upn-taipei news-medical-2011-4-16-15-STB MedTech Newsletter 創新醫療器材簡訊報導2011年4月刊

STB MedTech Newsletter 創新醫療器材簡訊報導2011年4月刊 STB公告 1. 2011年第一梯次STB計畫赴美人才招生已進入複選階段，初選結果請參閱STB計畫官網公告，複選面試後最終錄取名單預計將於4月底公布，屆時請留意STB網站公告。國際醫材新聞 杜克大學的研究人員以雷射技術開發的高解析度影像可協助醫師更好的診斷黑色素瘤 FUJIFILM Europe公司推出攜帶型X光數位影像系統FCR Go 2 GE Healthcare公司獲得FDA核准上市兩款磁振造影系統Optima MR360與Brivo MR355 Siemens公司公布最新開發的數位X光系統Multix Select DR Ventus Medical公司獲得歐盟核准上市其治療睡眠呼吸中止症的Provent®治療器材 Second Sight Medical公司的人工眼Argus II系統獲得歐洲核准上市 EndyMed Medical公司獲得FDA核准上市其創新技術的3DEEP分段式激光換膚儀器 Cardica公司獲得歐洲核准上市其Microcutter外科手術切割與縫合器材 低價的微型攝影機可能將微創手術用的內視鏡變為拋棄式 Volcano公司獲得日本核准上市其Eagle Eye®白金數位血管內超音波導管 西北大學的研究團隊開發一種可伸展的電子器材可將心臟燒灼手術用的感應器印刷於標準氣球擴張導管上 Hutchinson Technology公司獲得FDA核准上市其InSpectra StO2 Spot Check產品可協助於急救環境下快速評估組織灌流量與休克情形 CareFusion公司推出居家用的行動式呼吸器CareFusion LTV 1100 ventilator Intrapace公司開發的植入式胃調節器已在歐洲上市可作為胃繞道手術的替代療法刺激神經產生飽足感來治療肥胖 HealthOneMed公司創新的自動給藥器材能協助管理所有的居家用藥 PositiveID公司宣布完成iglucose可即時管理糖尿病的無線通訊系統的開發 南卡羅萊納醫科大學的研究人員開發新型的替代椎間盤內含活細胞的支架能提供更好的支撐與減少副作用 FDA以人道使用器材方式核准Elana公司的準分子雷射輔助非阻塞性吻合術ELANA手術套組上市 Microsoft公司開發一款搜尋工具可辨識醫學影像中的器官與其它構造 NASA使用HEALS光學技術開發的WARP 75器材可減輕癌症病患進行化療或放療的副作用 Sonitus Medical公司獲得歐洲核准上市其SoundBite骨導式助聽系統 Spaulding Clinical Research獲得FDA核准上市其手提式心電圖平台Spaulding IQ 牛津電磁聲波造影技術比傳統的超音波與MRI影像能提供更佳的診斷效能 荷蘭Skyline Diagnostics公司推出全球首件診斷用晶片結合DNA技術用於快速分類急性骨髓性白血病病患 Merit Medical Systems公司獲得FDA核准上市其ASAP血栓抽吸導管 亞利桑納州立大學與梅約醫學中心的工程師開發新式的血糖感測器可偵測分析淚液中的血糖值 加州大學柏克萊分校與都柏林城市大學的研究團隊開發新的微流體裝置可快速檢測全血樣本來診斷疾病 Cardiovascular Systems公司獲得FDA核准上市其Stealth 360°(TM) Orbital PAD System用於治療周邊動脈疾病 Philips公司推出專為男性面部構造設計的鼻枕式面罩GoLife for Men用於治療睡眠呼吸疾病 NeuroFocus公司發表全球首件無線全腦域腦波測量頭罩Mynd 萊斯大學的研究人員開發出一種如骨骼與肌肉般在經過重複給予壓力後會變更強硬扎實的奈米複合材料 BK Medical公司發表業界首個針對機器人手術用的ART超音波影像技術 日本關西大學的研究人員模擬蚊子的口器開發出較不痛的注射針頭 Medtronic公司獲得FDA核准上市其Consulta與Syncra心臟再同步治療的心律節律器系統 哈佛大學與麻省理工學院的研究人員開發一種奈米碳管的微流體器材可偵測血中的癌細胞或病毒 EnteroMedics公司獲得歐盟核准上市其第二代Maestro RC系統使用VBLOC迷走神經阻斷法治療肥胖症 CareFusion公司推出椎體成形術用的新型小尺寸氣囊提供治療脊椎骨折的新選擇 科學家開發出首個商品化的奈米發電器利用一種彈性晶片可將身體的動能轉為電力 Abbott公司獲得FDA核准上市其i-STAT 1無線定點照護檢測系統 Microline Surgical公司發表MiSeal熱接合系統使用專利熱壓焊接技術可於一次操作中縫合與切割軟組織 Medtronic公司獲得FDA核准上市其Interstim治療法使用薦骨神經電刺激用於控制排便失禁 GE Healthcare與AirStrip Technologies公司宣布其MUSE心臟病學資訊系統已能用於智慧型手機與平板電腦上讓醫師能即時查詢心電圖等資料 St. Jude Medical公司獲得FDA核准上市其兩款新型的雙向電燒導管 AngioDynamics公司推出新世代的DuraMax梯形吸管狀的長期透析用導管 Alphatec Spine公司獲得FDA核准上市其Solus前側腰椎椎體間融合系統 熱門醫材話題 許多體外診斷醫材公司正致力於開發可協助個人化醫療的先進產品以期降低成本 因應市場需求出現了將臨床技術應用於獸醫、身分辨識與鑑識以及食品安全等非臨床診斷測試用途上 郵票大小的微型泵浦已廣泛應用在重點照護檢驗與體外診斷器材上 新創公司在保護資產上該注意的事項 如何為你的醫療器材選擇對的作業系統 美國醫材公司在市場歷經困難之後仍持續創新活力 歐洲醫療技術產業協會Eucomed下設的中小企業專責小組力促歐盟改善醫療技術創新環境 MedTech技術與產業專欄 Technology Review's 50 Most Innovative Companies (TR50 