Venock Reports Safety/Efficacy of Its Automated Closure Device for Large Bore Venous Access Sites as Alternative to Standard Manual Compression of Veins/Arteries in Interventional...
The Venock device is designed to attain large-bore venous closure in under a minute.
Smith+Nephew REGENETEN Bioinductive Implant New Study
Smith+Nephew (LSE:SN,NYSE:SNN), the global medical technology business, today announces study results showing patients treated with just its REGENETEN Bioinductive Implant for partial-thickness rotator cuff...
AnchorDx’s Non-invasive Bladder Cancer Early Detection Test, UriFind, Earns “Breakthrough Device Designation” from FDA
Compared with the traditional gold standard cystoscopy for bladder cancer detection, UriFind is non-invasive, painless, and easy to operate allowing for the accurate detection of bladder cancer by simply collecting random urine, providing the Test and conducting methylation detection of exfoliated cell DNA in urine.
FDA Grants Breakthrough Designation to Synapse Biomedical’s TransAeris® System
"The Breakthrough Device designation for our TransAeris temporary diaphragm stimulation system is built upon our 20-year experience with NeuRx diaphragm pacing," said Anthony Ignagni, President & CEO of Synapse Biomedical.
Late-Breaking Trial Data at TVT Demonstrate Sustained Safety and Performance of WATCHMAN FLX™ Left Atrial Appendage Closure Device
Key findings include: The trial met its secondary effectiveness endpoint – defined as the occurrence of ischemic stroke or systemic embolism over 24 months – with a rate of 3.4% compared to the performance goal of 8.7%.
No patients experienced a device embolization or pericardial effusion requiring cardiac surgery through 24 months.