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 CVRx's Barostim neo system gets CE Mark approval for heart failure treatment http://www.medicaldevice-network.com/news/newscvrxs-barostim-neo-system-gets-ce-mark-approval-heart-failure-treatment-4390030 http://www.medicaldevice-network.com/news/newscvrxs-barostim-neo-system-gets-ce-mark-approval-heart-failure-treatment-4390030 US-based medical device firm CVRx has received CE Mark approval from the National Standards Authority of Ireland (NSAI) for the Barostim neo system to treat heart failure patients. Mon, 29 Sep 2014 23:00:00 GMT EnteroMedics' CE Mark for Maestro RC system now includes type 2 diabetes treatment http://www.medicaldevice-network.com/news/newsenteromedics-ce-mark-maestro-rc-system-includes-type-2-diabetes-treatment-4390131 http://www.medicaldevice-network.com/news/newsenteromedics-ce-mark-maestro-rc-system-includes-type-2-diabetes-treatment-4390131 US-based EnteroMedics' CE Mark for the Maestro Rechargeable (RC) system for obesity has been expanded to include the management of type 2 diabetes mellitus through improved glycemic control. Mon, 29 Sep 2014 23:00:00 GMT Thermo Fisher, GSK and Pfizer partner for new NGS oncology test http://www.medicaldevice-network.com/news/newsthermo-fisher-gsk-and-pfizer-partner-for-new-ngs-oncology-test-4388206 http://www.medicaldevice-network.com/news/newsthermo-fisher-gsk-and-pfizer-partner-for-new-ngs-oncology-test-4388206 Thermo Fisher Scientific has entered into partnership with GlaxoSmithKline (GSK) and Pfizer to develop a universal next-generation sequencing (NGS) oncology test for solid tumours, which can be used as a companion diagnostic for multiple drug program… Sun, 28 Sep 2014 23:00:00 GMT Aethlon, Boston University CTE Center partner to advance blood-based diagnostic candidate http://www.medicaldevice-network.com/news/newsaethlon-boston-university-cte-center-partner-to-advance-blood-based-diagnostic-candidate-4388329 http://www.medicaldevice-network.com/news/newsaethlon-boston-university-cte-center-partner-to-advance-blood-based-diagnostic-candidate-4388329 Aethlon Medical and its diagnostic subsidiary Exosome Sciences (ESI) have entered into a clinical collaboration with the Boston University (BU) CTE Center to advance a blood-based diagnostic candidate to detect chronic traumatic encephalopathy (CTE).… Sun, 28 Sep 2014 23:00:00 GMT FDA grants 510(k) clearance for Unisense FertiliTech's EmbryoViewer software http://www.medicaldevice-network.com/news/newsfda-grants-510k-clearance--unisense-fertilitechs-embryoviewer-software-4386851 http://www.medicaldevice-network.com/news/newsfda-grants-510k-clearance--unisense-fertilitechs-embryoviewer-software-4386851 The US Food and Drug Administration has granted 510(k) clearance for Unisense FertiliTech's Compare & Select feature in the EmbryoViewer software, an accessory in the EmbryoScope time-lapse incubator. Thu, 25 Sep 2014 23:00:00 GMT Roche introduces global access programme to combat AIDS, TB and malaria http://www.medicaldevice-network.com/news/newsroche-introduces-global-access-programme-to-combat-aids-tb-and-malaria-4386774 http://www.medicaldevice-network.com/news/newsroche-introduces-global-access-programme-to-combat-aids-tb-and-malaria-4386774 Swiss global health-care firm Roche has launched a global access programme for HIV viral load testing to combat AIDS, tuberculosis (TB) and malaria. Thu, 25 Sep 2014 23:00:00 GMT Remote Diagnostic's Tempus Pro medical monitor gets FDA 510(k) clearance