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.
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Episodes
Device Week, April 10, 2019 - Alcon Is Finally Free From Novartis; EOS Promotes 3D Ortho-Imaging
April 10, 2019 19:40 - 6 minutes - 12.8 MBIn this edition of Device Week, Catherine Longworth reports on eye-care giant Alcon's $28bn spin-off from Novartis. Marion Webb reviews her interview with executives from EOS imaging SA, a developer of imaging medical devices for orthopedics. Medtech Insight articles addressing topics discussed in this episode: All 'Bye' Itself: Alcon Spins Out From Novartis In $25Bn Stock Listing https://bit.ly/2G4qLhX Adios To Alcon In April As Novartis Confirms Spin-Off Date https://bit.ly/2Z1xbXA The ...
Device Week, April 5, 2019 – A Trio Of FDA Guidance Docs To Keep An Eye On
April 05, 2019 16:54 - 8 minutes - 16.3 MBIn this week’s podcast, Medtech Insight journalists Shawn M. Schmitt, Ferdous Al-Faruque and Elizabeth Orr discuss a recent flurry of guidance document news from US FDA on facility inspections, artificial intelligence and anthrax detection devices. Medtech Insight articles addressing topics discussed in this episode: • With Fresh Guidance, US FDA Aims For Consistency In Device Facility Inspections (https://protect-us.mimecast.com/s/fbN6CQWNOwhkRVZoLsPtuEU?domain=medtech.pharmaintelligence.inf...
Device Week, March 29, 2019 –UK Oxfordshire Wants To Become Digital-Health Hub,Trials and Innovation
March 29, 2019 21:20 - 9 minutes - 17.3 MBIn this week's podcast, Medtech Insight's Catherine Longworth discusses UK Oxfordshire's plans to create a regional 'digital-health' hub. And Marion Webb talks about meeting with leaders from Zimmer Biomet and DePuy Synthes to discuss robotic systems and other solutions presented at the recent American Academy of Orthopedics Surgeons' conference in Las Vegas. Listen to the podcast via the player below: For more information on Medtech Insight and to start a free trial, click here: http://...
Innovations in Market Access: High-Impact Practices for a New Era of Transformational Medicine
March 27, 2019 13:47 - 23 minutes - 16.2 MBIn Vivo discusses ways to enhance the visibility of the market access function in biopharma with two leaders of a 20-company initiative to promote best practices in the field: Indranil Bagchi, Senior Vice-President, Global Value and Access, Novartis Oncology; and Srikant Vaidyanathan, Senior Partner and Managing Director, the Boston Consulting Group.
FDA Commissioner Discusses Hopes For LDT Legislation
March 22, 2019 20:40 - 3 minutes - 3.44 MBFDA Commissioner Scott Gottlieb spoke at the Brookings Institution March 20 to talk about his departure from the agency. He noted that among the top issues that he hopes will be addressed after he leaves on April 5, are legislation addressing over-the-counter drugs and laboratory developed tests under a in-vitro clinical test bill known as the VALID Act.
Device Week, March 22, 2019 – Goings-On At US FDA
March 22, 2019 18:03 - 8 minutes - 16.5 MBIn this week’s podcast, senior reporters Elizabeth Orr and Ferdous Al-Faruque give a quick rundown of FDA goings-on the device industry should keep a sharp eye on, including a reorganization of the Center for Devices and Radiological Health, remarks from outgoing agency head Scott Gottlieb on laboratory developed tests, and news from a recent FDA neurological devices advisory panel meeting. Medtech Insight articles addressing topics discussed in this episode: • FDA Device Center Reorg Set To ...
MDMA’s Leahey: A Year In Review
March 14, 2019 21:29 - 20 minutes - 25 MBOne of the top US medical device lobbyists spoke to Medtech Insight about their work to extend a moratorium on the medical device excise tax and getting reimbursement for medical devices sooner. He commended FDA Commissioner Scott Gottlieb and their work to implement provisions in MDUFA IV.
Device Week, March 14, 2019 – Smith & Nephew Buys Osiris To Boost Wound Care Business
March 14, 2019 18:48 - 9 minutes - 18 MBIn this edition of Device Week, Medtech Insight’s Catherine Longworth discusses Smith & Nephew’s $660m acquisition of regenerative medicine company Osiris Therapeutics and Reed Miller talks about the clinical trial highlights from the recent CRT Meeting in Washington and looks forward to the American College of Cardiology conference next week. For more information on Medtech Insight and to start a free trial, click here. https://pharmaintelligence.informa.com/products-and-services/news-and-i...
