Medical Device Network-Updates The latest content updates from the medicaldevice-network.com web site http://www.medicaldevice-network.com/ en-us http://www.medicaldevice-network.com/ Medical Device Network-Updates http://www.medicaldevice-network.com/content/images/logo_big.gif Medtronic implants first patient with Evera MRI ICD system in US http://www.medicaldevice-network.com/news/newsmedtronic-implants-first-patient-with-evera-mri-icd-system-in-us-4218731 http://www.medicaldevice-network.com/news/newsmedtronic-implants-first-patient-with-evera-mri-icd-system-in-us-4218731 Medtronic has reported the first US implant of the Evera MRI SureScan implantable cardioverter-defibrillator (ICD) system, following Food and Drug Administration (FDA) approval for its investigational device exemption (IDE) application and pivotal cl… Wed, 23 Apr 2014 05:30:00 GMT USFDA proposes new programme for expediting access to high-risk medical devices http://www.medicaldevice-network.com/news/newsusfda-proposes-new-programme-for-expediting-access-to-high-risk-medical-devices-4218651 http://www.medicaldevice-network.com/news/newsusfda-proposes-new-programme-for-expediting-access-to-high-risk-medical-devices-4218651 The US Food and Drug Administration (FDA) has proposed a new programme to speed up access to high-risk medical devices for addressing medical needs that are unmet by current technology. Wed, 23 Apr 2014 05:30:00 GMT Federal court postpones injunction on Medtronic's CoreValve system in US http://www.medicaldevice-network.com/news/newsfederal-court-postpones-injunction-on-medtronics-corevalve-system-in-us-4217727 http://www.medicaldevice-network.com/news/newsfederal-court-postpones-injunction-on-medtronics-corevalve-system-in-us-4217727 The Federal Circuit Court of Appeals has granted a request from Medtronic to suspend the preliminary injunction that was ordered on 11 April to limit the sale of its CoreValve system in the US. Tue, 22 Apr 2014 05:30:00 GMT EndoStim gets CE Mark for MRI-safe LES stimulation system http://www.medicaldevice-network.com/news/newsendostim-gets-ce-mark-for-mri-safe-les-stimulation-system-4217527 http://www.medicaldevice-network.com/news/newsendostim-gets-ce-mark-for-mri-safe-les-stimulation-system-4217527 US-based EndoStim has obtained CE Mark approval for its lower esophageal sphincter (LES) stimulation system to use with magnetic resonance imaging (MRI). Tue, 22 Apr 2014 05:30:00 GMT Boston Scientific obtains FDA approval for new defibrillators, heart failure devices http://www.medicaldevice-network.com/news/newsboston-scientific-obtains-fda-approval-new-defibrillators-heart-failure-devices-4215527 http://www.medicaldevice-network.com/news/newsboston-scientific-obtains-fda-approval-new-defibrillators-heart-failure-devices-4215527 Boston Scientific has obtained US Food and Drug Administration (FDA) approval for its latest generation of defibrillators and heart failure devices designed to advance patient care. Thu, 17 Apr 2014 05:30:00 GMT US military approves MedTrade’s Celox gauze bandage to save lives on battlefield http://www.medicaldevice-network.com/news/newsus-military-approves-medtrades-celox-gauze-bandage-to-save-lives-on-battlefield-4215907 http://www.medicaldevice-network.com/news/newsus-military-approves-medtrades-celox-gauze-bandage-to-save-lives-on-battlefield-4215907 The US military has approved UK-based MedTrade‘s Celox gauze bandage, designed to stop severe arterial bleeding in three minutes and save soldiers' lives on the battlefield. Thu, 17 Apr 2014 05:30:00 GMT Medicrea launches first patient-specific spinal rod system in Europe http://www.medicaldevice-network.com/news/newsmedicrea-launches-first-patient-specific-spinal-rod-system-in-europe-4214686 