2011) MIT科技評論評選出2011年全球最具創新力的50大企業 Technology Review《MIT科技評論》今年從全球的能源、交通、電腦與通訊、網絡與數位媒體、材料、生物醫學六大領域知名企業中，評選出「2011全球最具創新力的50大企業」，其中在生物醫學領域有6家上市公司與3家未上市的公司入榜，以下的公司連結中有該公司入選原因與創新技術簡介，有興趣的人可再自行參考：上市公司 Complete Genomics Geron Life Technologies Novartis Pacific Biosciences Roche 未上市公司 BIND Biosciences Cellular Dynamics International Claros Diagnostics Smartphone apps for clinical trials iPhone和其他智慧型手機平台上的醫療應用程式已有爆炸性的成長，使用者大多數是醫生和病患，但也有越來越多應用程式瞄準了藥物開發的客戶族群。這些應用程式能協助用戶尋找臨床試驗，並協助抓取與報告試驗的結果數據。另外醫療影像的應用程式也明顯有增加。下面是FierceBiotech IT網站上依幾個分類整理了一些智慧型手機和平板電腦的應用程式，期能幫助越來越多的行動派研發人員。 Subject Recruitment & Trial Finding TrialCentralNet, by TCN e-Systems CancerTrials App, by GlaxoSmithKline and Medtrust CT, by TrialX Clinical Trial 2.0, from Healogica Patient-reported Outcomes E-PRO, by Exco InTouch EXACT, by CRF Health E-trials eDiary 5.0 platform, by Merge Healthcare MedApps solution suite, via AT&T Subject Monitoring eMedonline telemonitoring dose management system Mobile cardiac telemetry diagnostic monitoring, by Arrhythmia Research Technology Mobile Clinical Results software, by PatientKeeper Malaria-tracking data transfer Electronic Data Capture & Clinical Trial Management Systems Prism 3.0, by Nextrials eClinical software suite, by DATATRAK Timaeus Hotspot, by Cmed Technology Project tracking app, by Calvert Labs Imaging EFilm Mobile, by Merge Healthcare eUnity, by Client Outlook Reference Mobile Journal Watch, by Skyscape and the Massachusetts Medical Society Product information request function, by Pfizer and Epocrates 2011 Medical Design Excellence Awards Winners 2011年醫療產品優秀設計獎得主 MDEA賽事是由Medical Device & Diagnostic Industry (MD&DI)雜誌主辦，它是醫療產品技術界爭相競爭的崇高榮譽，今年共有37項產品入選，依照產品類別介紹於下，有興趣的人可自行連結參考： Critical-Care and Emergency Medicine Products 急重症護理與急救醫療產品類 EV1000 clinical patient monitoring platform, manufactured and submitted by Edwards Lifesciences LLC (Irvine, CA). Lifeline View automated external defibrillator, manufactured and submitted by Defibtech LLC (Guilford, CT). Mindray V Series Patient Monitoring System, manufactured by Mindray (Mahwah, NJ). Entry submitted by Continuum (West Newton, MA). Dental Instruments, Equipment, and Supplies 牙科器械、設備與耗材類 AcceleDent Orthodontic System, manufactured by OrthoAccel (Houston, TX). Entry submitted by Devicix LLC (Eden Prairie, MN). Orascoptic Freedom cordless LED headlamp for dentists and hygienists, manufactured and submitted by Sybron Middleton (Middleton, WI). Propoint obturation point for use in root canal therapy, manufactured and submitted by DRFP Ltd. (Sheffield, South Yorkshire, United Kingdom). General Hospital Devices and Therapeutic