Citeline Podcasts

In this edition of Device Week, Medtech Insight’s Marion Webb talks to UK-based reporter Barnaby Pickering about Cognetivity’s FDA approved diagnostic tool for Alzheimer’s. The company hopes that by providing earlier diagnosis, cost savings in the trillions of dollars can be made. Reed Miller also discusses Boston Scientific’s new “Modular” cardiac rhythm management system. They launched the trial of their Modular system that includes both a subcutaneous ICD and a leadless pacemaker, with positive results expected.

Medtech Insight articles addressing topics discussed in this episode:

- Exec Chat: Cognetivity’s Simple Brain Test Could Unlock Trillions In Health Care Savings

- Boston Scientific Advances First ‘Modular’ Cardiac Rhythm Management System

In this month’s podcast, Medtech Insight's Reed Miller, Marion Webb, Ferdous (Danny) Al-Faruque and Barnaby Pickering provide a recap of our digital health coverage in November including interviews with Medtronic, Abbott and Congenica, partnerships and launches, and AI and cybersecurity announcements.

Medtech Insight articles addressing topics discussed in this episode:

Congenica Tries To Bring Clarity To Personalized Medicine For Rare Diseases

https://medtech.pharmaintelligence.informa.com/MT144723/Congenica-Tries-To-Bring-Clarity-To-Personalized-Medicine-For-Rare-Diseases

Abbott Focuses On Improving Early Diagnosis Of Vascular Disease To Improve Outcomes

https://medtech.pharmaintelligence.informa.com/MT144796/Abbott-Focuses-On-Improving-Early-Diagnosis-Of-Vascular-Disease-To-Improve-Outcomes

Exec Chat: Medtronic’s Linnea Burman Targets ‘Consensus-Driven Care’ Using AI, Robotics in Spine Care

https://medtech.pharmaintelligence.informa.com/MT144753/Exec-Chat-Medtronics-Linnea-Burman-Targets-ConsensusDriven-Care-Using-AI-Robotics-In-Spine-Care

Medtronic Partners With Rune Labs To Explore New Frontiers In Deep Brain Stimulation

https://medtech.pharmaintelligence.informa.com/MT144681/Medtronic-Partners-With-Rune-Labs-To-Explore-New-Frontiers-In-Deep-Brain-Stimulation

Cala Health Hopes To Jolt Essential Tremor Market With Wrist-Worn Non-Invasive Stimulation

https://medtech.pharmaintelligence.informa.com/MT144742/Cala-Health-Hopes-To-Jolt-Essential-Tremor-Market-With-Wrist-Worn-Non-Invasive-Stimulation

Northwell Health And Aegis Ventures Form An Artificial Intelligence Joint Venture

https://medtech.pharmaintelligence.informa.com/MT144673/Northwell-Health-And-Aegis-Ventures-Form-An-Artificial-Intelligence-Joint-Venture

Podcast: How Do You Protect Yourself When Your AI Makes Mistakes?

https://medtech.pharmaintelligence.informa.com/MT144761/Podcast-How-Do-You-Protect-Yourself-When-Your-AI-Makes-Mistakes

AI Expert: Awareness Is Key To Managing Biases

https://medtech.pharmaintelligence.informa.com/MT144747/AI-Expert-Awareness-Is-Key-To-Managing-Biases

Researchers Find Serious Cybersecurity Vulnerabilities In Siemens Operating System Software: Report

https://medtech.pharmaintelligence.informa.com/MT144706/Researchers-Find-Serious-Cybersecurity-Vulnerabilities-In-Siemens-Operating-System-Software-Report

US FDA-Sponsored Cybersecurity Threat Modeling Playbook Tries To Make It Simple

https://medtech.pharmaintelligence.informa.com/MT144784/US-FDA-Sponsored-Cybersecurity-Threat-Modeling-Playbook-Tries-To-Make-It-Simple