http://www.medicaldevice-network.com/news/newsmedicrea-launches-first-patient-specific-spinal-rod-system-in-europe-4214686 Surgical technologies developer the Medicrea group has launched the UNiD, the world's first patient-specific spinal osteosynthesis rod system in Europe. Wed, 16 Apr 2014 05:30:00 GMT Abbott wins FDA clearance for ARCHITECT clinical chemistry haemoglobin A1c test http://www.medicaldevice-network.com/news/newsabbott-wins-fda-clearance-for-architect-clinical-chemistry-haemoglobin-a1c-test-4215032 http://www.medicaldevice-network.com/news/newsabbott-wins-fda-clearance-for-architect-clinical-chemistry-haemoglobin-a1c-test-4215032 Abbott has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new ARCHITECT clinical chemistry haemoglobin A1c (HbA1c) test, designed to aid physicians in diagnosing and monitoring diabetes and identifying people at risk… Wed, 16 Apr 2014 05:30:00 GMT ROX Medical completes enrolment in device mediated blood pressure therapy study http://www.medicaldevice-network.com/news/newsrox-medical-completes-enrolment-in-device-mediated-blood-pressure-therapy-study-4214245 http://www.medicaldevice-network.com/news/newsrox-medical-completes-enrolment-in-device-mediated-blood-pressure-therapy-study-4214245 US-based ROX Medical has completed the patient enrollment in CONTROL-HTN trial, an international multi-centre, prospective, randomised, controlled, blinded endpoint trial designed to assess ROX Coupler in patients with arterial hypertension. Tue, 15 Apr 2014 05:30:00 GMT Covidien gets USFDA clearance for camera-equipped feeding tube with IRIS technology http://www.medicaldevice-network.com/news/newscovidien-gets-usfda-clearance-for-camera-equipped-feeding-tube-with-iris-technology-4214479 http://www.medicaldevice-network.com/news/newscovidien-gets-usfda-clearance-for-camera-equipped-feeding-tube-with-iris-technology-4214479 Medical devices manufacturer Covidien has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Kangaroo feeding tube with integrated real-time imaging system (IRIS) technology. Tue, 15 Apr 2014 05:30:00 GMT Edwards Lifesciences wins US sales injunction against Medtronic's CoreValve system http://www.medicaldevice-network.com/news/newsedwards-lifesciences-wins-us-sales-injunction-against-medtronics-corevalve-system-4213810 http://www.medicaldevice-network.com/news/newsedwards-lifesciences-wins-us-sales-injunction-against-medtronics-corevalve-system-4213810 Edwards Lifesciences has obtained a preliminary injunction from the Federal District Court of Delaware to prevent Medtronic from selling its CoreValve transcatheter aortic valve implantation system in the US. Mon, 14 Apr 2014 05:30:00 GMT Covidien recalls certain lots of Pipeline and Alligator cerebral aneurysm devices http://www.medicaldevice-network.com/news/newscovidien-recalls-certain-lots-of-pipeline-alligator-cerebral-aneurysm-devices-4213892 http://www.medicaldevice-network.com/news/newscovidien-recalls-certain-lots-of-pipeline-alligator-cerebral-aneurysm-devices-4213892 Irish firm Covidien has recalled certain lots of its two cerebral aneurysm medical devices, citing risk of stroke or death in patients caused by potential delamination of the polytetrafluoroethylene (PTFE) coating applied to the delivery wire. Mon, 14 Apr 2014 05:30:00 GMT Rhenus Advanced Services Successfully Operates as the 'Order to Cash' Provider for Nonin Medical, Inc. http://www.medicaldevice-network.com/contractors/distribution/rhenus-logistics/pressorder-to-cash-provider.html http://www.medicaldevice-network.com/contractors/distribution/rhenus-logistics/pressorder-to-cash-provider.html Rhenus Advanced Services in Tilburg, the Netherlands has now been working for Nonin Medical, a global leader in non-invasive medical monitoring equipment, for