Products 一般醫院器材與治療產品類 Compass interchangeable modular system, manufactured and submitted by Herman Miller Healthcare (Zeeland, MI). Conveen Active urine collecting bag, manufactured and submitted by Coloplast A/S (Humlebaek, Denmark). Encircle Compression Therapy device, manufactured by The Merino Co. (TMC Apparel) (Christchurch, New Zealand). Entry submitted by Locus Research Ltd. (Mt. Maunganui, Tauranga, New Zealand). Pegasus Safety Closed IV Catheter System, manufactured by Becton, Dickinson and Co. (Sandy, UT). Entry submitted by Becton Dickinson Medical Products Pte. Ltd. (Singapore). Pronto-7 handheld noninvasive hemoglobin spot-check testing device, manufactured and submitted by Masimo (Irvine, CA). Radiant Heat Warmer (RHW) 3000 series, manufactured by Zeal Medical Pvt. Ltd. (Mumbai, Maharashtra, India). Entry submitted by NEODES (PUNE, India). VeinViewer Vision vascular imaging device, manufactured and submitted by Christie Medical Holdings (Memphis, TN). Implant and Tissue-Replacement Products 植入與組織置換產品類 Cranial Loop nonmetallic, cranial fixation device for postcraniotomy bone flap fixation, manufactured and submitted by Neos Surgery S.L. (Barcelona-San Sebastián, Spain). JuggerKnot Soft Suture Anchor, manufactured and submitted by Biomet Sports Medicine (Warsaw, IN). MitraClip catheter-based mitral valve repair system, manufactured by Abbott Vascular (Menlo Park, CA). Entry submitted by Nicole Osmer Healthcare Communications (Menlo Park, CA). Triangular Prostatic Stent (TPS), manufactured and submitted by Allium Medical Solutions Ltd. (Caesarea Industrial Park, Israel). In Vitro Diagnostics 體外診斷產品類 cobas b 123 point-of-care blood gas analyzer system, manufactured and submitted by Roche Diagnostics Corp. (Indianapolis, IN). Integrated Cycler real-time polymerase chain reaction (PCR) thermocycler, manufactured and submitted by 3M (St. Paul, MN) and Focus Diagnostics Inc. (Cypress, CA). Leica BOND-III immunohistochemistry (IHC) and in-situ hybridization (ISH) staining system, manufactured by Leica Biosystems Melbourne Pty. Ltd. (Melbourne, Victoria, Australia). Entry submitted by Invetech (Melbourne, Victoria, Australia). MAGPIX versatile multiplexing bioassay platform, manufactured and submitted by Luminex Corp. (Austin, TX). Over-the-Counter and Self-Care Products 藥妝店銷售與自我護理產品類 Buzzy and Bee-Stractors needle pain relief system, manufactured and submitted by MMJ Labs LLC (Atlanta, GA). MalleoLoc ankle orthosis, manufactured by Bauerfeind AG (Zeulenroda-Triebes, Germany). Entry submitted by Bauerfeind USA Inc. (Marietta, GA). SpeediCath Compact Male intermittent