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
Symetis has announced its Acurate TA and Acurate TF TAVI systems have been successfully implanted in patients in Japan as part of a feasibility study to secure the Pharmaceutical and Device Agency's (PMDA) pre-market approval. Based on a ...
Tags: Symetis, TAVI Systems
IMRIS has obtained CE mark for its specialized multifunctional surgical theater called VISIUS iCT, designed for spinal and neurosurgical needs. Claimed to be the first ceiling-mounted intraoperative CT solution available in the market, ...
Tags: CE Mark, CT Solution
CorMatrix Cardiovascular, a US-based medical device manufacturer, has received three patents from the US Patent and Trademark Office for its biomaterial heart valve that is made from biomaterial called extracellular matrix (ECM). The ...
Tags: Matrix Heart Valve, CorMatrix
Cochlear has received CE Mark for its next generation cochlear implant sound processor Nucleus 6. Claimed to be the smallest available sound processor in the market, it is designed to provide superior outcomes for the recipient. It is ...
Tags: CE Mark, Implant Sound Processor
Cerevast Therapeutics has initiated patient enrollment in the Phase III clinical trial to evaluate the use of its Clotbust ER ultrasonic headframe for the treatment of acute ischemic stroke. The Clotbust ER Phase III clinical study is ...
Tags: Cerevast Therapeutics
Sealantis has received the CE Mark for its vascular sealant called Seal-V, a protein-free, safe, bio-compatible, and bio-resorbable vascular sealant designed for surgical reconstruction of large blood vessels such as the carotid, femoral, ...
Tags: CE Mark
Integra LifeSciences has received US regulatory clearance to market its Integra Titan Reverse Shoulder System, which offers greater flexibility for shoulder replacement surgery. The company plans to begin a limited market release in the ...
Tags: Integra Lifesciences
CryoLife has announced the first European clinical implant of its HeRO (Haemodialysis Reliable Outflow) graft following its CE Mark in June 2013. The procedure was performed at the University of Leuven Hospital in Belgium by Professor ...
Tags: CryoLife, Outflow Graft
EnteroMedics has submitted premarket approval (PMA) application to the US Food and Drug Administration (FDA) for Maestro Rechargeable System's VBLOC, a vagal blocking therapy to treat obesity. Maestro RC system delivers vagal blocking ...
Tags: EnteroMedics, Vbloc Therapy
Operations Director, Senior Architectural Systems: Since the 1st July 2013 CE Marking has become mandatory in the UK for all construction products, but what does this mean for the specifier? Mark Wadsworth, Operations Director of ...
Tags: CE Marking, Specifier
Hologic, a developer of medical imaging systems and surgical products, has received approval for its Aptima HPV assay for use on its fully-automated Panther system from the US Food and Drug Administration (FDA). The assay is a nucleic ...
Tags: Aptima HPV, Medicine
Elekta, a Sweden-based medical technology company, has received CE Mark for its Clarity 4D Monitoring system. 4D monitoring offers continuous tracking of the prostate and imaging of the surrounding anatomy, including the bladder, rectum ...
SynGen has received 510(k) approval from the US Food and Drug Administration (FDA) to market its SynGenX-1000 System, CryoPRO-2 Cryopreservation/Storage Bag Set, SynGen DataTrak software products to process cord blood. Previously, the ...
Tags: Cord Blood Processing, Syngen