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
WEB Biotechnology, a Singapore based medical technology company, has received CE certification for its cloud-based continuous ECG monitor called the Spyder. It is claimed to the first cloud-based continuous ECG monitor available in the ...
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
US-based BioFire Diagnostics has begun clinical and analytical studies to evaluate its FilmArray Gastrointestinal (GI) Panel. This clinical study is being conducted at several hospital-based clinical laboratories in the US and is funded ...
The Precision Fluidics Division of Parker Hannifin Corporation, the global leader in motion and control technologies, announces the release of the Parker Smart Syringe Pump, a 30mm syringe pump that improves the performance of Clinical ...
Tags: Syringe Pump, control technologies
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
Tenex Health, a medical device maker, has secured CE Marking for its TX System, which can be c. Tenex Health founder and CEO Jagi Gill said that the TX System has enjoyed tremendous clinical and commercial success in the US since its ...
Tags: Tenex Health, medical device
Hologic's Aptima HPV assay has received clearance from the US Food and Drug Administration (FDA) for use on its fully-automated Panther system, enabling laboratories to run multiple tests from a single specimen. A nucleic acid amplified ...
Tags: Panther System, Aptima HPV Assay
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