Citeline Podcasts

US FDA released a working model for their digital health pre-certification program as part of a broader Digital Health Action Plan. FDA's Bakul Patel spoke to Medtech Insight about what the agency is hoping to achieve with the new model.

In this edition of Device Week, Tina Tan chats to Elizabeth Orr on recent patent rulings, one related to an ongoing battle between TAVR rivals Boston Scientific and Edwards Lifesciences and another related to the broader area of challenging patent judgements. She also speaks to David Filmore to find out more details about CMS’s annual hospital inpatient proposal which it has just issued and how the new reimbursement rates would impact industry.

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

Here are a couple of other Medtech Insight articles related to patent rulings and reimbursement:

Boston Sci Wins Latest TAVR Patent Dispute Against Edwards

https://protect-us.mimecast.com/s/ZLUJCgJxkgiAGxZMgHyZzZ1?domain=medtech.pharmaintelligence.informa.com

Orthopedists Asked CMS To Stop Mandatory Bundled-Pay Models

https://protect-us.mimecast.com/s/8M--CjRvnlfnRMQW6SY1Le1?domain=medtech.pharmaintelligence.informa.com

In this week’s Medtech Insight podcast, we discuss US FDA Commissioner Scott Gottlieb’s big plan to boost medical device safety and quality, important news regarding cybersecurity, and the latest on a Medtronic clinical trial.

In this edition of Device Week, Tina Tan speaks to Catherine Longworth on Israel's push to become a global leader in digital health and Marion Webb on how science fiction is becoming reality in the operating room as surgeons take up technologies such as virtual, augmented and mixed reality to bring real benefits to patients.

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:

Israel On Quest For Digital Health Domination

https://medtech.pharmaintelligence.informa.com/articles/2018/04/10/israel-on-quest-for-digital-health-domination

Market Intel: When Reality Techs Kick In - How VR, AR And MR Are Revolutionizing Surgery

https://medtech.pharmaintelligence.informa.com/articles/2018/04/03/market-intel-when-reality-techs-kick-in--how-vr-ar-and-mr-are-revolutionizing-surgery

After a meeting of FDA experts convened to talk about capillary blood glucose meters used in hospitals, Courtney Lias, division director of Chemistry and Toxicology Devices spoke to Medtech Insight about her takeaways.

On this week's podcast, Shawn Schmitt discussed his recent reporting on US FDA warning letter trends, including a record-low letter count last year and what might be contributing.

Medtech Insight articles addressing topics discussed in this episode:

FDA Sends Record-Low Warning Letters To Device-Makers In 2017 As Agency Takes More Personalized Compliance, Enforcement Tack https://bit.ly/2q39s8M

During the wait between the CMS NTAP town hall in February and the proposed rule on which products will receive an add-on payment, expected in April, Prevision Policy analysts Laura Helbling and Ramsey Baghdadi share their thoughts on drugs seeking NTAPs, recommendations by BIO and the Alliance for Regenerative Medicines to modify NTAP for regenerative medicines, and FDA’s stance that its Breakthrough and RMAT designations don’t mean the agency has determined a drug is an improvement over existing therapy.

On this week's podcast, we discuss Brexit. UK and EU leaders announced some progress on Brexit this week, establishing a conditional transition period after the UK exits the Union in 2019. But that does not resolve many questions and concerns in the medtech space of what's to come. Here is a deep dive into where things stand. 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:

Brexit To Force Large-Scale Review Of Medtech Contractual Arrangements Throughout EU: https://bit.ly/2HSXJko

UK Medtechs Stress Need To Get It Right On Brexit As Prime Minister Addresses EU: https://bit.ly/2ueVhTw

One UK Notified Body To Be Phased Out This Year As It Moves To Sweden: https://bit.ly/2G1puqz

MedTech Europe CEO Shakes Up Industry On Brexit In Mission To Help It: https://bit.ly/2pwoeEU

Prepping For Brexit With Notified Body Switch Could Be Unnecessary Expense, BSI Warns: https://bit.ly/2pyokMm

A podcast discussion of three broader precedents stemming from the original Exondys 51 approval.

On this week's Device Week podcast, we discuss the medtech scene in Israel, the state of the glaucoma-therapy field, and the latest venture capital investments in medtech.