catheter, manufactured and submitted by Coloplast A/S (Humlebaek, Denmark). Radiological and Electromechanical Devices 放射與機電器材產品類 Avedro Vedera KXS Vision Correction Device, manufactured by Avedro (Waltham, MA). Entry submitted by Continuum (West Newton, MA). LipiView Ocular Surface Interferometer, manufactured by TearScience (Morrisville, NC). Entry submitted by PR Strategies (Raleigh, NC). Selenia Dimensions tomosynthesis (3D) system, manufactured by Hologic Inc. (Bedford, MA). Entry submitted by Farm Design Inc. (Hollis, NH). Rehabilitation and Assistive-Technology Products 復健與輔具產品類 625 Barrier-Free Examination table, manufactured by Midmark Corp. (Versailles, OH). Entry submitted by Design Central Inc. (Columbus, OH). Inogen One G2 portable oxygen concentrator, manufactured and submitted by Inogen Inc. (Goleta, CA). Philips Lifeline Medical Alert Service with AutoAlert Option medical monitoring system, manufactured by Philips Design (Andover, MA). Entry submitted by Radius Product Development (Clinton, MA). Surgical Equipment, Instruments, and Supplies 手術設備、儀器與耗材產品類 DISTALOCK Intramedullary (IM) Nail and Drill System, manufactured by DGIMED Ortho Inc. (Minnetonka, MN). Entry submitted by Devicix LLC (Eden Prairie, MN). iO-Flex surgical system, manufactured and submitted by Baxano Inc. (San Jose, CA). PleuraFlow active tube clearance system, manufactured and submitted by Xeridiem Medical Devices (formerly MRI Medical) (Tucson, AZ). Talon grasping device, manufactured and submitted by US Endoscopy (Mentor, OH). The Mill powered surgical tool to aid in the preparation of bone graft, manufactured by Stryker Instruments (Kalamazoo, MI). Entry submitted by M3 Design Inc. (Round Rock, TX). UroLift System minimally invasive device, manufactured and submitted by Neotract (Pleasanton, CA). Venner A.P. Advance Video Laryngoscope, manufactured by Venner Medical Singapore Pte. Ltd. (Singapore). Entry submitted by Industrial Design Consultancy Ltd. (Datchet, Berkshire, United Kingdom). 醫療器材相關國際研討會 2011/04/16-19 2011/04/20-21 2011/04/26-27 2011/04/27-28 2011/05/2-5 2011/05/3-6 China International Medical Equipment Fair 2011 - 65th CMEF Spring 2011 BayBio2011 Annual Conference Medical Policy and Molecular Diagnostics/Genetic Testing Forum Reducing Legal Risks in the Sales and Marketing of Medical Devices International Symposium on Olfaction and Electronic Nose MEDCon - Medical Device Conference 2011 取消訂閱STB MedTech Newsletter 財團法人國家實驗研究院 科技政策研究與資訊中心 STB計畫辦公室地址：(10636)台北市和平東路二段106號16樓 EMAIL：stb@stpi.narl.org.tw　TEL：(02) 2737-7693　FAX：(02) 2737-7730 版權所有© 2011 STB Program, STPI