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 episode:

Market Intel: Hearing-Aid Companies' Use Of AI, Apps, New Tech Excites Audiologists; Global Hearing-Aid Market Will Reach $11Bn By 2023

http://bit.ly/2McmTyt

TCT 2019: Boston Scientific's Acurate Neo TAVR Misses Endpoint In SCOPE I

http://bit.ly/2Ovf61B

TCT 2019: New COAPT Results Support, Durability And Cost-Effectiveness Of Abbott’s MitraClip

http://bit.ly/2pnjDIV

TCT 2019: IDEAL LM Inconclusive, While Onyx ONE Boosts Polymer-Based DES

http://bit.ly/2nm1QkC

TCT 2019: Evolve Short DAPT And Model U-SUS Study Show Short DAPT Was Comparable To Longer-Term DAPT

http://bit.ly/2LJXNb3

TCT 2019: Five-Year PARTNER 2A Results Support TAVR In Most Intermediate Risk Patients

http://bit.ly/2MhYZS0

TCT 2019: TRILUMINATE Six-Month Results Support Abbott’s TriClip

http://bit.ly/3317Azi

TCT 2019: One-Year PARTNER 3 Outcomes Show Better Quality Of Life With TAVR

http://bit.ly/35a6V0b

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.

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• Industry Optimistic About Second CDS Draft Guidance; FDA Releases More Final Software Guidances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 Patient Limit

• Final Guidance Clarifies HDE Process, ‘Probable Benefit’

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 by Citeline

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

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.

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.

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 Security – Connected Health Summit Puts Spotlight On Independent Living

http://bit.ly/2k59gHl

Intuitive Surgical Opens New UK/Ireland HQ In Oxfordshire

http://bit.ly/2k593Uz

Assessing The Future Of Robotics In Medtech

http://bit.ly/2k5ztWc

International Demand For Robotic Surgery Drives Intuitive Surgical’s Revenues Up 21% in Q2

http://bit.ly/2m2viuU

Connected Health Summit: VCs Discuss Digital Health Investment

https://bit.ly/2kmStzL

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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.