The FDA and medtech industry groups have agreed on a medical device user fee deal. Regulatory Affairs Professionals Society (RAPS) reported that while details are still being negotiated, the FDA reached an agreement on principle on a framework for the Medical Device User Fee Amendment (MDUFA V) on March 7. It will make the deal […]
AdvaMed
How medtech and pharma are responding to Russia’s invasion of Ukraine
Medtech and pharma companies continue to support Ukraine relief efforts following Russia’s invasion. Previously, the World Health Organization announced that it was sending “essential medical supplies” to Ukraine — including its first shipment of 36 metric tons of supplies for trauma care and emergency surgery and other health supplies — to meet the needs of more than […]
Medtech companies extend support to Ukraine humanitarian efforts
Medical device companies are continuing to make contributions to support the humanitarian emergency in Ukraine following Russia’s invasion of the country last month. Last week, Henry Schein, Siemens Healthineers, Conformis, Roche, Medicom and Philips announced initiatives to support the crisis, which included matching employee donations, sending supplies or donating money to support families in Ukraine. The […]
The MedTech Conference is coming to Boston in 2022
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 […]
An even larger medtech supply chain shock looms beyond the pandemic
Superstorms, fires, droughts and other extreme events driven by climate change are already straining the industry’s supply chain — and it could get a lot worse. Drifting wildfire smoke made for blazing sunrises and sunsets this summer in Minnesota, where electronics manufacturer Nortech Systems has been replacing air handling equipment to ensure particle filtration and […]
AdvaMed supports effort to overturn J&J pelvic mesh ruling in California
Medical device trade group AdvaMed announced today that it has filed an amicus curiae brief supporting an appeal to overturn a $344 million pelvic mesh ruling against Johnson & Johnson in California. Lawyers for AdvaMed tell the California Court of Appeal that the San Diego Superior Court judgment violated safe harbor protections because the case involved […]
Alva Health stroke monitor wins MedTech Innovator startup prize
MedTech Innovator has awarded its $350,000 global startup competition grand prize to Alva Health, the developer of a wearable, real-time stroke monitor. The New Haven, Connecticut-based startup won the medical device accelerator competition after a vote yesterday by attendees of The MedTech Conference, organized by AdvaMed. Get the full story at our sister site, Medical […]
AdvaMed honors former BD CEO Ludwig with its Lifetime Achievement Award
AdvaMed this week honored former BD CEO Edward Ludwig with its 2021 AdvaMed Lifetime Achievement Award. Ludwig received the award on September 27 during an in-person and live-streamed event as part of The MedTech Conference. Ludwig joined BD in 1979 and rose through the ranks to eventually become chair and CEO, retiring from the company in […]
CDRH’s Shuren says they’re ‘starting to turn the corner’ from COVID-19
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 […]
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 […]
AdvaMed wants feds to give medical supply chain priority
Medtech trade group AdvaMed wants the Biden administration to put the transport of medical supplies at the top of its list to address supply chain problems at ports worldwide. On his first day in office, Biden issued an executive order that promised, in part, to secure the pandemic supply chain and create a U.S. manufacturing base […]