Medical Device Network-Updates The latest content updates from the www.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 FDA grants approval for ZELTIQ to conduct CoolSculpting procedure at lower temperatures http://www.medicaldevice-network.com/news/newszeltiq-coolsculpting-procedure-4500553 http://www.medicaldevice-network.com/news/newszeltiq-coolsculpting-procedure-4500553 US Food and Drug Administration (FDA) has granted clearance for ZELTIQ Aesthetics to carry out a CoolSculpting procedure at lower temperatures, which will help reduce treatment times. Fri, 30 Jan 2015 00:00:00 GMT FDA approves DePuy Synthes' Synapse OCT system with posterior cervical screws http://www.medicaldevice-network.com/news/newsdepuy-synthes-synapse-oct-system-4500747 http://www.medicaldevice-network.com/news/newsdepuy-synthes-synapse-oct-system-4500747 US Food and Drug Administration (FDA) has granted 510(k) clearance to market DePuy Synthes' Spine Synapse Occipital-Cervical-Thoracic (OCT) System with posterior cervical screws. Fri, 30 Jan 2015 00:00:00 GMT FDA approves St Jude Medical’s FlexAbility Ablation Catheter http://www.medicaldevice-network.com/news/newsst-jude-medical-catheter-4499036 http://www.medicaldevice-network.com/news/newsst-jude-medical-catheter-4499036 US Food and Drug Administration (FDA) has granted approval for St Jude Medical's FlexAbility Ablation Catheter, a new ablation technology used by electrophysiologists to treat cardiac arrhythmias. Thu, 29 Jan 2015 00:00:00 GMT Agilent gets Chinese approval for SureScan Dx microarray scanner http://www.medicaldevice-network.com/news/newsagilent-surescan-dx-4498427 http://www.medicaldevice-network.com/news/newsagilent-surescan-dx-4498427 US-based Agilent Technologies has received approval from China Food and Drug Administration for its SureScan Dx microarray scanner, as a medical device for in-vitro diagnostic use. Wed, 28 Jan 2015 00:00:00 GMT Roche's cobas MRSA / SA Test secures FDA 510(k) clearance http://www.medicaldevice-network.com/news/newsroche-cobas-mrsa-test-4497349 http://www.medicaldevice-network.com/news/newsroche-cobas-mrsa-test-4497349 Roche has received 510(k) clearance from US Food and Drug Administration (FDA) for its cobas MRSA / SA Test for early and simultaneous detection of methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-sensitive Staphylococcus aureus (SA… Wed, 28 Jan 2015 00:00:00 GMT FDA approves Dexcom G4 platinum system http://www.medicaldevice-network.com/news/newsfda-approves-dexcom-g4-platinum-system-4497311 http://www.medicaldevice-network.com/news/newsfda-approves-dexcom-g4-platinum-system-4497311 The US Food and Drug Administration (FDA) has granted approval for Dexcom's G4 platinum continuous glucose monitoring system with share receiver. Tue, 27 Jan 2015 00:00:00 GMT AliveCor secures CE Mark on atrial fibrillation algorithm for UK and Ireland http://www.medicaldevice-network.com/news/newsalivecor-secures-ce-mark-atrial-fibrillation-algorithm-uk-ireland-4495923 http://www.medicaldevice-network.com/news/newsalivecor-secures-ce-mark-atrial-fibrillation-algorithm-uk-ireland-4495923 US-based innovator in mobile technology for heart health AliveCor has secured CE Mark clearance for its automated analysis process (algorithm) to detect atrial fibrillation (AF), the most common cause of a stroke. Mon, 26 Jan 2015 00:00:00 GMT LifeScan launches OneTouch Verio Blood Glucose Monitoring System http://www.medicaldevice-network.com/news/newslifescan-onetouch-verio-4495824 http://www.medicaldevice-network.com/news/newslifescan-onetouch-verio-4495824 US-based maker of blood glucose monitoring systems LifeScan has launched its new OneTouch Verio Blood Glucose Monitoring System, which enables diabetes patients to easily understand their results. Fri, 23 Jan 2015 00:00:00 GMT Ventana Medical seeks premarket approval from FDA for ALK (D5F3) CDx assay http://www.medicaldevice-network.com/news/newsventana-medical-alk-4495835 http://www.medicaldevice-network.com/news/newsventana-medical-alk-4495835 Roche Group member Ventana Medical Systems has submitted an application to US Food and Drug Administration (FDA) seeking premarket approval (PMA) for the Ventana ALK (D5F3) companion diagnostic (CDx) assay. Fri, 23 Jan 2015 00:00:00 GMT Alex Wagteveld Appointed to Lead Multisorb's Commercial Efforts in Northern Europe http://www.medicaldevice-network.com/contractors/packaging/multisorbtechnologies/pressalex-wagteveld-multisorb.html http://www.medicaldevice-network.com/contractors/packaging/multisorbtechnologies/pressalex-wagteveld-multisorb.html Multisorb