Tag: IDE
Xeltis announces US FDA Breakthrough Device Designation for aXess and first...
Xeltis has today announced that the Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) has granted aXess...
Xeltis expands leadership team with appointment of Luc Verhees as vice...
Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, announces that it has appointed Luc Verhees...
Merit Medical to present six-month outcomes from randomised arm of WRAPSODY...
Merit Medical has announced today plans to release findings from its WAVE study. A pivotal, international, multicentre trial, the WAVE study examines the safety...
Xeltis appoints Shawn Gage as vice president of US clinical affairs
Xeltis has announced today the appointment of Shawn Gage as its new vice president of US clinical affairs. The company stated that his appointment...
Xeltis receives IDE approval from US FDA for haemodialysis vascular access...
Xeltis has announced that it has gained approval from the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) submission to...
Second US clinical study for Alucent Biomedical’s AlucentNVS technology receives US...
At the beginning of November 2023, Alucent Biomedical announced via press release that it has received a US Food and Drug Administration (FDA) investigational...
First subjects enrolled in US clinical trial for VenoStent
VenoStent has announced that the first subjects have been enrolled in the SAVE-FistulaS clinical trial, which will take place at two different sites across...