Tag: CE mark
Hyperflex balloon catheter by Endovastec receives marketing approval in Japan
Shanghai MicroPort Endovascular MedTech (Endovastec) recently announced that it has received registration approval from Japan Pharmaceuticals and Medical Devices Agency (PMDA) for the Hyperflex...
Medtronic receives CE mark approval for radial artery access portfolio
Medtronic today announced it has received CE mark approval for its radial artery access portfolio, which includes the Rist radial access selective catheter and the Rist...
Endologix receives CE mark for Alto abdominal stent graft system
Endologix recently announced that it has received a CE mark for the Alto abdominal stent graft system.
“We are very excited to receive a CE...
iVascular launches Sergeant peripheral support catheter
iVascular recently announced the launch of its Sergeant peripheral support catheter. Sergeant is a CE marked over-the-wire catheter, indicated for patients with peripheral arterial...
Merit Medical’s Wrapsody System receives CE mark
Merit Medical has received CE mark approval for the Wrapsody endovascular stent graft system from the British Standards Institution. The Wrapsody system is a...
CryoLife receives CE mark for On-X Ascending Aortic Prosthesis
CryoLife has announced it has received CE mark for the On-X Ascending Aortic Prosthesis (AAP), allowing resumed distribution in the European Union (EU). The...
Fist Assist announces CE mark and European launch
Fist Assist Devices has received CE mark and has begun marketing the Fist Assist device for vein enhancement and enlargement in the European Union...
XableCath crossing catheters have received CE mark for peripheral use
XableCath has announced that its XableCath Crossing catheters have received CE mark for peripheral use. Its crossing devices will be available for sale in...
Profusa wins CE mark approval for real-time tissue oxygen monitoring platform
Profusa has announced that it has received Conformité Européenne (CE) mark approval to market its Wireless Lumee Oxygen platform for continuous, real-time monitoring of...
CryoLife receives CE mark for E-nside thoracoabdominal stent graft
CryoLife recently announced that it has received CE mark for the E-nside thoracoabdominal aortic aneurysm (TAAA) multibranch stent graft system for the endovascular treatment...
Medtronic announces Shonin approval and launch of the Valiant Navion thoracic...
Medtronic today announced Shonin approval from the Ministry of Health, Labour and Welfare (MHLW) and the launch of the Valiant Navion thoracic stent graft...
PIUR Imaging launches wireless tomographic ultrasound system
PIUR Imaging has launched a portable version of its tomographic ultrasound system to the European market. The new CE-marked PIUR tUS Infinity is a...
Endologix announces reinstatement of CE mark for its Nellix endovascular aneurysm...
Endologix recently announced that the EC Certificate of Conformity (CE mark) for the Nellix endovascular aneurysm sealing system (Nellix system) has been reinstated by...
Nellix system CE Mark suspended
The CE Mark for the Nellix endovascular aneurysm sealing system (Endologix) has been suspended by its Notified Body, GMED, following a voluntary recall and...
First-ever CE mark of a bioresorbable scaffold for below-the-knee PAD
Reva Medical, a company developing bioresorbable polymer technologies for vascular applications, has announced that its Motiv bioresorbable scaffold is the first drug-eluting bioresorbable scaffold...
Terumo gets CE mark for Kanshas drug-coated balloon catheter for lower...
Terumo has announced that it acquired CE mark for the Kanshas drug-coated balloon catheter used in the treatment of lower extremity peripheral arterial disease....
Endologix’ Nellix receives CE mark with refined Instructions for Use
Endologix has been granted CE mark approval for its Nellix endovascular aneurysm sealing system, with refined Instructions for Use (IFU). Nellix is being studied...
Micro Medical Solutions receives CE mark for MicroStent
Micro Medical Solutions (MMS) has received CE mark approval for MicroStent, allowing the company to market this technology in Europe. MicroStent is a vascular...
CE mark reinstated for Endologix AFX and AFX2 systems
The CE mark for Endologix’ AFX and AFX2 endovascular abdominal aortic aneurysm systems has been reinstated, effective immediately.
The CE mark was temporarily suspended due...
Bentley receives CE mark for new BeGraft aortic stent graft
In November 2016, Bentley launched its BeGraft aortic stent graft system: a balloon expandable, large diameter covered stent with sizes ranging from 12mm to...
Ra Medical Systems receives European approval for DABRA atherectomy and Pharos...
Ra Medical Systems has received CE mark approval for both the DABRA atherectomy system with catheter and the Pharos excimer laser to treat psoriasis,...
