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 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...
Insightec receives FDA IDE approval for prostate cancer comparative study using...
Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care, announced that it has received US Food and Drug Administration...
CMS approves coverage for PQ Bypass TORUS 2 IDE trial
PQ Bypass announced today that it has received approval for coverage from the Centers for Medicare and Medicaid Services (CMS) for the Investigational Device...
First patients enrolled in Wing-IT investigational device exemption clinical trial
Reflow Medical announced that the first patients have been enrolled in a prospective, multicentre, non-randomised study intended to evaluate the ability of the Reflow...
Latest data on Lutonix and IN.PACT drug-coated balloons in AV access...
There in an increasing physician interest in exploring the role of drug-coated balloons in arteriovenous (AV) access. At the Leipzig Interventional Course (LINC; 30...
First patient enrolled in investigational study of Gore Excluder conformable endoprosthesis...
W L Gore and Associates has announced the first implant of the Gore Excluder conformable abdominal aortic aneurysm endoprosthesis in the USA. The procedure...
US FDA grants Medtronic investigational device exemption for new In.Pact Admiral...
Medtronic has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate a study of the In.Pact Admiral...