http://www.medicaldevice-network.com/news/newsremote-diagnostics-tempus-pro-medical-monitor-gets-fda-510k-clearance-4385170 http://www.medicaldevice-network.com/news/newsremote-diagnostics-tempus-pro-medical-monitor-gets-fda-510k-clearance-4385170 UK-based Remote Diagnostic Technologies (RTD) has received 510(k) clearance from the US Food and Drug Administration for its Tempus Pro medical monitor. Wed, 24 Sep 2014 23:00:00 GMT Terumo to distribute Nonin's SenSmart oximetry system in US http://www.medicaldevice-network.com/news/newsterumo-to-distribute-nonins-sensmart-oximetry-system-in-us-4385224 http://www.medicaldevice-network.com/news/newsterumo-to-distribute-nonins-sensmart-oximetry-system-in-us-4385224 US-based Terumo Cardiovascular Group is set to distribute Nonin Medical's SenSmart Model X-100 Universal Oximetry System to adult and paediatric cardiovascular hospitals in the US. Wed, 24 Sep 2014 23:00:00 GMT GE Healthcare’s Discovery IQ system receives 510(k) clearance from FDA http://www.medicaldevice-network.com/news/newsge-healthcares-discovery-iq-system-receives-510k-clearance-fda-4383388 http://www.medicaldevice-network.com/news/newsge-healthcares-discovery-iq-system-receives-510k-clearance-fda-4383388 The US Food and Drug Administration (FDA) has granted 510(k) clearance for GE Healthcare's Discovery IQ PET/CT system. Tue, 23 Sep 2014 23:00:00 GMT Boston Scientific begins REPRISE III trial of Lotus Valve System http://www.medicaldevice-network.com/news/newsboston-scientific-begins-reprise-iii-trial-lotus-valve-system-4383368 http://www.medicaldevice-network.com/news/newsboston-scientific-begins-reprise-iii-trial-lotus-valve-system-4383368 US-based Boston Scientific has started a REPRISE III clinical trial designed to assess the safety and effectiveness of the Lotus Valve System in patients with severe aortic stenosis. Tue, 23 Sep 2014 23:00:00 GMT 4WEB Medical launches new Osteotomy Truss System http://www.medicaldevice-network.com/news/news4web-medical-launches-new-osteotomy-truss-system-4382121 http://www.medicaldevice-network.com/news/news4web-medical-launches-new-osteotomy-truss-system-4382121 US-based implant device firm 4WEB Medical has launched a new Osteotomy Truss System, which meets a surgeon's osteotomy needs with 74 size options of foot and ankle implants. Mon, 22 Sep 2014 23:00:00 GMT Medtronic's TYRX absorbable antibacterial envelope gets CE Mark approval http://www.medicaldevice-network.com/news/newsmedtronics-tyrx-absorbable-antibacterial-envelope-gets-ce-mark-approval-4381803 http://www.medicaldevice-network.com/news/newsmedtronics-tyrx-absorbable-antibacterial-envelope-gets-ce-mark-approval-4381803 Medtronic has secured CE Mark approval for its TYRX absorbable antibacterial envelope, which covers an implantable cardiac device and reduces surgical-site infections. Mon, 22 Sep 2014 23:00:00 GMT Covidien gets FDA 510(k) approval for Sonicision cordless ultrasonic dissection device http://www.medicaldevice-network.com/news/newscovidien-gets-fda-510k-approval-sonicision-cordless-ultrasonic-dissection-device-4380369 http://www.medicaldevice-network.com/news/newscovidien-gets-fda-510k-approval-sonicision-cordless-ultrasonic-dissection-device-4380369 Irish-based Covidien has received 510(k) approval from the US Food and Drug Administration (FDA) for its Sonicision cordless ultrasonic dissection device with three additional lengths, 13cm, 26cm and 48cm. Sun, 21 Sep 2014 23:00:00 GMT Smith & Nephew to launch D-RAD SMART PACK System to treat distal radius fractures