Device Week, March 7, 2019 – Scott Gottlieb Resigns
March 07, 2019 22:02 - 14 minutes - 26.5 MBOn the latest Medtech Insight podcast, David Filmore and Ferdous Al-Faruque discuss the unexpected news that Scott Gottlieb is leaving US FDA next month. What has been his legacy for medtech, and who will replace him? 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: •Scott Gottlieb Calls It Quits After An Active Tenure At US FDA: https://bit.ly/2SRlQVM •Gottlieb Wants Hi...
A Chat With Immuno-oncology Trailblazer Exec Dan Chen
March 05, 2019 17:17 - 25 minutes - 29.1 MBIn the last decade, anti-PD-1/L1 checkpoint inhibitors have been revolutionary in oncology, but while the impact has been dramatic, many patients still do not respond. Dan Chen, M.D., Ph.D., former global head of the cancer immunotherapy franchise at oncology leader Roche/Genentech, talks to Scrip and Pink Sheet journalist Emily Hayes about the cancer immunity cycle, lessons learned from trials of combinations of drugs and more. Recorded onsite at the ASCO-SITC Clinical Immuno-Oncology Sympos...
Device Week, Feb. 28,2019–BreastCancerImaging,TrialsPresentedAtAmericanCollegeofCardiologyConference
February 28, 2019 22:48 - 6 minutes - 12.5 MBIn this edition of Device Week, Medtech Insight's Reed Miller chats with Marion Webb about her upcoming Market Intelligence story on the global breast cancer imaging and biopsy market with Reed Miller highlighting late-breaking trials that will be presented at the upcoming American College of Cardiology Conference in New Orleans. 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 Insig...
Device Week, Feb. 22, 2019 – The Latest On Lab Reimbursement And Possible LDT Regulatory Reform
February 22, 2019 22:19 - 10 minutes - 19.7 MBIn this week’s podcast, senior reporter Sue Darcey talks about troubling developments for US laboratories and diagnostic test-makers that say the Government Accountability Office was mistaken in conclusions it reached in a recent report about how much labs will be billing Medicare for clinical tests. Also discussed are comments lab associations sent to US legislators, who have been trying to win industry and stakeholder consensus on a regulatory reform proposal for laboratory developed tests ...
Medtech Pressure Points And Opportunities In 2019 – The Global View From ZS
February 21, 2019 10:55 - 19 minutes - 13 MBBrian Chapman of consulting firm ZS talks to In Vivo in this podcast about the big challenges and the climate of change for medtechs in 2019
Harness Dickey’s Cauble Talks Patent Eligibility
February 19, 2019 22:24 - 13 minutes - 11.1 MBSeveral 2018 cases and a new USPTO guideline have added to the patent-eligibility discourse. Harness Dickey’s Chris Cauble talked to Medtech Insight about what patent-seekers need to know and do to win their patents.
Device Week, February 13, 2019 – Femtech Draws Investment;Smith & Nephew/Nuvasive Merger Rumors
February 13, 2019 21:15 - 5 minutes - 10.8 MBIn this edition of Device Week, Medtech Insight’s Reed Miller talks to managing editor Marion Webb about the growing interest among investors in "femtech," technology that specifically addresses women's health issues that have been frequently overlooked in the past. And London-based reporter Catherine Longworth addresses the recent media reports that Smith & Nephew may make a bid for spine-device company Nuvasive. For more information on Medtech Insight and to start a free trial, click here...
Device Week, Feb. 5, 2019 – What’s New, MDSAP?
February 05, 2019 21:34 - 11 minutes - 20.8 MBThe burgeoning Medical Device Single Audit Program is the focus of this week’s podcast. Deputy editor Shawn M. Schmitt talks about the latest news on MDSAP and shares some tips for acing an MDSAP audit. Medtech Insight articles addressing topics discussed in this episode: • Canada's Switch From CMDCAS To MDSAP Went Off Without A Hitch – Despite 403 Firms Leaving The Market • MDSAP Is A Snap If Your Firm Follows Quality Systems Standard ISO 13485, Auditor Says • Compliance Corner: MDSAP Audito...