the past year; it serves its distributors in Europe, the Middle East, Africa and on the Ind… Fri, 11 Apr 2014 17:29:00 GMT Medtronic’s Evera MRI SureScan ICD system gets CE Mark http://www.medicaldevice-network.com/news/newsmedtronics-evera-mri-surescan-icd-system-gets-ce-mark-4212415 http://www.medicaldevice-network.com/news/newsmedtronics-evera-mri-surescan-icd-system-gets-ce-mark-4212415 Medtronic has obtained CE Mark approval for its Evera MRI SureScan, an implantable cardioverter-defibrillator (ICD) system designed to allow for full-body MRI scans positioned on any region of the body. Thu, 10 Apr 2014 23:00:00 GMT FDA approves Baxano’s Avance minimally invasive pedicle screw system http://www.medicaldevice-network.com/news/newsfda-approves-baxano-surgicals-avance-minimally-invasive-pedicle-screw-system-4212605 http://www.medicaldevice-network.com/news/newsfda-approves-baxano-surgicals-avance-minimally-invasive-pedicle-screw-system-4212605 Baxano Surgical has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Avance minimally invasive pedicle screw system. Thu, 10 Apr 2014 23:00:00 GMT FDA approves Analogic’s handheld Sonic Window ultrasound system http://www.medicaldevice-network.com/news/newsfda-approves-analogics-sonic-window-ultrasound-system-4212088 http://www.medicaldevice-network.com/news/newsfda-approves-analogics-sonic-window-ultrasound-system-4212088 US-based Analogic has obtained US Food and Drug Administration (FDA) 510(k) approval for its Sonic Window ultrasound system, a handheld ultra-compact imaging device for visualising vasculature and guiding peripheral intravenous access. Wed, 09 Apr 2014 23:00:00 GMT FDA approves Ortho Development’s Ovation Tribute hip stem http://www.medicaldevice-network.com/news/newsfda-approves-ortho-developments-ovation-tribute-hip-stem-4212077 http://www.medicaldevice-network.com/news/newsfda-approves-ortho-developments-ovation-tribute-hip-stem-4212077 Ortho Development has obtained approval from the US Food and Drug Administration (FDA) for its Ovation Tribute hip stem that is intended for cementless use in total hip replacement and hemiarthroplasty procedures. Wed, 09 Apr 2014 23:00:00 GMT Zimmer Spine announces US launch of Optio-C anterior cervical system http://www.medicaldevice-network.com/news/newszimmer-spine-announces-us-launch-of-optio-c-anterior-cervical-system-4211110 http://www.medicaldevice-network.com/news/newszimmer-spine-announces-us-launch-of-optio-c-anterior-cervical-system-4211110 Zimmer Spine has announced the launch of its next-generation Optio-C anterior cervical system in the US. Wed, 09 Apr 2014 05:30:00 GMT FDA approves GE Healthcare’s Q.Clear technology http://www.medicaldevice-network.com/news/newsfda-approves-ge-healthcares-qclear-technology-4211297 http://www.medicaldevice-network.com/news/newsfda-approves-ge-healthcares-qclear-technology-4211297 GE Healthcare has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Q.Clear technology that can provide up to two times improvement in both quantitative accuracy and image quality in positron emission tomography (PET)/co… Tue, 08 Apr 2014 23:00:00 GMT March’s top stories: Baxter to split, first migraine device gets FDA clearance http://www.medicaldevice-network.com/features/featuremarchs-top-stories-baxter-to-split-first-migraine-device-gets-fda-clearance-4206005/ http://www.medicaldevice-network.com/features/featuremarchs-top-stories-baxter-to-split-first-migraine-device-gets-fda-clearance-4206005/ Baxter revealed its plans to split itself into two separate and independent entities, while Cefaly Technology obtained FDA clearance for its device for preventative treatment of migraine headaches. Medicaldevice-network.com wraps-up the key headlines… Tue, 08 Apr 2014 08:50:00 GMT