http://www.medicaldevice-network.com/news/newssmith-nephew-launch-d-rad-smart-pack-system-treat-distal-radius-fractures-4380125 http://www.medicaldevice-network.com/news/newssmith-nephew-launch-d-rad-smart-pack-system-treat-distal-radius-fractures-4380125 UK-based Smith & Nephew is planning to launch a new D-RAD SMART PACK System for treatment of distal radius fractures. Sun, 21 Sep 2014 23:00:00 GMT Milestone Scientific's CompuFlo epidural injection system gets CE Mark approval http://www.medicaldevice-network.com/news/newsmilestone-scientifics-compuflo-epidural-injection-system-gets-ce-mark-approval-4378848 http://www.medicaldevice-network.com/news/newsmilestone-scientifics-compuflo-epidural-injection-system-gets-ce-mark-approval-4378848 US-based Milestone Scientific's (MLSS) subsidiary Milestone Medical has secured CE Mark to market and sell its epidural injection system the CompuFlo Epidural Computer Controlled Anesthesia System (CompuFlo Epidural Model 6000) in Europe. Thu, 18 Sep 2014 23:00:00 GMT Roche launches new fertility test for ovarian reserve assessment http://www.medicaldevice-network.com/news/newsroche-launches-new-fertility-test-for-ovarian-reserve-assessment-4378913 http://www.medicaldevice-network.com/news/newsroche-launches-new-fertility-test-for-ovarian-reserve-assessment-4378913 Switzerland-based Roche has launched the new elecsys anti-müllerian hormone (AMH) blood test, the first fully automated AMH method designed to evaluate a woman's ovarian reserve. Thu, 18 Sep 2014 23:00:00 GMT Boston Scientific's Vercise DBS system gets CE Mark to treat tremor patients http://www.medicaldevice-network.com/news/newsboston-scientifics-vercise-dbs-system-gets-ce-mark-to-treat-tremor-patients-4377667 http://www.medicaldevice-network.com/news/newsboston-scientifics-vercise-dbs-system-gets-ce-mark-to-treat-tremor-patients-4377667 US-based Boston Scientific has secured CE Mark for the Vercise Deep Brain Stimulation (DBS) System to treat tremors, including the most common form of this movement disorder known as essential tremor (ET). Wed, 17 Sep 2014 23:00:00 GMT NxStage’s haemodialysis system receives FDA clearance http://www.medicaldevice-network.com/news/newsnxstages-haemodialysis-system-receives-fda-clearance-4376162 http://www.medicaldevice-network.com/news/newsnxstages-haemodialysis-system-receives-fda-clearance-4376162 NxStage Medical has received the US Food and Drug Administration clearance for its single needle technology haemodialysis system, OneSite. Wed, 17 Sep 2014 23:00:00 GMT Medtronic launches SEEQ mobile cardiac telemetry system in US http://www.medicaldevice-network.com/news/newsmedtronic-launches-seeq-mobile-cardiac-telemetry-system-in-us-4374873 http://www.medicaldevice-network.com/news/newsmedtronic-launches-seeq-mobile-cardiac-telemetry-system-in-us-4374873 Medtronic has launched a new external wire-free, adhesive heart monitor SEEQ mobile cardiac telemetry (MCT) system, designed to help patients find answers to unexplained cardiac symptoms. Tue, 16 Sep 2014 23:00:00 GMT Roche launches Accu-Chek Aviva expert system for diabetic patients http://www.medicaldevice-network.com/news/newsroche-launches-accu-chek-aviva-expert-system-diabetic-patients-4375669 http://www.medicaldevice-network.com/news/newsroche-launches-accu-chek-aviva-expert-system-diabetic-patients-4375669 Swiss drugmaker Roche has announced that its blood glucose meter system, Accu-Chek Aviva expert system, has received an approval of the US food and drug administration (FDA) will now be available by prescription. Tue, 16 Sep 2014 23:00:00 GMT