In heart valves, the advent of new, less invasive procedures promises the usual advantages over open surgery and more; lower cost, reduced procedural morbidity, faster healing times, and also, a new kind of intermediate treatment option that could serve new patient groups. Most companies are still in development; two companies have begun clinical trials in a handful of patients. But despite the early stage of the field, it's incited a great deal of controversy, particularly afer heart surgery company Edwards Lifesciences acquired the leading percutaneous valve company for what many view as a surprisingly large chunk of money. Central to the debate is the continuing (and uncertain) role of cardiovascular surgeons, the heart valve experts, once the referring cardiologists get their hands on their own procedure.
By Mary Stuart
Who could blame cardiac surgeons for being paranoid? Over the past several years, interventional cardiologists have hardly been loath to venture, with a catheter, where they've never gone before. And...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel
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.
Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.
The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.
The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.