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 TGAC and Optalysys partner to reduce HPC energy consumption http://www.medicaldevice-network.com/news/newstgac-optalysys-partner-reduce-hpc-energy-consumption-4521582 http://www.medicaldevice-network.com/news/newstgac-optalysys-partner-reduce-hpc-energy-consumption-4521582 The Genome Analysis Centre (TGAC) has collaborated with UK-based high performance computing (HPC) hardware provider Optalysys to develop a new optical processing device to perform large-scale DNA sequence searches for crucial genomic research. Fri, 27 Feb 2015 00:00:00 GMT Sorin and Cyberonics to create new medical technology company http://www.medicaldevice-network.com/news/newssorin-cyberonics-create-medical-technology-company-4521935 http://www.medicaldevice-network.com/news/newssorin-cyberonics-create-medical-technology-company-4521935 Italian medical device firm Sorin Group and US-based Cyberonics have agreed to merge to create a new medical technology company with a combined equity value of $2.7bn. Fri, 27 Feb 2015 00:00:00 GMT Sunshine Heart gets FDA approval to conduct Counter HF study of C-Pulse system http://www.medicaldevice-network.com/news/newssunshine-heart-fda-hf-study-c-pulse-system-4520406 http://www.medicaldevice-network.com/news/newssunshine-heart-fda-hf-study-c-pulse-system-4520406 US-based medical device firm Sunshine Heart has received approval from US Food and Drug Administration (FDA) to carry out an interim analysis of Counter HF study of the C-Pulse Heart Assist System (C-Pulse system). Thu, 26 Feb 2015 00:00:00 GMT Agena introduces MassARRAY 24-Well System for genetic analysis http://www.medicaldevice-network.com/news/newsagena-massarray-24-well-system-genetic-analysis-4519812 http://www.medicaldevice-network.com/news/newsagena-massarray-24-well-system-genetic-analysis-4519812 US-based Agena Bioscience has extended its existing MassARRAY portfolio with the introduction of MassARRAY 24-Well System for mass spectrometry-based genetic analysis. Wed, 25 Feb 2015 00:00:00 GMT FDA grants 510(k) clearance for Bioness' StimRouter to treat chronic peripheral pain http://www.medicaldevice-network.com/news/newsbioness-stimrouter-chronic-peripheral-pain-4519854 http://www.medicaldevice-network.com/news/newsbioness-stimrouter-chronic-peripheral-pain-4519854 The US Food and Drug Administration (FDA) has granted 510(k) clearance for Bioness' StimRouter, an implantable neuromodulation device, designed to treat chronic, intractable pain of peripheral nerve origin. Wed, 25 Feb 2015 00:00:00 GMT Rhenus http://www.medicaldevice-network.com/contractors/distribution/rhenus-logistics/4077902265001.html http://www.medicaldevice-network.com/contractors/distribution/rhenus-logistics/4077902265001.html This video is about contract logistics by Rhenus. Tue, 24 Feb 2015 15:01:00 GMT NSF International to Attend the 54th Annual Meeting and ToxExpo http://www.medicaldevice-network.com/contractors/consultancy_services/nsf-health-science-consulting/pressnsf-international-54th-annual-meeting-toxexpo.html http://www.medicaldevice-network.com/contractors/consultancy_services/nsf-health-science-consulting/pressnsf-international-54th-annual-meeting-toxexpo.html NSF International will be attending the 54th Annual Meeting and ToxExpo from 22-26 March. Tue, 24 Feb 2015 10:14:00 GMT Optimizing Medical Device Product Development to Meet Regulatory Requirements and Avoid Costly Delays http://www.medicaldevice-network.com/downloads/whitepapers/consultancy_services/product-development-regulatory-requirements/ http://www.medicaldevice-network.com/downloads/whitepapers/consultancy_services/product-development-regulatory-requirements/ The business of medical device manufacturing got considerably more complicated in 2010 when the US Food and Drug Administration (FDA) began requiring manufacturers to conduct tests and provide more detailed information about extractables and leachabl… Tue, 24 Feb 2015 09:43:00 GMT Combination Products: A 40 Year Regulatory Evolution http://www.medicaldevice-network.com/downloads/whitepapers/consultancy_services/combination-products-regulatory-evolution/ http://www.medicaldevice-network.com/downloads/whitepapers/consultancy_services/combination-products-regulatory-evolution/ Technological advances in healthcare products and delivery of those products will continue to straddle traditional boundaries of regulatory authority between US Food and Drug Administration's (FDA) medical product centres. Tue, 24 Feb 2015 09:42:00 GMT Regulatory Overview of Proposed LDT Framework http://www.medicaldevice-network.com/downloads/whitepapers/consultancy_services/regulatory-overview-proposed-ldt-framework/ http://www.medicaldevice-network.com/downloads/whitepapers/consultancy_services/regulatory-overview-proposed-ldt-framework/ On 31 July, 2014, US Food and Drug Administration (FDA) notified the Senate Committee on Health, Education, Labour and Pensions and the House Committee on Energy and Commerce of the FDA's intent to issue two draft guidance documents on FDA's regulati… Tue, 24 Feb 2015 09:35:00 GMT Managing Cleanrooms and