Device Week, Jan. 31, 2019 - Livongo's Acquisition Of myStrength, FDA Evaluates Paclitaxel Devices
January 31, 2019 23:53 - 9 minutes - 17.1 MBIn this edition of Device Week, Medtech Insight's Catherine Longworth chats with Marion Webb about Livongo's acquisition of behavioral health company myStrength and with Reed Miller about the controversy surrounding the meta-analysis finding of a higher mortality risk with paclitaxel-eluting peripheral devices. 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 addres...
Device Week, Jan. 25, 2019 – Expert Tips And Advice For Makers Of Combination Products
January 25, 2019 20:40 - 11 minutes - 21.2 MBOn this week’s podcast, deputy editor Shawn M. Schmitt gives a roundup of recent Compliance Corner and Medtech Tips reports that featured combination drug-device product advice from quality experts at Eli Lilly and Johnson & Johnson. Medtech Insight articles addressing topics discussed in this episode: • Medtech Tips: Should A Combo Product-Maker's Quality System Be Device- Or Drug-Led? J&J, Eli Lilly Experts Weigh In https://medtech.pharmaintelligence.informa.com/MT124525/Medtech-Tips-Should...
Device Week,Jan. 18, 2019 - Smith&Nephew's Growth Plans, M&A Activity;JP Morgan Healthcare Conf
January 18, 2019 22:28 - 7 minutes - 14.2 MBIn this edition of Device Week, Medtech Insight's Catherine Longworth chats with Marion Webb about some key takeaways at this year's JP Morgan Healthcare conference. That includes a Q&A with Smith & Nephew's new CEO, Namal Nawana on his growth strategy for the British medtech giant, new partnership announcements between medtech and tech companies, and trends in digital health. Listen to the podcast via the player below: For more information on Medtech Insight and to start a free trial, cl...
Device Week, Jan. 11, 2019 – A New Plan From NHS In A Period Of UK Uncertainty
January 11, 2019 19:33 - 12 minutes - 22.4 MBOn this week's podcast, Ashley Yeo talks about a the "Long Term Plan" for the UK's health-care system published by the country's NHS this week, and the implications of Brexit. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR. Medtech Insight articles addressing topics discussed in this episode: NHS' New Plan: 'Long-Termism' Is Also Needed In Adoption And Spread Of Technology In UK: https://bit.ly/2D61q6T ABHI 30: NHS Long-Term Plan Promises Dia...
Device Week, Jan. 4, 2019 – Reviewing A Record Year For M&A In Medtech
January 04, 2019 19:06 - 5 minutes - 9.22 MBIn this edition of Device Week, Medtech Insight’s Catherine Longworth reviews the year in mergers and acquisitions – including big moves by Medtronic, Stryker, and Boston Scientific. Looking forward to 2019, companies will be looking for acquisitions to help them take advantage of the emergence of Asia as the second-biggest device market, respond to Brexit, and potentially cope with new device regulations around the world. For more information on Medtech Insight and to start a free trial, cl...
Device Week, Dec. 21, 2018 – Looking Back At The Year’s Top Legal Issues
December 21, 2018 20:26 - 13 minutes - 25.5 MBOn this week’s podcast, senior reporter Elizabeth Orr gives a recap on the year in US legal news and how the courts impacted the medical device industry, from new Supreme Court justices Neil Gorsuch and Brett Kavanaugh to multimillion-dollar settlements in device safety cases – and much more.
Medtech Insight Recaps 2018 FDA/CMS Summit
December 17, 2018 21:29 - 20 minutes - 38.3 MBSenior Medtech Insight Reporter Ferdous Al-Faruque talked about some of the discussions that took place at the summit and what they mean for industry. He opines what we can expect to see in 2019 and what industry should keep an eye on.
Device Week, Dec. 14, 2018 – Physicians Offer Perspective On Diabetes Apps
December 13, 2018 17:52 - 8 minutes - 14.8 MBResearchers Apply Cancer Radiation To Cardiac Arrhythmia In this edition of Device Week, Medtech Insight’s weekly podcast, managing editor Marion Webb gives an overview of physicians’ perspective of digital apps for diabetes patients and Deputy Editor Reed Miller discusses the early research into a potentially promising non-invasive radiation technique for treating ventricular tachycardia. For more information on Medtech Insight and to start a free trial, click here. Medtech Insight articl...
