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J & J ’ s Cerenovus wins FDA nod for Embotrap II revascularization device
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus said today it won FDA 510(k) clearance for the Embotrap II revascularization device. The Irvine, Calif.-based J&J division said that the device is designed to quickly restore natural blood flow by retrieving emboli within the vasculature of the brain, using minimal compression to protect against further complications. Approval of the device came based on data from the Arise II study, in which investigators reported being able to restore blood flow in 80% of patients treated within three passes, and in approximately 50% within a single pass. More than 66% of patients ...
Source: Mass Device - May 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Neurological Regulatory/Compliance Vascular cerenovus johnsonandjohnson Source Type: news

MassDevice.com +5 | The top 5 medtech stories for May 19, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. The key components of a well-designed wearable: Sense, analyze, act One of the earliest uses of a wearable technology was recorded during Emperor Nero’s rule over the Roman Empire from 54 to 68 AD. A brutal leader, the empero...
Source: Mass Device - May 19, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news