Citeline Podcasts
1,366 episodes - English - Latest episode: 3 days ago - ★★★★★ - 24 ratingsCiteline 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.
Homepage Apple Podcasts Google Podcasts Overcast Castro Pocket Casts RSS feed
Episodes
Device Week Podcast - Episode 99
June 23, 2017 18:11 - 15.9 MBOn this week's Medtech Insight podcast: US congressional hearing highlights India’s efforts to place price caps on foreign-made devices; Senate health-care bill nixes device tax; Costa Rican quality control experts lean on each other for industry education; US FDA issues a draft guidance on electronic records and signatures.
Device Week Podcast – Episode 98
June 16, 2017 19:37 - 18 MBOn this week's Medtech Insight podcast: expect digital health guidance documents from US FDA soon, the agency’s commissioner says; FDA optimistic it will push out a final version of a 3D printing manufacturing guidance this year; US government releases data on the number of people who would lose health insurance under the American Health Care Act; Wells Fargo report fingers which device types would be most impacted by Trumpcare; a look at FDA approval and clearance trends, including a noticea...
UK Medtech Upscales International Plans Ahead of Brexit
June 16, 2017 14:29 - 9.84 MBUK medtech industry’s plans to encourage more international business for home-grown companies.
Device Week Podcast - Episode 97
June 09, 2017 18:26 - 18.4 MBOn this week's Medtech Insight podcast: amendments targeting device accessories, medical imaging and post-market surveillance tacked onto FDA Reauthorization Act; a project funded by the US Department of Homeland Security aims to improve device cybersecurity; FDA moves to implement more 21st Century Cures legislation; the Sentinel Cerebral Protection System gains de novo clearance; a report from the MiXii Biomed Life Sciences and Technology Conference in Tel-Aviv.
Compliance 360° Part 9: US FDA Is Looking Closely At Process Validation – Are You Ready?
June 05, 2017 16:32 - 17 MBCompliance 360° Part 9: US FDA Is Looking Closely At Process Validation – Are You Ready? by Informa
Device Week Podcast - Episode 96
June 02, 2017 23:43 - 18.6 MBOn this week's podcast, Tina Tan discusses takeaways from the International Neuromodulation Society congress in Scotland, Reed Miller highlights the best evidence to date supporting patent foramen ovale closure as a treatment to prevent stroke, and Sue Darcey reports on Zika virus diagnostic discussion on Capitol Hill.
Rose Report Podcast - May 2017
June 01, 2017 20:08 - 16.2 MBThe Rose Sheet’s editorial team counts down the top five news items or issues in both the cosmetics and dietary supplement sectors over the past month, including cosmetics reform legislation and its potential bearing on FDA inspections, NGO attacks on sunscreens and developments that could be welcome to companies in terms of how class actions and other litigation are treated by federal courts.
How To Win A Scrip Award?
June 01, 2017 14:40 - 9.94 MBThe deadline for entries to the Scrip Awards is fast looming. In this podcast, Mike Ward speaks to Scrip Executive Editor Alex Shimmings, a chair of the Scrip Awards judging panel, about how best to enhance one’s chances to win one the Scrip Awards categories.
Device Week Podcast - Episode 95
May 26, 2017 16:51 - 11.4 MBOn this week's Medtech Insight podcast: US FDA Commissioner Scott Gottlieb defends his agency’s budget; AdvaMed’s new chair talks to Medtech Insight about challenges he faces and where he’s leading the industry group; a close look at mobile technology company Qualcomm Life; a two-part Medtech Insight series on pain management is highlighted.
Q&A: Yared Hits The Ground Running
May 22, 2017 20:46 - 54.8 MBIn an interview to discuss his initial experience as chairman of AdvaMed, Nadim Yared tells Medtech Insight his priority is repealing the medical device excise tax regardless of how such a repeal may affect enrollments in an ACA repeal. Also, while some in industry have expressed concern about the Trump administration's unpredictable nature, Yared says AdvaMed is suited to handle the shifting political winds.
NEST’s Fleurence On New Medical Device Project
May 19, 2017 20:05 - 15.4 MBThe National Evaluation System for health Technology is finally starting to get off the ground as Rachael Fleurence took the helm last month. In an interview with Medtech Insight the new executive director talks about her qualifications and hopes for the project over the next year and beyond.
Device Week Podcast - Episode 94
May 19, 2017 20:02 - 21.2 MBOn this week's Medtech Insight podcast: ex-US FDA Commissioner Bob Califf talks new commish and Trump; the latest on the Food and Drug Administration Reauthorization Act (FDARA); FDA recommends approval for the TransMedics Organ Care System; blood lead tests made by Magellan Diagnostics may give bad results; updates from the Heart Rhythm and EuroPCR meetings, held in Chicago and France, respectively.
