 2019 –Former Verb Surgical CEO Talks About Digital Surgery, Encourages Think Big

May 21, 2019 22:57 - 6 minutes - 11.6 MB

In this edition of Device Week, Medtech Insight's Catherine Longworth reports on her experience at the BIOMEDevice meeting in Boston, where she talked to CEO Scot Huennekens, the former CEO of Verb Surgical, the robotics start up formed by Google and Johnson & Johnson’s Ethicon. Verb is combining robotics, advanced instrumentation, advanced visualization, data analytics and machine learning to create a platform for digital surgery, rather than trying to compete with the existing surgery robot...

Device Week, 17 May 2019 – Gottlieb Talks Reimbursement; DeLauro Reintroduces Safety Act

May 17, 2019 21:45 - 8 minutes - 16.1 MB

In this week's Medtech Insight podcast, Danny Al-Faruque discusses a recent speech by former FDA head Scott Gottlieb at the National Press Club in Washington, DC, that focused on product reimbursement issues. And Sue Darcey talks about a new push by US Rep. Rosa DeLauro to remove PMA-product liability suit protections for devices, with her reintroduction of the Medical Device Safety Act. Medtech Insight articles addressing topics discussed in this episode: • From Regulation To Reimbursement: ...

Pink Sheet Regulatory Podcast

May 17, 2019 13:29

Pink Sheet Regulatory Podcast by Informa

Pink Sheet Regulatory Podcast

May 17, 2019 13:29 - 20 minutes - 25.9 MB

Pink Sheet Regulatory Podcast by Informa

MedTech Insight Awards: Why enter?

May 15, 2019 10:18 - 6 minutes - 4.57 MB

Find out more about how to write your entry to submit to the awards.

Device Week, 10 May, 2019 – Global Arthroscopy Products Market, Biotronik Starts First ICD Study

May 10, 2019 00:24 - 6 minutes - 11.3 MB

In this edition of Device Week, Medtech Insight's Reed Miller chats with Marion Webb about her upcoming Market Intelligence story covering the global arthroscopy and sports medicine products market, based on Informa's new Meddevicetracker report, with a focus on the fast-growing hip arthroscopy market. Reed Miller discusses Biotronik's new BIO-LIBRA study designed to measure sex-specific outcomes in patients with non-ischemic cardiomyopathy treated with implantable cardioverter defibrillators...

Device Week, April 30, 2019 – What’s At Stake For ‘Medicare For All’ And Medtech

April 30, 2019 21:07 - 7 minutes - 13.1 MB

In this week's Medtech Insight podcast, Sue Darcey and Shawn M. Schmitt discuss what a rash of new “Medicare for All” bills being explored by the US Congress and several 2020 Democratic presidential hopefuls could mean for the medtech and diagnostics industry. Medtech Insight articles addressing topics discussed in this episode: • Medtech CEOs Like Stryker's Lobo 'Scared' Of 'Medicare For All' Driving Lower Device Prices, Former CMS Chief Says

Device Week, April 26, 2019 – Paragonix Launches Cardiac Organ Transport Device

April 26, 2019 20:22 - 7 minutes - 13.6 MB

In this edition of Device Week, Medtech Insight's Reed Miller chats with Marion Webb about her Start-Up Spotlight feature on Paragonix Technologies, which hopes to replace conventional organ transportation with its newly launched SherpaPak system. Reed Miller discusses the impact of Boston Scientific's entry into the US TAVR market after the US FDA approved its Lotus Edge TAVR system. Listen to the podcast via the player below: For more information on Medtech Insight and to start a free ...

Philips CEO On Future Of AI

April 18, 2019 21:00 - 24 minutes - 18.9 MB

Frans van Houten, CEO of Philips, talked about the future of AI and what his company is doing to be a part of it. He spoke with Medtech Insight at the World Medical Innovation Forum.

Device Week, April 17, 2019 – Safety Under Spotlight

April 17, 2019 20:00 - 7 minutes - 13.2 MB

In this week's Medtech Insight podcast, Shawn M. Schmitt explains why the FDA ordered transvaginal mesh products removed from the US market, and Ferdous Al-Faruque highlights a growing device-shortage issue linked to problems at two US sterilization facilities. Medtech Insight articles addressing topics discussed in this episode: • FDA Yanks Transvaginal Mesh From US Market; Boston Sci 'Surprised'; Firms Have 10 Days To Submit Withdraw Plan • There's A Pediatric Air-Tube Shortage Because A S...

FDA’s Bakul Patel Talks Pre-Cert, AI Guidance

April 10, 2019 21:32 - 11 minutes - 9.67 MB

The associate director for digital health talked with Medtech Insight at the World Medical Innovation Forum about international interest in the agency’s precertification pilot program and what is needed to get a new draft guidance on artificial intelligence. Tags: bakul patel, medical devices, artificial intelligence, pre-cert, digital health, AI, guidance, FDA, world medical innovation forum, WMIF19

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