CE Mark Approval

In a press release issued last friday the French Medical Devices Industry Association (SNITEM) is keen to avoid stigmatising French medtech industry controls as being unduly lax, in view of the PIP scandal.

First and only 4-mm thrombectomy devices that can be deployed through catheters as small as 10/14 offer improved navigation and aspiration.

Smith & Nephew plc has followed last year’s launch of PICO in Europe, Canada, and Australia by announcing that its pocket-sized PICO single use Negative Pressure Wound Therapy (NPWT) system has now received FDA clearance.

California-based Biomerix Corporation has announced that it has received CE Mark approval for its ASSURE soft tissue repair mesh.

Texas based AirStrip Technologies, Inc. has received CE Mark certification to market its innovative mobile patient monitoring applications in the European Community as well as other international territories outside Europe.

US ophthalmologic imaging technology company Bioptigen Inc., has received regulatory approval to market its hand-held Envisu C2000-series systems for clinical use within the European Union

Covidien extends the functionality of its Nellcor respiratory monitoring platform with CE Mark approval for its Nellcor™ Respiration Rate Version 1.0 Software and the Adult Respiration Rate Sensor.

SonoSite, Inc.has received CE Mark approval to market its next generation point-of-care product: EDGE™ ultrasound system in the European Union.

California-based Magnetecs Corporation has reported that the company’s Robotic Catheter Guidance Control and Imaging™ (CGCI) System has received CE Marking certification.

First Single-Platform Femtosecond Laser Now Commercially Available in European Union

Sorin Group has received CE Mark approval for INSPIRE™6, the first model of an entire new family of oxygenator systems bringing improved performance and flexibility during cardiopulmonary bypass procedures in adult patients.

Rayner Intraocular Lenses Limited, the world’s original manufacturer of IOLs, has received CE Mark approval for the Sulcoflex® Multifocal Toric IOL.

UK Medtech company Cellnovo ticks all the boxes in remote diabetes management.

Medtech Business has reported that a cardiac pacing system designed for safe use during magnetic resonance imaging (MRI) scans has been implanted in UK patients for the first time.

New MRI Compatible Lumax 740 series ICDs with ProMRI® offer extended longevity and BIOTRONIK Home Monitoring® for improved patient care.

Neovasc Inc. has announced that it has received the CE mark designation for its Reducer™ product for the treatment of refractory angina.