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
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A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.
Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.
As the EU Life Sciences Strategy aims to drive innovation, the medtech sector is pushing for a pivotal role in a mission intended to embrace green and digital transitions, address regulatory obstacles and reduce dependency on external sources.
The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.
As the EU Life Sciences Strategy aims to drive innovation, the medtech sector is pushing for a pivotal role in a mission intended to embrace green and digital transitions, address regulatory obstacles and reduce dependency on external sources.
Former FDA Commissioner Robert Califf urged the Heart Rhythm Society to engage actively amid federal funding cuts. He highlighted collaboration among researchers, advocates for healthcare integration, and the importance of addressing social determinants of health, while discussing lobbying strategies and the challenges faced by medtech companies.
Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.