Device Week, Dec. 7, 2018 – FDA Cardiac Panel Meets
December 07, 2018 19:58 - 11 minutes - 21.3 MBOn this week's podcast, David Filmore talks to Elizabeth Orr and Reed Miller on the outcomes of this week's FDA Circulatory System Devices Panel, where agency advisors addressed a "Breakthrough" heart failure device and the data needs for hypertension devices. Listen to the podcast via the player below: Articles addressing topics discussed in this podcast: FDA Device Panel Delivers Thumbs Up For Breakthrough Heart-Failure Device https://bit.ly/2E7YwzC Work With Patients To Design Trials F...
CARE Awards 2019 - Why Enter
December 07, 2018 12:45 - 13 minutes - 6.37 MBThe CARE Awards 2019 is your opportunity to be recognized in the company of other luminaries in the industry for your outstanding contributions toward improving the quality of life for present and future generations around the globe. Don’t wait – submit your 2019 CARE Awards nomination today!
Device Week, Nov. 29, 2018 – Bioprinting Is Moving From Far-Fetched To Reality
November 29, 2018 18:59 - 7 minutes - 14 MBIn this edition of Device Week, Medtech Insight managing editor Marion Webb discusses the ongoing research that could lead to 3D-printing of human replacement organs and Catherine Longworth highlights the developments in “femtech,” medical technology primarily or exclusively for female patients. Articles addressing topics discussed in this episode: Market Intel: Cornea, Bio-Drugs, Artificial Hips On Track For 3D Printing https://bit.ly/2DB85a1 International Women's Day: Medtech's Women Mov...
Compliance 360° Part 14: Leverage FDA Data To Stay In The Agency's Good Graces
November 27, 2018 21:30 - 18 minutes - 33.9 MBThis is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this fourteenth installment, former FDA investigations branch director Ricki Chase explains how device-makers can leverage publicly available data from the agency to determine where they might fall short when it comes to complying with FDA rules and regulations.
AdvaMed’s Scott Whitaker And Greg Crist Discuss Upcoming ICIJ Investigation
November 21, 2018 16:41 - 41 minutes - 76.2 MBThe device industry is bracing for of an in-depth, global investigation of the sector that is anticipated from an international consortium of journalists. AdvaMed’s top officials talk about their concerns with the project and plans to respond.
Device Week, Nov. 23, 2018 – US FDA Patient Engagement, Safety Surveillance
November 21, 2018 12:07 - 9 minutes - 16.6 MBOn this week's podcast, Elizabeth Orr and David Filmore discuss FDA's recent Patient Engagement Advisory Committee and a recent announcement from the agency about post-market surveillance updates and investments. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR. Medtech Insight articles referenced in this podcast: FDA Wrestles With Social Media At Patient Engagement Meeting: https://bit.ly/2FLJIJt https://medtech.pharmaintelligence.informa.com/ar...
Device Week, Nov. 14, 2018 – Digital Solutions Of The Future And Clinical Trial News and Insights
November 14, 2018 22:32 - 10 minutes - 19.3 MBOn this week’s podcast, Reed Miller talks to Medtech Insight’s managing editor Marion Webb about digital health technologies of the future, showcased at the Exponential Medicine conference in San Diego, featured in depth in the latest Market Intelligence story. Medtech Insight’s deputy editor Reed Miller introduces Medtech Insight’s new “Tracking Trials” section, which features a list of trials that are starting, ending or finishing enrollment; including the “Results Recap,” a summary of tria...
Device Week, Nov. 9, 2018 – What The US Midterms Mean For Medtech
November 09, 2018 17:52 - 8 minutes - 15.6 MBOn this week's podcast, David Filmore and Ferdous Al-Faruque discuss the results of this week's midterm elections in the US and what it could mean for the medtech sector. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR. Medtech Insight articles referenced in this podcast: 3 Big Medtech Takeaways From US Midterms https://bit.ly/2PhO6UL US Midterms: Industry Loses Some Supporters In Congress, But Retains Many https://bit.ly/2SU86eb
OTC Marketing Awards Podcast
November 06, 2018 16:52 - 5 minutes - 2.44 MBHave you submitted your nomination to the 24th Annual OTC Marketing Awards yet? This spectacular evening honouring the achievements of those making important contributions to the British OTC industry is coming soon, and you can be a part of the excitement. Learn more about how you can nominate your campaigns, brand or organisation for one or more of these unique awards that focus exclusively and entirely on suppliers of OTC products – non-prescription medicines, food supplements, and selecte...
