Canada
The US Food and Drug Administration (FDA) draft guidance limits tissue biopsy collection in clinical trials to primary endpoints and specific research use cases.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.
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.
Medtech promotes more women to managerial roles than other industries, but senior leadership positions see a significant drop in women representation, indicating a "broken rung" higher up in the leadership ladder.
Five guiding principles for PCCPs for ML devices exemplify international harmonization efforts from regulators.
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. Forty-three documents have been posted on the tracker since its last update.
Keeping press releases about a product on the manufacturer's website landing page for more than a year may be considered to be promotional, according to Health Canada's update guidance that includes myriad revisions, including a new section on using social media.
The Canadian government says stakeholders are “poised for action” to improve the collective response to medical product shortages and has come up with some questions and possible answers as to how best to go about it.