Podcast: Califf Discusses Verily, Departure From FDA
May 17, 2017 20:48 - 28.7 MBFormer FDA Commissioner Robert Califf spoke to Medtech Insight about his new job working with Verily Life Sciences, formerly known as Google Life Sciences, where he hopes to help bridge the gap between technology and health care delivery. He also discussed his departure from FDA and said he hopes the new commissioner, Scott Gottlieb, will be able to push back on any unreasonable demands from President Trump.
Podcast: The Trump Factor – Current & Potential Changes For US Medtech
May 16, 2017 15:21 - 11.6 MBIn Vivo asks AdvaMed government affairs director JC Scott what the medical technology industry hopes for, expects, and fears from the new Republican president in the US.
The New World Of EU Regulation – MDR And IVDR: How To Prepare And Avoid The Hurdles
May 15, 2017 16:34 - 15.9 MBThis podcast give a timely update on the progress of the EU Medical Device and IVD Regulations, and addresses what will change for medtech companies wishing access the EU market in the future. The texts of the new Regulations were published on May 5 and enter into force on May 25. Medtech Insight's EU regulatory affairs expert Amanda Maxwell takes a stakeholder's eye view of how to prepare for the Regulations, which will apply after transition periods.
Device Week Podcast - Episode 93
May 12, 2017 19:06 - 28.5 MBOn this week's Medtech Insight podcast: Scott Gottlieb takes the reins at FDA; US agency ready to accept 510(k) devices into the Expedited Access Pathway; plans finally revealed for “program alignment,” which will change FDA’s approach to facility inspections; news from the BioTrinity 2017 conference; a look at the landscape of the soft tissue fixation device market.
Device Week Podcast - Episode 92
May 05, 2017 19:24 - 14.1 MBOn this week's podcast, Reed Miller discussed takeaways from the recent Design of Medical Devices conference, in Minnesota, including his Q&A with leaders of the Medical Device Innovation Consortium and new technologies presented. Also, a roundup of regulatory and policy news from the EU and US.
Rose Report Podcast - April 2017
May 03, 2017 00:12 - 22.3 MBThe Rose Sheet’s editorial team discusses key news and trending issues in the cosmetics and dietary supplement sectors over the past month, including the prospects for cosmetics regulatory reform legislation, “natural” litigation, notable National Advertising Division cases, “healthy” labeling and CVS’ planned quality standards for dietary supplement products.
Device Week Podcast - Episode 91
April 28, 2017 17:59 - 21.2 MBOn this week's Medtech Insight podcast: four companies highlighted at a London event showcasing new health-care technology and medical device start-ups; US FDA's device center looks to build a quality system and plans to shuffle staff under a "Total Product Life Cycle" initiative; the latest on legislative efforts around the classification of device accessories; BD acquires CR Bard for $24bn; a spotlight on the growth of the diabetes management devices market; and more.
The 100 Day Test: Post-Inauguration Insights And Policy Changes Under The New Trump Administration
April 27, 2017 17:43 - 24.1 MBA podcast of a presentation made to Informa's Platinum Partners Group in Boston on April 5.
Podcast: Supreme Court Oral Arguments In Amgen vs. Sandoz Biosimilars Case
April 24, 2017 16:03 - 11.3 MBPink Sheet reporter Brenda Sandburg offers her analysis and insight into oral arguments at the Supreme Court in the Amgen vs. Sandoz biosimilars case April 26. In a podcast interview with Prevision Policy’s Kate Rawson, Sandburg outlines the legal issues to be resolved in Amgen vs. Sandoz, the specific questions she’ll be listening for during oral arguments, and what to expect from the newest addition to the Supreme Court: Justice Neil Gorsuch.
Device Week Podcast - Episode 90
April 21, 2017 17:12 - 8.43 MBOn this week's Medtech Insight podcast we highlight two big M&A deals: Abbott & Alere, and Medtronic & Cardinal Health.
Device Week Podcast - Episode 89
April 14, 2017 18:23 - 20.9 MBOn this week's Medtech Insight podcast: cybersecurity and US FDA warning letter headaches for St. Jude; a conversation with AdvaMed CEO Scott Whitaker; a profile of device-maker InVivo Therapeutics, which is looking to leverage 2tst Century Cures provisions; a verdict was reached in a Kimberly-Clark fraud suit; comments roll in on the Diagnostic Accuracy and Innovation Act in the US; and more.
