Canada
The US Department of Commerce’s investigation into the national security impact of importing various medical equipment could lead to tariffs on many products. Device industry responds by emphasizing the robustness of domestic production, but also the rigidity of supply and reimbursement agreements.
Excitement surrounds Multi Cancer Early Detection testing for diagnosing hard-to-detect cancers early and improving patient outcomes. But without full randomized trials – only accuracy studies – physicians lack enough evidence to use them confidently, said physician and researcher Daniel Jonas.
During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.
During his testimony before US senators on the impact of tariffs on critical supply chains, AdvaMed’s Scott Whitaker said the Trump tariffs could jeopardize America’s preeminence in medtech. Other industry experts echoed similar concerns.
Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.
Members of AdvaMed’s digital health tech board of directors discussed the organization’s efforts to aid the Trump administration and Congress in answering AI policy questions, especially as companies deal with mounting regulatory uncertainty.
In response to the Trump administration increasing its tariffs on imports from China, Beijing announced a ban on gene sequencers from US biotech firm Illumina, signaling a full-blown trade war could be in the making. Trump also pushed the deadline for implementing tariffs on Canada and Mexico back by another month.
The US Food and Drug Administration (FDA) draft guidance limits tissue biopsy collection in clinical trials to primary endpoints and specific research use cases. However, Andrew Newland, CEO of circulating tumor cell (CTC) liquid biopsy firm Angle Plc, believes that the guidance could enhance the market for liquid biopsy makers.
The UK's established emergency care prehospital system potentially opens up a faster route to market for Front Line Medical Technologies's aortic occlusion device, COBRA-OS. Asha Parekh, Front Line CEO, talks to Medtech Insight about the company's different strategic approach to UK market access in comparison to North America.
Concerns President Trump’s tariffs could create a full-blown trade war with China jumped dramatically as Beijing responded with its own set of tariffs targeting various US goods. On the medtech front, AdvaMed wants Trump to create a carve-out for Chinese medical devices as he did in his first term.
During the Medtech Conference in Toronto, three of the industry’s leading CEOs shared their insights into the rapidly changing landscape of health care and how the latest advancements have the potential to make life better for patients everywhere.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 30 documents have been posted on the tracker since its last update.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.
The principles urge device makers to look at the whos, whys and whats of device use in developing their data transparency approaches.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Sixty-five documents have been posted on the tracker since its last update.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifty-nine documents have been posted on the tracker since its last update.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.