Tags : CE Mark

MedTech Regulatory

Abbott’s TriClip Transcatheter Tricuspid Valve Repair System Receives the CE

Shots: The CE Mark approval is based on TRILUMINATE study with positive six-month data assessing edge-to-edge repair technique using TriClip and resulted in reduced severity of TR with improvement in functional capacity, Published in Lancet 2019 The TriClip device is based on the successful usage of Abbott’s MitraClip device which is novel transcatheter mitral valve […]Read More


Fujifilm’s CAD EYE Receives CE Mark to Support the Detection

Shots: Fujifilm’s CAD EYE receives CE mark, backing the real-time detection of colonic polyps during colonoscopy utilizing AI, will be available with software EW10-EC01 and the compatible expansion unit EX-1 in combination with the ELUXEO 7000 system CAD EYE utilizes FUJIFILM’s REiLi AI technology and can perform complex segmentation of 2D/3D images, spot lesions & […]Read More

COVID-19 MedTech

Co-Diagnostics Receives CE Mark for its Logix Smart Coronavirus PCR

Shots: Co-Diagnostics’ Logix Smart COVID-19 test has received CE mark as an IVD for the diagnosis of SARS-CoV-2 (COVID-19) and in now available at company’s Utah-based ISO-13485:2016 certified facility The Declaration of Conformity for the Logix Smart COVID-19 test confirms that it meets the essential requirements of the European community’s IVDD, permitting export and sales […]Read More


Abbott’s Gallant ICD and CRT-D Device Receives CE Mark in

Shots: Gallant implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices offer patients engagement and remote monitoring via smartphone to patients with abnormal heart rhythms & HF The Gallant system pairs with Abbott’s secure myMerlinPulse mobile app to improve the connectivity b/w the doctors & patients. The app allows the physician to monitor patients […]Read More