Minute Insight: Kaia Health Stretches Access To Online Physical Therapy With Luna Deal

https://medtech.pharmaintelligence.informa.com/MT144711/Minute-Insight-Kaia-Health-Stretches-Access-To-Online-Physical-Therapy-With-Luna-Deal

Minute Insight: Philips Continues Building Monitoring Business By Acquiring Cardiologs

https://medtech.pharmaintelligence.informa.com/MT144704/Minute-Insight-Philips-Continues-Building-Monitoring-Business-By-Acquiring-Cardiologs

Cures 2.0 Throws MCIT A Lifeline, And More

https://medtech.pharmaintelligence.informa.com/MT144735/Cures-20-Throws-MCIT-A-Lifeline-And-More

Telehealth Advocates Disappointed, Reenergized To Get Coverage For Older Diabetes Patients

https://medtech.pharmaintelligence.informa.com/MT144702/Telehealth-Advocates-Disappointed-Reenergized-To-Get-Coverage-For-Older-Diabetes-Patients

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In this episode of Speaking Of Medtech we discuss the Medical Device User Fee Amendments, or MDUFA, the negotiations for which come around every five years. The MDUFA V talks between industry and the US FDA appear with the inevitability of an unloved season – it seems no one is ever terribly excited to engage in the user-fee process. Here, we break things down.

Medtech Insight articles addressing topics discussed in this episode:

FDA Official: Uptick In PMA, 510(k) Applications Calls For More User Fee Dollars

https://medtech.pharmaintelligence.informa.com/MT144795/FDA-Official-Uptick-In-PMA-510k-Applications-Calls-For-More-User-Fee-Dollars

MDUFA IV Report: US FDA Needs To Publish Digital Health Guidance

https://medtech.pharmaintelligence.informa.com/MT144544/MDUFA-IV-Report-US-FDA-Needs-To-Publish-Digital-Health-Guidance

US FDA’s Shuren Promises MDUFA Update ‘Relatively Soon’

https://medtech.pharmaintelligence.informa.com/MT144512/US-FDAs-Shuren-Promises-MDUFA-Update-Relatively-Soon

MDUFA V: Industry, FDA Tangle Over TAP Program, Agency Finances, Reinstatement Of Fifth-Year Offset Funds

https://medtech.pharmaintelligence.informa.com/MT144183/MDUFA-V-Industry-FDA-Tangle-Over-TAP-Program-Agency-Finances-Reinstatement-Of-FifthYear-Offset-Funds

MDUFA V: FDA And Industry Still At Odds Over Carryover Funds, Vacancies, Meeting Commitments

https://medtech.pharmaintelligence.informa.com/MT143859/MDUFA-V-FDA-And-Industry-Still-At-Odds-Over-Carryover-Funds-Vacancies-Meeting-Commitments

Nearly three quarters of the UK adults suffer from sleep problems, yet the majority of them do not seek help. In this episode, HBW Insight's Senio Editor, Europe, David Ridley, speaks to Perrigo VP and PAGB president Neil Lister about what consumer healthcare companies can do to help sleep-deprived British consumers. We talk about UK sleep brand Nytol-owner Perrigo's new report, State of the Market Report on Sleep, and how adjacencies in the OTC sleep category offer opportunities for self-care product innovation.

Scrip’s Five Must-Know Things – 6 December 2021 by Citeline

Pink Sheet reporters and editor review Acting Commissioner Janet Woodcock’s long career at the US FDA and update Robert Califf’s confirmation process, consider the advisory committee decision on Merck’s oral COVID-19 treatment, and discuss an under-the-radar case on 340B policy at the US Supreme Court.

In this week’s podcast, EU regulatory editor Amanda Maxwell brings listeners up to speed on the latest news from the European Union, including recent module updates and compliance expectations for the Eudamed database.

APAC Podcast: Policies Play Out Against Pandemic, Corporate Activity Remains Strong by Citeline

Scrip’s Five Must-Know Things – 29 November 2021 by Citeline

Medtech Insight spoke with Sidley Austin attorneys about the future of medical device AI negligence litigation and what manufacturers can do to protect themselves.