What does the future hold for AI in medical devices?

(Image courtesy of the FDA)

Digital health, artificial intelligence (AI), machine learning and more — these concepts continue to generate buzz in the medtech world.

Last month, the FDA published guidance on clinical decision support (CDS) software. It helped to clear up what constitutes a medical device and what doesn’t. Early last year, the agency published a predetermined change control plan (PCCP) to help build a regulatory structure for such technology.

These topics and more spurred intriguing commentary on a panel at AdvaMed’s MedTech Conference in Boston today.

The panel featured viewpoints across all angles of the space. Dr. Yuri Maricich, CMO and head of development at Pear Therapeutics, offered thoughts from the developer of digital therapeutics. Brendan O’Leary, acting director of the Digital Health Center of Excellence at the FDA, provided the regulatory vantage po…

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The MedTech Conference is coming to Boston in 2022

[Boston image from Unsplash]

Trade group AdvaMed plans to return to an entirely in-person event for The MedTech Conference, with the annual event slated for Boston on October 24–26, 2022.

AdvaMed in September 2021 held a hybrid event that included virtual sessions as well as live sessions in Minneapolis and Washington, D.C. (The year before — in pre-COVID vaccine times — the event was entirely virtual.)

“We recognized the strong desire to gather in-person at our 2021 hybrid conference, and will continue to plan for a live event while closely monitoring the status of COVID-19 in the coming months. Rest assured, the safety of our staff and attendees remains our top priority,” AdvaMed EVP Ray Briscuso and SVP Wendy Siminski said in an announcement yesterday.

MassDevice and Medical Design & Outsourcing‘s DeviceTalks is also returning in 2022 with live events: Boston May 10–11, M…

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CDRH’s Shuren says they’re ‘starting to turn the corner’ from COVID-19

CDRH director Dr. Jeff Shuren [Image courtesy of FDA]

Medical device industry insiders will have to wait until the new year to get a better idea of the post-pandemic priorities at the FDA’s CDRH.

That was one of the big takeaways from Dr. Jeff Shuren’s remarks at the virtual CDRH Town Hall held yesterday at AdvaMed’s The MedTech Conference, which takes place this week as a combination of virtual presentations and live presentations events in Washington, D.C. and Minneapolis.

Shuren, the director of FDA’s Center for Devices and Radiological Health, said the center is “starting to turn the corner” on catching up on submissions. Additional dollars from Congress, he said, allowed CDRH to bring on more people, leverage contractors and make changes in policy and process.

FDA is even coming out of the COVID-19 pandemic with dedicated resources to establish a supply cha…

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The MedTech Conference by AdvaMed to be a mixture of in-person and virtual

To hold an event or not to hold a live event. Medtech trade association AdvaMed chose both for The Medtech Conference, which takes place next week.

The September 27–30 conference includes a mixture of virtual presentations and in-person events in Washington, D.C., and Minneapolis. AdvaMed CEO Scott Whitaker mentioned several conference agenda highlights during a news conference today:

Former U.S. Secretary of Defense Chuck Hagel will deliver an afternoon keynote on Monday, September 27, in Washington, D.C. CMS’s chief medical officer Dr. Lee Fleisher will discuss his work during a late morning talk on September 27. FDA’s Virtual CDRH Town Hall — a perennial favorite at the conference — will take place virtually on the evening of September 27. The in-person Minneapolis events September 29–30 include a who’s who of medtech CEOs, including Abiomed’s Michael R. Minogue (also the present AdvaMed board chair), Edwards Lifesciences’ Michael…
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AdvaMed announces The MedTech Conference will be virtual

The MedTech Conference, powered by AdvaMed, announced today that this year’s upcoming conference will be an all-virtual experience.

Originally scheduled to take place in Toronto, the conference will take place on a virtual platform. AdvaMed said in a news release that The MedTech Conference event in 2022 will now be hosted in Toronto.

Beginning in September, registrants for the event will have access to on-demand sessions, which will be released every week through Oct. 7. Additionally, a number of simulcast sessions will be available for viewing between Oct. 5 and Oct. 7, with sessions available on-demand through late October.

The conference’s MedTech Connect partnering platform will be open in August so participants will be able to view other users and begin requesting networking meetings.

“The MedTech Conference is the premier annual gathering of our industry, and it is more important than ever that we show, despite the challenges pr…

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