David Filmore

#CMS unveiled its Transition Coverage for Emerging Technologies proposal last week—the agency’s second go-around at trying to streamline #Medicare coverage of innovative new devices. Here’s our initial analysis of the plan, with 10 key takeaways. ➡️ tinyurl.com/3y5bsk6c

The European Medicines Agency (@EMA_News) will launch a year-long pilot next month to give 10 makers of innovative devices the opportunity to get early feedback from EU expert panels on clinical trial planning to facilitate the MDR assessment process. #regulatory

What Do the US Midterms Mean for #Medtech? @medicaldevices's Mark Leahey and @AdvaMedUpdate's Greg Crist offer their perspectives on this podcast with Market Pathways editors Stephen Levin (@StephenLevinMTS) and David Filmore (@MedtechDavid). ➡ bit.ly/3P03sJe

#Regulatory Doc of the Week: "Guiding Principles for Safety and Effectiveness Evaluation of Medical Devices Using Nanomaterials Part III: Biological Compatibility/Toxicological Evaluation (Draft)" View the document here (link in Simplified Chinese). ➡️cmde.org.cn/xwdt/zxyw/202211…

China’s National Medical Products Administration is consistently one of the most prolific #regulatory agencies in publishing guidance and other #medtech policy documents. NMPA issued 26 documents last month— mostly technical review guidelines—to the US FDA’s 14.

We’re ready and excited for #MedTechCon in beautiful Boston presented by @AdvaMedUpdate. Check us out at Booth 213 and come meet our team. 👋

In this month’s spotlight from Pathways’ Document Depot, Malaysia and the Philippines roll out policy docs that build on the decade-long project to harmonize device regulations in Southeast Asia. ➡️ bit.ly/3eMjsR9 #regulatory #medtech

NEW #PODCAST EPISODE: "What in the (Medtech) World is Happening?" Market Pathways’ editors @StephenLevinMTS and @MedtechDavid talk about global #medtech policy issues they’ll be paying attention to this fall. Listen here. ➡️ bit.ly/3f4VjlR Expand to learn more. ⬇️

Congress or No Congress, “Full Steam Ahead” on #MDUFA V, Shuren says during a panel discussion at the #RAPSConvergence 2022 conference in Phoenix (convened by the @RAPSorg) by @MedtechDavid 📖 ➡️ bit.ly/3xnjrcK

This week's roundup includes steep industry fee hikes proposed by UK’s regulator, while #FDA and industry hope for quick action on US user fee reauthorization, and China institutes #electronic fee payments.

"Pathways’ Picks August 24: EU Panel Strikes Again, China Updates, and More," by @MedtechDavid, Executive Editor Get your picks here. ➡️ bit.ly/3AnbgO7

The new European Medical Device Regulation has been effective since May 26, 2021, but now comes the hard part: figuring out what it means and how it works. Senior @medtecheurope leaders Serge Bernasconi and Oliver Bisazza share their insights. ➡️bit.ly/35a1kfy #MDR

The revamping of its NTrainer neonatal feeding system with digital enhancements will enable @InnaraHealth to implement a subscription-based pricing model that overcomes lagging #reimbursement and traditional budgetary constraints.➡️ bit.ly/3bklIgF #medtech

NEW EPISODE: @Sandra Siami leads NEST Coordinating Center from her perch at the Medical Device Innovation Consortium. We spoke to Siami about the role NEST plays in industry, the challenges to establishing a robust real world evidence framework, and more.➡️bit.ly/3l977r7

Here is what you should expect in the newest Digital Edition of @Market_Pathways: • Racial Equity in Device Trials • MDUFA V a Done Deal • Switzerland & the UK Go it Alone • PDx Paths to Payment

"7 User Fee Riders to Watch: From Cybersecurity to Remanufacturing to Payor Comms," by @MedtechDavid #FDA and industry just spent more than a year negotiating a MDUFA V reauthorization agreement that is now before Congress. A thread. 👇

.@_bakulpatel will lead @US_FDA's Digital Health Equity Effort. Patel's new position is focused on bringing digital health technology to bear on expanding healthcare access to underserved populations.➡️bit.ly/3gZChxG @MedtechDavid