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
As one of the largest LED lighting manufacturers and exporters, Spark just made its another achievement on the installation of LED street light SPL-C115 in Uthaithani Province,Thailand. This project is for a very famous temple in ...
Tags: LED Street Light, Lighting
US- based St. Jude Medical has acquired Endosense, a Switzerland-based company for a purchase price of $170m (CHF159m) up-front plus the potential for up to $161m (CHF150m) in subsequent milestone payments. While the acquisition is ...
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
Medtronic has submitted its first pre-market approval (PMA) module to the U.S. Food and Drug Administration (FDA) for the IN.PACT Admiral drug-eluting balloon designed to treat atherosclerotic lesions in the superficial femoral artery ...
Tags: Medtronic, Admiral Drug-Eluting
Pathogenica has received the CE mark for its HAI BioDetection kit that runs on the Ion PGM benchtop sequencer. HAI BioDetection CE-IVD kit is a qualitative in vitro test designed for the rapid identification of bacterial organisms and ...
Tags: Pathogenica, CE Mark
Glass Technology Services Ltd (GTS) has achieved Notified Testing Laboratory status for CE Marking glass construction products. The independent testing specialist is one of only a few providers in this sector to hold the accreditation, ...
Tags: Glass, Construction, CE marking
Dialight, the innovative global leader in LED lighting technology, yesterday announced its innovation program has gained UL certification and CE compliance for its DuroSite® LED High Bay and Low Bay product portfolios for industrial ...
Dialight, the innovative global leader in LED lighting technology, recently launched the first-ever Class I Div. 2 certified 25,000 lumen SafeSite LED High Bay, with a 10-year warranty. The high output LED High Bay offers superior ...
Tags: Dialight