Sterile Medical Device Products: The Importance of Training in Maintaining High Standards http://www.medicaldevice-network.com/downloads/whitepapers/consultancy_services/managing-cleanrooms-sterile-medical-device-products/ http://www.medicaldevice-network.com/downloads/whitepapers/consultancy_services/managing-cleanrooms-sterile-medical-device-products/ Whether you are new to manufacturing sterile medical devices or a veteran of the industry, continuous education and training are essential. Tue, 24 Feb 2015 09:29:00 GMT US FTC fines marketers of two melanoma detection apps http://www.medicaldevice-network.com/news/newsus-ftc-fines-marketers-melanoma-detection-apps-4518884 http://www.medicaldevice-network.com/news/newsus-ftc-fines-marketers-melanoma-detection-apps-4518884 The US Federal Trade Commission (FTC) has fined marketers of two melanoma detection apps, MelApp and Mole Detective, over claims of insufficient scientific support. Tue, 24 Feb 2015 00:00:00 GMT FDA approves Medtronic’s VenaSeal closure system to treat varicose veins http://www.medicaldevice-network.com/news/newsfda-medtronic-venaseal-closure-system-varicose-veins-4517866 http://www.medicaldevice-network.com/news/newsfda-medtronic-venaseal-closure-system-varicose-veins-4517866 Medtronic has received approval from US Food and Drug Administration (FDA) for the VenaSeal closure system. Mon, 23 Feb 2015 00:00:00 GMT Helius Medical enrols first patients in multiple sclerosis feasibility trial of PoNS device http://www.medicaldevice-network.com/news/newshelius-medical-multiple-sclerosis-feasibility-trial-pons-device-4516770 http://www.medicaldevice-network.com/news/newshelius-medical-multiple-sclerosis-feasibility-trial-pons-device-4516770 US-based Helius Medical Technologies has enrolled the first three subjects in the Multiple Sclerosis (MS) feasibility trial of its Portable Neuromodulation Stimulator (PoNS) device at the Montreal Neurological Institute and Hospital, and Concordia Un… Fri, 20 Feb 2015 00:00:00 GMT FDA approves marketing of 23andMe's genetic carrier test for Bloom syndrome http://www.medicaldevice-network.com/news/newsfda-23andme-genetic-carrier-test-bloom-syndrome-4516915 http://www.medicaldevice-network.com/news/newsfda-23andme-genetic-carrier-test-bloom-syndrome-4516915 US Food and Drug Administration (FDA) has granted approval for marketing 23andMe's Bloom Syndrome carrier test, a direct-to-consumer (DTC) genetic test to determine whether a healthy person has a variant in a gene that could lead to their offspring i… Fri, 20 Feb 2015 00:00:00 GMT Multisorb to Showcase Liquid Medical Waste Solutions at AORN Surgical Conference and Expo http://www.medicaldevice-network.com/contractors/packaging/multisorbtechnologies/pressmultisorb-liquid-medical-waste-solutions-aorn.html http://www.medicaldevice-network.com/contractors/packaging/multisorbtechnologies/pressmultisorb-liquid-medical-waste-solutions-aorn.html Multisorb Technologies has announced it will exhibit its medical spill and liquid containment solutions at AORN Surgical Conference and Expo in Denver Colorado from March 8-10 2015. Thu, 19 Feb 2015 09:43:00 GMT Marathon and Medline partner to distribute ZiNGO handheld device http://www.medicaldevice-network.com/news/newsmarathon-medline-partner-zingo-handheld-device-4515840 http://www.medicaldevice-network.com/news/newsmarathon-medline-partner-zingo-handheld-device-4515840 Marathon Pharmaceuticals has partnered with Medline Industries to market and distribute ZiNGO (lidocaine hydrochloride monohydrate, 0.5mg) powder intradermal injection system, a needle-free, easy-to-use device. Thu, 19 Feb 2015 00:00:00 GMT FDA grants 510(k) clearance for Seegene's HSV molecular test http://www.medicaldevice-network.com/news/newsfda-510k-clearance-seegene-hsv-molecular-test-4514815 http://www.medicaldevice-network.com/news/newsfda-510k-clearance-seegene-hsv-molecular-test-4514815 The US Food and Drug Administration (FDA) has granted 510(k) market clearance for South Korean developer of multiplex PCR technologies, Seegene's TOCE-based herpes simplex virus (HSV) types 1 and 2 assay. Wed, 18 Feb 2015 00:00:00 GMT Mitsubishi develops new multi-function irradiation nozzle for cancer treatment http://www.medicaldevice-network.com/news/newsmitsubishi-multi-function-irradiation-nozzle-cancer-treatment-4514772 http://www.medicaldevice-network.com/news/newsmitsubishi-multi-function-irradiation-nozzle-cancer-treatment-4514772 Mitsubishi Electric has developed a new multi-function irradiation nozzle for proton-type particle therapy systems for cancer treatment. Wed, 18 Feb 2015 00:00:00 GMT FDA clears Medtronic's expanded indications of Vertex reconstruction system http://www.medicaldevice-network.com/news/newsmedtronic-expanded-indications-vertex-reconstruction-system-4513791 http://www.medicaldevice-network.com/news/newsmedtronic-expanded-indications-vertex-reconstruction-system-4513791 The US Food and Drug Administration (FDA) has granted clearance for Irish medical technology firm Medtronic's expanded indications of the Vertex Reconstruction System. Tue, 17 Feb 2015 00:00:00 GMT