Medical Product Guide» CE Mark

Medtronic Gains Ce Mark For Enhanced Corevalve(R) Delivery Catheter System With Accutrak Stability Layer

Jim Marino — Fri, 10 Sep 2010 05:25:09 +0000

Medtronic, Inc. announced CE Mark approval and the first global use and launch of the Medtronic CoreValve® delivery system with AccuTrak™ Stability Layer for transcatheter aortic valve implantation (TAVI). AccuTrak’s proprietary technology allows physicians to achieve enhanced control and accuracy in the deployment of the CoreValv device. CoreValve and AccuTrak are not yet available in the United States, Canada or Japan for investigational or commercial sale or use.

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AdvanDx Launches GNR Traffic Light(TM) PNA FISH(R) In Europe

Jim Marino — Thu, 19 Aug 2010 08:20:53 +0000

AdvanDx announced the launch of its CE-IVD marked GNR Traffic Light™ PNA FISH® test in Europe. GNR Traffic Light PNA FISH is the first-ever test capable of simultaneously identifying Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa directly from positive blood cultures in less than 90 minutes. The GNR Traffic Light is the latest addition to AdvanDx’s easy-to-use, molecular-based PNA FISH diagnostics platform designed to provide rapid, therapy-guiding results.

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Platinum-based coronary stent awarded CE Mark

Jim Marino — Mon, 07 Dec 2009 15:12:46 +0000

A new platinum-based stent, designed by Boston Scientific, has received its CE Mark and will now be available in the relevant countries. The PROMUS Element Everolimus-Eluting Coronary Stent System was granted approval by the Dutch notified body KEMA Quality BV. In addition to featuring a platinum chromium alloy designed specifically for coronary stenting, the system has an innovative stent structure and an impressive catheter delivery mechanism.

CleveMed Receives ISO 13485, CE Mark, Canadian Certificate Approval

admin — Mon, 23 Nov 2009 11:16:42 +0000

CleveMed has received ISO 13485 certification issued by BSI Management Systems America Inc. CleveMed has also received the CE Mark and CMDCAS allowing its products to be distributed to the large European and the Canadian markets which will strengthen its worldwide market presence. CleveMed designs and manufactures a number of telemetry-based patient monitors for sleep disorders such as sleep apnea and movement disorders including Parkinson’s disease.

Intel Announces its First Home Medical Device to Better Connect Clinicians With Patients

Jim Marino — Fri, 28 Nov 2008 08:48:47 +0000

Intel Corporation has announced the Intel(R) Health Guide, a care management tool designed for healthcare professionals who treat patients with chronic conditions, for the UK. The Intel Health Guide represents Intel’s entry into a new category of personal health systems that go beyond the simple remote patient monitoring systems available today. The Intel Health Guide, a regulated device that carries the CE mark under the EU Medical Device Directive, is a comprehensive personal health system that combines an in-home patient device – the Intel Health Guide PHS6000 – as well as the Intel(R) Health Care Management Suite.

Ce Mark and FDA approval to St. Jude's Angio-Seal™ Evolution™ Vascular Closure Device

Jim Marino — Fri, 17 Oct 2008 11:04:22 +0000

The U.S. Food and Drug Administration and the European medical regulatory authority have approved St. Jude Medical, Inc.’s Angio-Seal™ Evolution™ Vascular Closure Device. The device is designed to help physicians in sealing the femoral artery punctures that take shape during minimally invasive catheter-based procedures effectively. This enables faster achievement of hemostasis (stoppage of bleeding). Featuring a completely novel delivery system, it reduces the variability occurring during deployment of the system by physicians.

Olympus to launch Spiration's IBV® Valve System

Jim Marino — Fri, 10 Oct 2008 05:47:24 +0000

Spiration, Inc. has made an announcement that its IBV® Valve System has been launched by Olympus in the European markets. The minimally invasive device is used for the treatment of various chronic lung problems. The system has already received the CE Mark for use in the treatment of serious diseases of the lung such as emphysema. Initially, the device will be presented to select physicians of Europe. The system may prove to be a boon for patients who can not or do not undergo surgical operation. Spiration® will continue with manufacturing while Olympus does the distribution.

Dilon Technologies receives CE Marking for high-resolution gamma camera

Jim Marino — Tue, 13 May 2008 16:52:49 +0000

Dilon Technologies has received CE Marking for its Dilon 6800 gamma camera. The high-resolution gamma camera enables molecular imaging of the breast and other small organs for early cancer detection. It performs breast-specific gamma imaging, a technique that images the metabolic activity of breast lesions through radiotracer uptake.

Eon Mini neurostimulator gets nod from FDA and European CE Mark

Jim Marino — Tue, 15 Apr 2008 18:15:17 +0000

St. Jude Medical Inc. has received approvals from the US Food and Drug Administration (FDA) and European CE Mark for its Eon Mini, the world’s smallest, longest-lasting, rechargeable neurostimulator to treat chronic pain of the trunk or limbs and pain from failed back surgery. The Eon Mini neurostimulator is marginally larger than the circumference of a U.S. silver dollar, has a thin 10 mm profile and weighs 29 grams (approximately 1.0 oz.). Its small size allows for a smaller incision, which gives physicians increased flexibility in selecting the implant location and is intended to make the site less visible and more comfortable for patients.

Noninvasive treatment for depression passes test

Jim Marino — Thu, 21 Feb 2008 21:27:38 +0000

Israel-based Brainsway Ltd. reported positive results from the final stage of testing its noninvasive Transcranial Magnetic Stimulation (TMS) treatment for depression. TMS is a noninvasive technique for applying brief magnetic pulses to the brain. The company said that it had obtained satisfactory results from its first efficacy test on 64 patients. Brainsway now intends to file for an application for CE Mark certification from the EU and subsequently aim for an FDA approval.