On this week's podcast, Reed Miller talked about the Medicare Evidence Development & Coverage Advisory Committee's recent gathering to discuss transcatheter aortic valve replacement coverage policies and the debate over hospital and physician volume requirements. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR.

Listen to the podcast via the player below:

Medtech Insight articles addressing topics discussed in this episode:

Medicare Advisors Mostly Favor TAVR Center Volume Thresholds: https://bit.ly/2K1pmII

CMS Is Taking Another Look At Its TAVR Coverage Rules: https://bit.ly/2vevpEK

CMS Policy Sets Boundaries On Transcatheter Valve Procedure: https://bit.ly/2AhBC8u

The issue of antimicrobial resistance (AMR) has been stalking global public health for a number of years - and governments, heath authorities and the international scientific community as a whole is finally starting to take action. In this podcast Mike Ward of Informa talks to Dr Peter Jackson, executive director of the AMR Centre, a public-private partnership, which is based at Alderley Park, Cheshire, and leads the UK response to the crisis.

In this edition of Device Week, Medtech Insight’s Tina Tan discusses trends in VC financing and M&A activity for medtech in 2018. Davide Filmore explains FDA’s latest approvals numbers, and Reed Miller gives an overview of the state of medical device approvals from outside the US.

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:

VC Deals Analysis: Mega-Rounds Abound, As H1 Deal Value Rockets Past $4Bn https://bit.ly/2LtnAVw

ReCor Deal Underscores RDN Revival – But Also Reason For Backing Medtech? https://bit.ly/2L5ymSM

US Device Approvals Q2 Snapshot: Cook Clearances Continue; Novel Device Approvals Pick Up https://bit.ly/2NvKKbr

Global Device Approvals Q2 Shapshot: Coronary Devices Abound https://bit.ly/2LuPMUS

Part 3 of Medtech Insight’s feature series on the appraisal of manufacturing capability and maturity – “Medtech’s Next Top Maturity Model” – is discussed on this week’s podcast. Author Shawn M. Schmitt gives details on how Baxter Healthcare, Edwards Lifesciences and other firms weathered their appraisals using the Capability Maturity Model Integration (CMMI) model and method.

Medtech Insight articles addressing topics discussed in this episode:

Boston Scientific, Edwards Lifesciences, Baxter Used CMMI To Measure Their Manufacturing Capability. Here's What They Said About The Experience https://bit.ly/2K69U34

Device-Makers Like Baxter Are Lining Up To Let CMMI Evaluate Their Manufacturing Site Capabilities. Here's What To Expect If You're Appraised https://bit.ly/2K6TWRV

Chasing Quality Isn't Easy. But An FDA Pilot Aims To Boost Quality By Appraising The Capability Of Manufacturing Sites https://bit.ly/2jGPlL1

In this edition of Device Week, Medtech Insight editor Marion Webb reports on the American Diabetes Association conference in Orlando and editor Reed Miller runs down the latest corporate restructuring news.

For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR

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Medtech Insight articles addressing topics discussed in this episode:

ADA2018: Insulet Reports Positive Clinical Results For Omnipod Horizon, Limited Market Release Of Dash

https://bit.ly/2J0Ajd4

ADA2018: Senseonics' Implantable CGM Beats Abbott, Dexcom In Head-To-Head Study – But Is Methodology Flawed?

https://bit.ly/2lXXBr6

ADA2018: Medtronic Touts Power of Artificial Intelligence, New Pediatric Indication, Payer Guarantee Program

https://bit.ly/2KNXZGB

GE Spins Off Healthcare As Part Of Major Reorganization

https://bit.ly/2tylKbJ

Bio-Techne Makes Big Push Into Liquid Biopsy With Exosome Acquisition

https://bit.ly/2NuiJBZ

Novartis Sees The Light And Plumps For Alcon Spin-Off

https://bit.ly/2u9qxjo

On this week's podcast, we discuss medtech matters that US lawmakers have on their radars, and issues that are coming up in the courts. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR. Learn more about the Medtech Insight Awards and enter nominations: https://bit.ly/2tMcQYD.

Medtech Insight articles addressing topics discussed in this episode:

bioMérieux America CEO Talks Dx Reform Progress, Antibiotic Resistance: https://bit.ly/2yQBBHQ

Servicing Company Points To Downsides In Third-Party Servicing Bill: https://bit.ly/2tLZiv2

Q&A: Ongoing Mishaps From Bad Device Fixes Argue For Third-Party Servicing Bill, Bayer Exec Says: https://bit.ly/2MWMTgR

Bills Calling For Non-Pharma Alternatives To Opioids Clear US House: https://bit.ly/2tGWccD

Market Intel: Peripheral Nerve Stim Players Edge Out Innovative Paths: https://bit.ly/2NdRuvg

Patent Office Judge Suing Medtronic For Wrongful Termination: https://bit.ly/2KuTJIQ

Boston Scientific Wins Pelvic Mesh Bellwether: Boston Scientific Wins Pelvic Mesh Bellwether

Informa Pharma Intelligence’s head of content Mike Ward and Generics Bulletin editor Aidan Fry discuss how US market pressures are making life tough for the generics industry.

On this week's podcast, we provide a roundup of recent guidance documents issued by US FDA on topics including humanitarian use devices to off-label communications. We also discuss the Medtech Insight Awards. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR.

Learn more about the Medtech Insight Awards and enter to win: https://bit.ly/2HqAuxv

Medtech Insight articles addressing topics discussed in this episode:

US FDA Tackles HDE 'Probable Benefits' Question In Draft Guidance: https://bit.ly/2l55mec

US FDA Encourages Broader Use of Popular IVD Coding Standard, Cautions Off-Label Use: https://bit.ly/2KbvHCu

FDA Finalizes Q&A Guidance Docs On Manufacturer Communications, Adding A Few More Details: https://bit.ly/2HKmU8vm

Guidewire, Catheter Draft Guidance Docs Address Coating Risks: https://bit.ly/2tBUeJZ

Calling A Q-Sub: New Guidance On Seeking Feedback From FDA: https://bit.ly/2KaJPz0

Listen to this podcast with Generics bulletin editor Aidan Fry and deputy editor David Wallace to find out:

· Tips to write a nomination that gets noticed

· How else you can be involved in the awards including complementary tickets

· The benefits of sponsoring

In this edition of Device Week, Medtech Insight’s Tina Tan and Catherine Longworth discusses the trends in M&A and venture fundraising activity seen this year so far. They touch on what areas are getting the most interest from investors and strategic buyers, and the most recent deals worth noting.

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:

VC Deals Analysis: Positive Exit Markets Keep Venture Investment Swell Growing

M&A Analysis – Acquisitions Come What May