Citeline Podcasts

FDA 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.

In 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 Roll Out This Week

https://medtech.pharmaintelligence.informa.com/MT124798/FDA-Device-Center-Reorg-Set-To-Roll-Out-This-Week

• Neuro Devices Panel Skeptical On Alzheimer’s Treatment

https://medtech.pharmaintelligence.informa.com/MT124823/Neuro-Devices-Panel-Skeptical-On-Alzheimers-Treatment

One 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.

In 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-insights/medtech-insight

Medtech Insight articles addressing topics discussed in this episode:

AAOS 2019: OSSO VR Develops VR Training Tool For Smith & Nephew's NAVIO Robot, And More On Orthorobotics

https://bit.ly/2XOGuto

2018 Earnings Spotlight: Stryker And Nuvasive Lead The Ortho Pack In 2018

https://bit.ly/2TAB3je

Exec Chat: New Smith & Nephew CEO Namal Nawana Outlines Growth Strategy At JP Morgan

https://bit.ly/2GHcWIi

Results Recap: CRT In DC Features New Biotronik Stent Data, Encouraging TAVR Low-Risk Data; Ablative Systems’ Alcohol Renal Denervation

https://bit.ly/2W1CkfV

Drug-Coating Safety Risk Acknowledged At Cardiology Gathering, But Cause Remains Elusive

https://bit.ly/2TLcfEF

2018 Earnings Spotlight: Transcatheter Valve Repair Remains Big Drivers For Medtronic, Edwards, Abbott

https://bit.ly/2VIoQ8V

On 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 His US FDA Team To Stay Together After He Departs: https://bit.ly/2HkWQUO

In 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 Symposium in San Francisco on March 1, 2019.

In 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 Insight articles addressing topics discussed in this episode:

Breast Surgeons Advise All Breast Cancer Patients Be Offered Genetic Testing

https://medtech.pharmaintelligence.informa.com/MT124656/Breast-Surgeons-Advise-All-Breast-Cancer-Patients-Be-Offered-Genetic-Testing

2018 Earnings Spotlight: Transcatheter Valve Repair Remains Big Drivers For Medtronic, Edwards, Abbott

https://medtech.pharmaintelligence.informa.com/MT124703/2018-Earnings-Spotlight-Transcatheter-Valve-Repair-Remains-Big-Drivers-For-Medtronic-Edwards-Abbott

TCT 2018: Abbott Expects COAPT Results To Support Expanding MitraClip's Indication

https://medtech.pharmaintelligence.informa.com/MT123311/TCT-2018-Abbott-Expects-COAPT-Results-To-Support-Expanding-MitraClips-Indication

In 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 (LDTs) that they call the VALID Act.

Medtech Insight articles addressing topics discussed in this episode:

• Lab Groups Disagree With GAO That Medicare Will Be Overbilled For PAMA Test Payments

https://medtech.pharmaintelligence.informa.com/MT124672/Lab-Groups-Disagree-With-GAO-That-Medicare-Will-Be-Overbilled-For-PAMA-Test-Payments

Brian 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

Several 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.