Aggregator

BSCI’s LAAC CHAMPION-AF study for WATCHMAN FLX meets primary and secondary safety and efficacy endpoints

2 months 1 week ago

Data highlights the WATCHMAN FLX device provided statistically superior protection from bleeding, demonstrated similar efficacy compared to blood thinners in patients with non-valvular atrial fibrillation. Findings presented at ACC.26 and simultaneously published in The New England Journal of Medicine.

The post BSCI’s LAAC CHAMPION-AF study for WATCHMAN FLX meets primary and secondary safety and efficacy endpoints appeared first on MedTech Intelligence.

Rich West

Apple Store to ID Regulated Medical Device Apps

2 months 1 week ago

To provide additional transparency on the App Store, apps that are available in the European Union (EU)/European Economic Area (EEA), United Kingdom (UK), or United States (US), and that also meet either of the criteria listed below must indicate whether they’re regulated medical device with respect to each region’s regulatory authority or body responsible for the governance and compliance of medical devices.

The post Apple Store to ID Regulated Medical Device Apps appeared first on MedTech Intelligence.

Rich West