Citeline Podcasts

Device Week, Sept 1, 2017: POC Testing And Eye Drug Delivery Trends

In this edition of Device Week, Medtech Insight’s Marion Webb and Tina Tan look more closely at the drivers that are accelerating the move away from centralized lab testing towards point-of-care settings like retail pharmacies, and highlight the challenges that still need to be addressed. They also delve into the ophthalmic space and look at what ocular drug delivery innovations are being developed to help fuel the fast growing ophthalmic drug market.

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:

Eye On The Prize: Drug Delivery Advances To Fuel Ophthalmic Drug Market http://bit.ly/2iq3oql

Voyage Into Point-Of-Care Testing Gets Deeper http://bit.ly/2elLIXZ

On this week's podcast, Medtech Insight's David Filmore and Ferdous Al-Faruque discuss the recently enacted FDA Reauthorization Act. It comes with higher industry fees, but also a host of FDA commitments and reforms. The legislation was broadly supported by lawmakers and industry alike, but President Trump? Not so much. For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR

In this week's Device Week podcast, we look at recent mergers and acquisitions. While the year starter out slow, July was the busiest month for medtech M&A deals. A this rate the industry is set to break last year's deal count. We go in-depth into some of the major deals and more.

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

Want to know more about medtech regulatory efforts in countries from Singapore to Myanmar to Russia, and more in between? In this week's podcast, Ashley Yeo provides an update from his reporting on what governments in the Asia and Eurasia regions are doing to focus on devices and diagnostics. Short answer: a lot.

Medtech Insight articles addressing topics discussed in this episode:

Medtech Associations Regulatory Networking, July 2017 – Singapore, the Philippines, Myanmar: http://bit.ly/2wuW9kb

Asia Reg Roundup: Vietnam On Track Launching New System, Plus Updates From Bangladesh, Hong Kong: http://bit.ly/2hLnivD

India Consults On ‘Essential Principles’ Ahead Of New Rules For Devices, IVDs: http://bit.ly/2uqtRpr

Mind 'Hidden' Regulatory Demands In Russia To Avoid Icy Chill Of Rejection, Expert Warns: http://bit.ly/2vP2qcr

Eurasian Medtech Agreement Clears Key Thresholds: http://bit.ly/2vnIsmL

Earnings season is in full swing with most big medtech names having already reported their latest quarterly results. In our Aug. 4 podcast, Tina Tan and Reed Miller review the performance of companies across specific sectors, including orthopedics, and what’s driving or limiting sales growth, as well as how some of the industry bellwethers are faring. For more, check out Medtech Insight: Medtech.pharmamedtechbi.com.

You can find our latest “Earnings Winners & Losers” articles here:

Earnings Winners & Losers: Orthopedics Firms, JNJ, NUVA, SNN, SYK, ZBH: http://bit.ly/2uqR0qV

Earnings Winners & Losers: The Large Diversified Firms, ABT, BAX, CAH, JNJ: http://bit.ly/2vwREqV

The Rose Sheet’s editorial team counts off top news items in the cosmetics and dietary supplement sectors in July. In this installment we discuss developments under the EU’s cosmetics animal-testing ban, cosmetic preservatives positioned for elimination, and a bill advancing in California that would tighten requirements for continuity marketing; On the supplement side, warning letters are issuing regularly, but investments in the industry also are up, with innovations in the areas of medical foods and probiotics helping to fuel interest.

Mike Ward, head of global content for Informa Pharma Insights, discusses opportunities for greater drug development efficiency with Drug Dev's Elisa Cascade and Informa's Karen Currie and Loni Branon.

Device Week – US Policy Roundup, July 28, 2017

In this week's podcast, Medtech Insight journalists discuss what was a busy week in Washington, DC – the health-care fail on Capitol Hill, and what it means for medtech; FDA's new plan for digital health; and one case to watch during the US Supreme Court's next term. For more, check out Medtech Insight: https://Medtech.pharmamedtechbi.com.

Medtech Insight articles addressing topics discussed in this episode:

• Health-Care Bill Failure Triggers Renewed Search For Device Tax Repeal Option

• Software At The Speed Of Trust: US FDA Launches Pilot To Expedite Digital Health Products

• US Supreme Court Case Could End Patent Office Reexamination Procedure

• Artificial Intelligence Brings Wave Of Future Health Care Innovation – Embrace it or be Left Behind

• Illumina Enters Second Wave Of Growth As Genomics Demand Swells

FDA’s Bakul Patel discussed the agency’s pre-certification pilot program formerly known as the precheck program. If successful the program would allow medical device sponsors to get their digital health products to market potentially sooner and more streamlined based on trust they build with FDA. In some cases sponsors may not even need to file a premarket application.

Tags: medical device, fda, pre-certification, precheck, bakul patel, digital health, digital health innovation action plan

On this week's Medtech Insight podcast: US Senate passes $2.8bn FDA spending bill; US approvals and clearances strong in first six months of 2017; the global heart-valve repair and replacement devices market is highlighted.