Tenaxis Medical, a developer of high-performance sealants, has received approval to expand its CE Mark indications for ArterX surgical sealant, from its EU notified body, BSI. ArterX Surgical Sealant is specifically designed to be applied ...
US-based Fujifilm SonoSite received CE mark approval for its X-Porte ultrasound kiosk, a new generation of point-of-care ultrasound. This integrates advanced signal processing for high-resolution imaging, 3D animated clinical guides, and ...
Tags: SonoSite, Ultrasound Kiosk
Preventice, a developer of mobile health applications and remote monitoring systems, has received ISO 13485: 2003 certification for its quality management system. As per the ISO requirements of the quality management system, an ...
Tags: Preventice, health applications
Coherex Medical, a developer of medical devices, has obtained CE Mark approval for its Coherex WaveCrest left atrial appendage (LAA) occlusion system. WaveCrest LAA Occluder seals off the LAA opening so that blood clots cannot escape into ...
Tags: Coherex Medical, CE Mark
Tensys Medical has received CE mark for its latest generation non-invasive hemodynamic patient monitoring systems called the TL-400 and TL-300. This approval allows immediate commercialization of the systems in Europe. The TL-400 offers ...
Tags: CE Mark
CardioKinetix has announced the first successful procedure in four cardiac patients with its new catheter-based Parachute ventricular partitioning device in Kuala Lumpur, Malaysia. The new Parachute device is a new minimally invasive ...
US-based Aggredyne has obtained ISO 13485 certification for implementing rigorous quality control program related to the manufacture of the AggreGuide family of platelet function analyzers. The ISO 13485 certification covers the design, ...
Tags: Medical Device, CE Mark
Avinger, a manufacturer of multifunctional catheters, has received CE Mark approval for Pantheris, a lumectomy catheter designed to remove the blockage while avoiding the disruption of normal arterial wall structures. This lumivascular ...
HeartWare International has received the U.S. Food and Drug Administration (FDA) approval to enroll supplemental patient cohort for ENDURANCE, a pivotal destination therapy clinical study. HeartWare will enroll up to 286 patients ...
Spinal Modulation has enrolled the first patient in ACCURATE study, a prospective, randomized, multi-center, controlled trial designed to evaluate the safety and efficacy of the Axium neurostimulator system for the treatment of chronic ...
Tags: Spinal Modulation, treatment
Australia-based Allied Healthcare Group has received CE mark approval for its lead regenerative product called CardioCel, which is used in treating congenital heart disease and repairing heart valves. The approval will help the company to ...
Tags: Cardiocel, CE Mark Approval
Reverse Medical has received the 510(k) clearance from the US Food and Drug Administration (FDA) for its MVP Micro Vascular Plug system, which is designed for peripheral artery embolization. MVP Micro Vascular Plug system is used to ...
Tags: Reverse Medical, Medicine
TUV SUD America, a testing, inspection and certification organization, has completed its stage 2 ISO 13485 audit with Solos Endoscopy on August 16, 2013. Solos Endoscopy will be certified to ISO 13485:2003, the internationally-recognized ...
Tags: Solos Endoscopy, ISO 13485
Many column inches have been devoted to CE Marking in recent months in the advent of the mandatory July 1st deadline. But proof that there are still many companies requiring help for compliance is demonstrated in the number of ...
Tags: Construction, Decoration, CE Marking
Irvine Scientific, a provider of assisted reproductive technologies (ART), has received CE Mark for its Continuous Single Culture (CSCM) and Continuous Single Culture Complete (CSCM-C) products. Both CSCM and CSCM-C (containing Human ...
Tags: Irvine Scientific, CE Mark