Device Week,Nov. 2, 2018 – Third-Quarter Earnings Report Update From IVD,Cardio, and Ortho Companies
November 02, 2018 17:23 - 7 minutes - 14 MBOn this week's podcast, Reed Miller and Catherine Longworth give an overview of the third-quarter earnings reports from the major public companies in the IVD, cardiovascular, and orthopedics device sectors. Medtech Insight articles addressing topics discussed in the is episode: Focus More On Patients, Less On Hospitals, Experts Tell Device Companies Stryker Strikes Again, Buys HyperBranch Medical Technology TAVR Update: Edwards Delays European Launch Of Sapien 3 Ultra; New Medtronic CoreV...
Device Week, Oct. 26, 2018 – New Opioids Law, And 510(k) Pilot
October 26, 2018 19:14 - 9 minutes - 17.1 MBOn this week's podcasts, David Filmore talks to Sue Darcey about the opioids bill enacted in the US this week, including an expansion of "sunshine" payment reporting requirements for device-makers. And Elizabeth Orr discusses some recently launched 510(k)-process pilot programs and questions industry has about them. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR. Medtech Insight articles on topics addressed in this episode: President Signs Op...
Device Week, Oct. 18, 2018: Digital Health Market Intelligence; New Blood Therapies
October 18, 2018 20:05 - 11 minutes - 21.6 MBIn this edition of Device Week, Medtech Insight’s Marion Webb gives an overview of her new Market Intelligence article on innovative digital technologies applied to cardiology and Catherine Longworth reports on a Hermarina – a company in Brittany helping to build France’s ‘blue economy’ based on marine resources – which has developed several products, including a blood-replacement therapy, from a certain type of sandworm. For more information on Medtech Insight and to start a free-trial, cl...
Device Week, Oct. 12, 2018 – US Midterm Elections: What’s At Stake For Medtech?
October 12, 2018 18:08 - 8 minutes - 16.1 MBMedtech Insight senior reporters Ferdous Al-Faruque and Sue Darcey talk about how the upcoming US midterm elections could shake things up for the medical device industry in this week’s podcast. Medtech Insight articles addressing topics discussed in this episode: • Lots of Oversight But Little Legislation Expected If Dems Take House https://bit.ly/2QL6bqs • Device Industry Champion Erik Paulsen In Tough Election Fight To Retain House Seat https://bit.ly/2yvmCj2
Device Week, Oct. 5, 2018 – Everybody Wants Medtech In Their Backyard
October 04, 2018 21:07 - 11 minutes - 20.9 MBIn this edition of Device Week, Medtech Insight’s Reed Miller and Catherine Longworth discuss the efforts of national, regional, and local governments to bring in medtech investment, discussing examples from Lithuania, Ireland, and Texas. Brexit Trade Deal Must Wait, But UK Medtech Sector Finds Reasons To Be Cheerful https://bit.ly/2xZ6Uxt UK Device Manufacturers Must Contingency Plan For A Hard Brexit https://bit.ly/2yl82IO Innovation Driving Ireland's Transition From Medtech Supplier To...
FDA’s Schwartz Talks Cybersecurity Bonanza
October 04, 2018 21:02 - 31 minutes - 57.7 MBCoinciding with Cybersecurity Awareness Month in October, FDA’s Suzanne Schwartz talked to Medtech Insight about a slew of related initiatives to bolster connected security on medical devices but argues however the agency needs more resources to be effective.
Device Week, Sept. 28, 2018 – Data, Digital, Engagement And Trade At The MedTech Conference
September 28, 2018 18:37 - 12 minutes - 23.2 MBOn this week's podcast, we discussed some key takeaways from this week's MedTech Conference, including a significant focus on the need for device companies to become data companies and establish new ways to directly engage patients to compete in the new digital reality. Also, some FDA digital health updates, and discussion of the China tariffs. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR. Medtech Insight articles addressing topics discussed ...
Device Week, Sept. 21, 2018 – Medtech’s Next Top Maturity Model, Part 4
September 21, 2018 20:01 - 11 minutes - 21.8 MBMedtech Insight’s Shawn M. Schmitt talks about Part 4 of “Medtech’s Next Top Maturity Model,” his feature series on the appraisal of device-makers’ manufacturing capability and maturity. This episode focuses on appraisers affiliated with Pittsburgh's CMMI Institute and describes the hurdles they must jump to be part of a US FDA pilot program that uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) framework. Medtech Insight articles addressing topics discuss...