New Center For Artificial Intelligence To Offer Quality, Regulatory Solutions
April 13, 2017 15:49 - 14.9 MBIn this Medtech Insight podcast, Xavier University's Marla Philips explains why the school is teaming up with IBM Watson Health to launch a Center for Artificial Intelligence. "Our mission is to provide artificial intelligence solutions. We will have free and open access for anyone to use so they can implement those solutions across the pharma and device industries, and FDA itself," she says.
Oncology Center of Excellence Open For Business: Podcast With US FDA’s Richard Pazdur
April 11, 2017 15:40 - 33.4 MBThree months after the official launch of the Oncology Center for Excellence, applications for cancer products are now being reviewed by OCE medical teams. OCE Director Richard Pazdur provides more details on the process and procedures of the newly established center in a podcast interview.
Conversation with Washington Strategist Chris Krueger
April 07, 2017 19:27 - 33.2 MBCowen & Co.'s Washington Strategist Chris Krueger and Prevision Policy's Ramsey Baghdadi talk about the initial strategy behind the House AHCA bill, whether it will be revisited, the impact on user fee legislation and whether there is room for drug pricing in the upcoming legislative period.
Device Week Podcast - Episode 88
April 07, 2017 17:55 - 15.1 MBOn this week's podcast, we checked in on Q1 2017 trends that we have spotted in Medtech Insight's online data trackers for venture funding, M&A and global product approvals.
Rose Report Podcast – March 2017
April 07, 2017 15:40 - 13 MBThe Rose Sheet’s editorial team discusses key news and developments over the past month, including cosmetics industry stakeholders’ efforts to tack cosmetics reform provisions onto pending US user-fee reauthorization legislation, continued tension in the EU regarding animal-testing policy under the Cosmetics Regulation and REACH, and dietary supplement firms’ ongoing struggle to comply with Good Manufacturing Practices requirements to FDA’s satisfaction.
Device Week Podcast - Episode 87
March 31, 2017 20:32 - 27.2 MBOn this week's podcast, we discuss the bad data news that has come in recent weeks for Abbott Labs' Absorb BVS bioresorbable scaffold; the latest user-fee reauthorization hearing on Capitol Hill; our recent interview with outgoing AdvaMed chair Vince Forlenza; and recent deep-dives into compliance and IP challenges facing the digital medtech space.
Accelerating Antibiotics: Kevin Outterson and Joe Larsen on CARB-X
March 30, 2017 19:22 - 42.2 MBCARB-X Executive Director Kevin Outterson and BARDA Acting Deputy Director Joe Larsen describe the work of the accelerator, which announced the first eleven projects in its Powered by CARB-X portfolio March 30. The Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, announced the first eleven projects in its Powered by CARB-X portfolio March 30. Details on each of the initial projects are here: http://www.carb-x.org/portfolio; they include three...
Forlenza To Yared: Repealing Medical Device Tax Still No. 1 Priority
March 29, 2017 19:53 - 27.2 MBVince Forlenza, recently retired chair of AdvaMed's board, says for the most part the issues facing the new chair and the medical device lobby group in general are the same: repealing the 2.3 percent medical device excise tax and passing the device user fee reauthorization.
Compliance 360° Part 8: Patient Influence On US FDA’s Enforcement Strategy
March 27, 2017 14:03 - 16.6 MBThis is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this eighth and final installment, former US FDA investigations branch director Ricki Chase explains how the role of the patient influences FDA's enforcement strategy.
Device Week Podcast - Episode 86
March 24, 2017 20:08 - 29.3 MBOn this week's Medtech Insight podcast: the latest on efforts to repeal and replace the Affordable Care Act; reauthorization of MDUFA IV coming along; user fees for device reviews proposed by Trump administration; device firms advised to keep an eye on pricing policies in China; new R&D developments; orthopedic companies gather at the American Academy of Orthopedic Surgeons annual conference; and more.
Compliance 360° Part 7: Factors Feeding Your Inspection Cycle – A New Paradigm
March 20, 2017 18:14 - 23.9 MBThis is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this seventh installment, former US FDA investigations branch director Ricki Chase explains how new initiatives within the agency and center for devices may affect your facility inspections.
Device Week Podcast - Episode 85
March 17, 2017 17:49 - 23.9 MBOn this week's Medtech Insight podcast: President Trump releases budget "blueprint" calling for cuts in many US agencies, including FDA; class II designations formalized by FDA for a slew of important products; FDA proposes exempting from 510(k) requirements hundreds of class II devices; a new surgical robotic project wins a €4m grant from European Commission; an update from the American College of Cardiology annual scientific sessions.
FDA Commissioner Gottlieb: Establishment Pick, Strong Policy Background
March 13, 2017 19:53 - 27.3 MBCole Werble and Ramsey Baghdad discuss their initial impressions of Scott Gottlieb as President Trump's choice to lead FDA, his unique policy experience, what it means from the drug industry, "Council of Elders" drug approvals, and how it impacts the user fee negotiations.