Technologies is proud to announce the appointment of Mr Alex Jan Wagteveld to the position of business development leader, Northern Europe, Healthcare Packaging, as part of its global expansion. Thu, 22 Jan 2015 15:47:00 GMT Delivering Precision with CompactCell http://www.medicaldevice-network.com/downloads/whitepapers/sterilisation/precision-compactcell/ http://www.medicaldevice-network.com/downloads/whitepapers/sterilisation/precision-compactcell/ Precision is critical when a product's treatment specifications include a strict minimum and maximum dose range. Thu, 22 Jan 2015 10:57:00 GMT FDA grants 510(k) clearance for Hospira's Plum 360 infusion system http://www.medicaldevice-network.com/news/newshospira-plum-360-infusion-4494618 http://www.medicaldevice-network.com/news/newshospira-plum-360-infusion-4494618 US Food and Drug Administration (FDA) has granted 510(k) clearance for Hospira's Plum 360 infusion system with Hospira MedNet safety software. Thu, 22 Jan 2015 00:00:00 GMT Micro Systems Engineering Completes Cleanroom Expansion http://www.medicaldevice-network.com/contractors/electronics/mst-group/pressmicro-systems-cleanroom-expansion.html http://www.medicaldevice-network.com/contractors/electronics/mst-group/pressmicro-systems-cleanroom-expansion.html Micro Systems Engineering has expanded its existing cleanroom capacity with a state-of-the-art cleanroom, bringing the total cleanroom area to 20,000ft². Wed, 21 Jan 2015 15:18:00 GMT FDA grants PMA-Supplement approval for Flowonix Medical's Prometra II system http://www.medicaldevice-network.com/news/newsflowonix-medical-prometra-ii-4493720 http://www.medicaldevice-network.com/news/newsflowonix-medical-prometra-ii-4493720 The US Food and Drug Administration (FDA) has granted PMA-Supplement approval for Flowonix Medical's intrathecal infusion device, the Prometra II system. Wed, 21 Jan 2015 00:00:00 GMT NEC Display gets FDA 510(K) clearance for MD210C3 diagnostic monitor http://www.medicaldevice-network.com/news/newsnec-diagnostic-monitor-4493579 http://www.medicaldevice-network.com/news/newsnec-diagnostic-monitor-4493579 NEC Display Solutions of America has received 510(K) market clearance from US Food and Drug Administration (FDA) for the MultiSync MD210C3 LCD, a cost-effective display with LED backlighting for diagnostic applications in healthcare organisations. Wed, 21 Jan 2015 00:00:00 GMT FDA grants 510(k) approval for ECA Medical's disposable spine implant fixation kit http://www.medicaldevice-network.com/news/newsfda-grants-510k-approval-eca-medicals-disposable-spine-implant-fixation-kit-4492478 http://www.medicaldevice-network.com/news/newsfda-grants-510k-approval-eca-medicals-disposable-spine-implant-fixation-kit-4492478 The US Food and Drug Administration (FDA) has granted 510(k) approval for ECA Medical Instruments' newly developed fully disposable spine implant fixation instrument kit. Tue, 20 Jan 2015 00:00:00 GMT Zyno gets CE Mark for Z-800 Infusion system and administration sets http://www.medicaldevice-network.com/news/newszyno-z-800-infusion-system-4491293 http://www.medicaldevice-network.com/news/newszyno-z-800-infusion-system-4491293 Zyno Medical has received European CE Mark approval for its Z-800 Infusion system including models Z-800, Z-800F, Z-800W and Z-800WF, and Zyno administration sets. Mon, 19 Jan 2015 00:00:00 GMT Alphaeon and Tracey to market iTrace platform http://www.medicaldevice-network.com/news/newsalphaeon-tracey-itrace-4491323 http://www.medicaldevice-network.com/news/newsalphaeon-tracey-itrace-4491323 US-based Strathspey Crown Holdings' subsidiary Alphaeon has signed a co-promotion agreement with Tracey Technologies to market next-generation iTrace platform. Mon, 19 Jan 2015 00:00:00 GMT Polyurethane Foams: What Can Our Product Do For You? http://www.medicaldevice-network.com/contractors/adhesives/exopack-advanced-coatings/presspolyurethane-foams-coveris.html http://www.medicaldevice-network.com/contractors/adhesives/exopack-advanced-coatings/presspolyurethane-foams-coveris.html Polyurethane foams from Coveris Advanced Coatings are part of the company's inspire® medical portfolio. Fri, 16 Jan 2015 16:08:00 GMT Gateway to Innovation: SteriPro® Labs http://www.medicaldevice-network.com/downloads/whitepapers/sterilisation/steripro-labs/ http://www.medicaldevice-network.com/downloads/whitepapers/sterilisation/steripro-labs/ Sterigenics's SteriPro labs provide comprehensive test services to help customers optimise processing and bring their products to market in a quick and cost-effective manner. Fri, 16 Jan 2015 12:45:00 GMT