Scott, Crist Discuss Change In AdvaMed Leadership
September 20, 2018 21:38 - 14 minutes - 26.8 MBAfter announcing his departure from AdvaMed, JC Scott, the long running chief advocacy officer, and his successor Greg Crist, the current top public affairs officer, talked to Medtech Insight about their legislative agenda and future priorities.
Device Week, Sept. 13, 2018 – A Big Week For LivaNova; Creavo Seeks Cardiac Test Breakthrough
September 13, 2018 21:21 - 8 minutes - 15.5 MBIn this edition of Device Week, Medtech Insight’s Reed Miller talks to editor David Filmore about the latest good news for LivaNova and London-based reporter Catherine Longworth provides and update on Creavo Medical, a UK-based company using an old technology for a new kind of cardiac diagnostic that could save hospitals a lot of money in the treatment of patients suspected of having a heart attack. For more information on Medtech Insight and to start a free trial https://medtech.pharmaint...
CDRH Director Discusses Uncertainty Guidance
September 06, 2018 21:05 - 7 minutes - 12.9 MBCDRH Director Jeff Shuren spoke to Medtech Insight at the MDIC Annual Forum about a risk-benefit uncertainty guidance US FDA released that day. He says he hopes the guidance will provide clarity to industry about the circumstances when FDA will accept different levels of uncertainty.
Device Week, Sept. 6, 2018 – Medtech On The ‘Edge’
September 06, 2018 20:19 - 7 minutes - 13.5 MBOn this week’s podcast, Medtech Insight’s Ferdous Al-Faruque and Shawn M. Schmitt discuss “The Bleeding Edge,” a new Netflix documentary by Oscar-nominated director Kirby Dick that is highly critical of the medical device industry and US FDA. Medtech Insight article addressing topics discussed in this episode: • Top Medtech Lobbyist Doubts Legislative Repercussions Of New Netflix Documentary https://bit.ly/2wmlb6t
AdvaMedDx’s Van Meter On Regulatory, Legislative Diagnostics Priorities
August 31, 2018 19:48 - 22 minutes - 41.2 MBSusan Van Meter, executive director of AdvaMedDx, sat down with Medtech Insight to talk about what she’s learned in the nine months on the job and what issues she’s focusing on to represent the interests of the diagnostics industry.
Device Week, Aug. 29, 2018 – Medtronic’s Uplifting Figures And Data
August 29, 2018 10:23 - 10 minutes - 18.9 MBThe medtech industry’s number one player, Medtronic, is the focus of this edition of Device Week, as the firm hit the headlines with some impressive first fiscal quarter results and positive data from a trial of its Synchromed II drug infusion pump. Medtech Insight’s Reed Miller and Tina Tan chat about what helped to boost the company’s top- and bottom-lines and delve deeper into the SISTERS trial for Synchromed and the impact these results will have on the company’s pain management business....
Device Week, Aug. 22, 2018 – Quality System Regulation + ISO 13485 = ?
August 22, 2018 17:21 - 11 minutes - 21 MBOn this week’s podcast, Medtech Insight’s Shawn M. Schmitt talks about his recent reporting on US FDA’s plans to merge its bedrock rule for manufacturing safe and effective devices in the United States with international quality systems standard ISO 13485. Medtech Insight article addressing topics discussed in this episode: • QSR Author Kim Trautman Predicts What A Mash-Up Of FDA's Quality System Regulation And ISO 13485 Might Look Like https://bit.ly/2wbVDbg • The QSR/ISO 13485 Maze: How FD...
Podcast: FDA’s Peiris Discusses Lessons From Pediatric Devices Workshop
August 20, 2018 17:39 - 13 minutes - 25.1 MBMedtech Insight caught up with FDA’s Vasum Peiris immediately after a two-day workshop on pediatric medical devices to discuss what the agency learned and how the field may change based on the discussions.
Device Week, Aug. 14, 2018 - Liquid Biopsy Market Outlook
August 15, 2018 19:31 - 6 minutes - 11.8 MBIn this edition of Device Week, Medtech Insight's Reed Miller chats with Marion Webb about her latest Market Intelligence story focusing on the liquid biopsy market and emerging companies. 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: Market Intel: Liquid Biopsy I - Analyzing Market Landmarks and Landmines https://bit.ly/2w6lEZz