Compliance 360° Part 6: Don’t Do That! How To Respond To FDA-483s
March 13, 2017 19:14 - 25.7 MBThis is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this sixth installment, former FDA investigations branch director Ricki Chase explains how your firm can best respond to the agency following the issuance of an FDA-483 inspection form.
Device Week Podcast - Episode 84
March 10, 2017 22:30 - 14.7 MBOn this week's podcast, we discussed a modification to FDA's definition of "intended use," legal patent issues with Boston Scientific’s Lotus valve, the Republican bill to replace the Affordable Care Act and some disappointing clinical trial news that was presented at the annual Society of Interventional Radiology conference.
A Conversation with FDA's Janet Woodcock
March 06, 2017 17:29 - 26.8 MBCenter for Drug Evaluation & Research Director Janet Woodcock discusses her new role as interim director in the Office of New Drugs (OND) following the departure of John Jenkins, an update on the Office of Pharmaceutical Quality (OPQ), accelerating new drug approvals, and orphan drug development.
Compliance 360° Part 5: Medical Device 483s – US FDA's Top 5 Observations
March 06, 2017 01:11 - 25.5 MBThis is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this fifth installment, former FDA investigations branch director Ricki Chase highlights the agency's top 5 inspection observations found on FDA-483 inspection forms.
Device Week Podcast - Episode 83
March 03, 2017 19:09 - 16.2 MBPan-cancer screening test developer Grail bags more than $1bn in funding; Trump bashes US FDA; fight likely in Senate over Seema Verma's appointment to head CMS; "FDA Precheck" floated by agency; a deep-dive look into the surgical robot market.
Compliance 360° Part 4: How To Better Manage Your Quality Data
February 27, 2017 15:58 - 16.5 MBThis is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this fourth installment, former FDA investigations branch director Ricki Chase explains how your firm can better manage your quality data.
Podcast: Brexit – Next Steps For The UK Medtech Industry.
February 27, 2017 13:03 - 12.6 MBBrexit will dominate the thoughts, behavior and business of medical technology companies in the UK for many years to come. The hard work for the UK govt is yet to come, given the EU withdrawal talks and the trading relationship negotiations that the UK has yet to embark on with the EU. The local industry is stressing any positives, including development of the govt’s new Life Sciences Strategy, part of the overall UK Industrial Strategy. This should offer manufacturers much support. In thi...
Podcast: Attorney Discusses Cybersecurity Whistleblower Protections in Medtech
February 24, 2017 21:14 - 27.9 MBAttorney Alexis Ronickher speaks with Medtech Insight about what protections cybersecurity whistleblowers may have in the medical device industry.
Device Week Podcast - Episode 82
February 24, 2017 18:45 - 20.1 MBOn this week's Medtech Insight podcast: the response by a US FDA advisory panel to Claret Medical's de novo submission for the first brain-filter device intended to protect patients undergoing transcatheter aortic heart valve replacement; a reporting trip to the Israeli innovation hub; a Boston Scientific recall; and bariatric surgery data.
Compliance 360 Part 3: Building Trust With US FDA – Can It Be Done?
February 20, 2017 15:58 - 14.1 MBThis is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this third installment, former FDA investigations branch director Ricki Chase explains how your firm can build trust with agency investigators during a facility inspection.
Device Week Podcast - Episode 81
February 17, 2017 20:31 - 15.7 MBOn this week's Medtech Insight podcast: US House Ways and Means Committee sets out plans for the next two years, including a review of all taxes and fees connected to the Affordable Care Act; Allergan and Hologic enter into separate big-money acquisitions in the aesthetics devices arena; a deep-dive look at the osteoporosis diagnostics market.
Compliance 360 Part 2: Getting The Most Out Of Inspection Close-Out Meetings
February 13, 2017 14:08 - 19.8 MBCompliance 360 Part 2: Getting The Most Out Of Inspection Close-Out Meetings by Informa
Device Week Podcast - Episode 80
February 10, 2017 18:19 - 15 MBOn this week's Medtech Insight podcast: congressional efforts to permanently repeal the medical device tax; a coordinated registry network for stroke devices; a GAO report on US FDA's Medical Device Reporting system related to power morcellators; January’s FDA approval trends.
Podcast: Mark McClellan on the Launch of the Duke-Margolis Center for Health Policy
February 10, 2017 16:41 - 14.8 MBDuke-Margolis Center for Health Policy Director Mark McClellan talks about the February 9 launch of the center, work on value-based payments, and thoughts on “smarter regulation” and the FDA commissioner job.