Johnson & Johnson MedTech and Oscor, the company’s manufacturing partner, received reports of the sheaths leaking in ways that could result in access-site bleeding.
Medtronic's Affera Mapping and Ablation System with the Sphere-9 Catheter. Images courtesy of Medtronic.
The Affera Mapping and Ablation System with Sphere-9 Catheter can now be used to treat more patients in Europe. Medtronic also received good news from the FDA about the all-in-one device.
TAVR continues to gain momentum as a go-to treatment option. A group of experts convened at CRT 2026 to discuss where the field stands today and what questions remain unanswered.
The FDA has authorized four new flavored nicotine pouches, highlighting their potential to help adults stop smoking cigarettes. The American Heart Association shared its concerns with the move, saying "key questions" remain unanswered.
Vexev, an Australian medtech company, wants to improve patient access to high-quality vascular imaging. The company has now raised a total of $19 million.
![A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]](/sites/default/files/styles/top_stories/public/2024-09/istock-1209664264.jpg.webp?itok=gQInU1vO)
