Health and Medical Devices News
ファーマネットがメディデータのCROパートナープログラムに参加
ニューヨーク--(BUSINESS WIRE)--（ビジネスワイヤ） -- SaaS型臨床開発ソリューションのリーディング・グローバル・プロバイダであるメディデータ・ソリューションズ（NASDAQ:MDSO）は本日、ファーマネット・デベロップメント・グループがメディデータのASPire to Win®チャンネル・パートナー・プログラムに参加したと発表しました。グローバルな医薬品開発サービス企業であるファーマネットは、国際共同治験の実施における効果的なツールとして、電子データ収集（EDC）および臨床データ管理（CDM）のリーディングソリューションMedidata Rave®を採用します。 ニュージャージーを拠点として世界に38ヶ所の施設を保有するファーマネットは、コンサルティング、第1相試験、生物学的同等性試験および薬力学試験、生物分析、第2～4相臨床開発プログラムを製薬、バイオテクノロジー、ジェネリック医薬品、医療機器企業に提供しています。ファーマネットは10年以上にわたって、商業的に利用可能なEDCシステム、ファーマネット独自のEDCシステムの双方を利用しながらEDC試験を実施し、経
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Lifeline Biotechnologies Continues FDA Filing Preparation Process for the First Warning System™
RENO, Nev.--(BUSINESS WIRE)--Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO) announced today that it has retained a new FDA consulting company to assist in the preparation and filing of its First Warning System™ 510(k) application. Jim Holmes, Lifeline’s CEO, said, “The work by the prior FDA consulting firm was partially but not fully completed. The process has caused delays and we have engaged a new firm to assist in the review of our data. There will be a determination as to the adequacy an
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New 2010 ESC Guidelines for Percutaneous Coronary Interventions Reinforce Importance of FFR in Treatment of Coronary Artery Disease
ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ) applauds the updated class and level of evidence for Fractional Flow Reserve (FFR)-guided treatment in the Guidelines on Percutaneous Coronary Intervention (PCI) announced Monday at the European Society of Cardiology (ESC) congress in Stockholm. Supporting this change are the very strong one and two year data from the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) trial, which demonstrate
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Teleflex to Present at the Stifel Nicolaus 2010 Healthcare Conference
LIMERICK, Pa.--(BUSINESS WIRE)--Jeffrey P. Black, Chairman and Chief Executive Officer, Teleflex Incorporated (NYSE: TFX), is scheduled to speak at the Stifel Nicolaus 2010 Healthcare Conference at the Four Seasons in Boston, Massachusetts, on Wednesday, September 15, 2010 at 9:10a.m. (ET). An audio webcast including the slide presentation will be available on the investor portion of the Teleflex website at www.teleflex.com. About Teleflex Incorporated Teleflex is a global provider of medical te
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Quidel Announces FDA Clearance of Its RapidVue® hCG Pregnancy Lateral Flow Diagnostic Test
SAN DIEGO--(BUSINESS WIRE)--Quidel Corporation (NASDAQ: QDEL), a leading provider of rapid diagnostic testing solutions, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of Quidel’s RapidVue® hCG test, a lateral flow pregnancy immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG). “Our customers have expressed a preference for testing flexibility and our new RapidVue hCG product provides healthc
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Samenvatting: PharmaNet wordt lid van CRO-partnerprogramma van Medidata Solutions
NEW YORK--(BUSINESS WIRE)--Medidata Solutions (NASDAQ: MDSO) maakt vandaag bekend dat PharmaNet Development Group lid is geworden van het partnerprogramma van Medidata, ASPire to Win. PharmaNet is een internationale dienstverlener binnen de ontwikkeling van geneesmiddelen. Het bedrijf gaat Medidata Rave gebruiken als effectief instrument bij de uitvoering van internationale klinische proeven. Medidata Rave is een vooraanstaande toepassing voor electronic data capture (EDC) en clinical data manag
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Resumen: PharmaNet se une al programa de socios CRO de Medidata Solutions
NUEVA YORK--(BUSINESS WIRE)--Medidata Solutions (NASDAQ: MDSO), proveedor líder mundial de soluciones de desarrollo clínico basado en SaaS, ha anunciado que PharmaNet Development Group se ha incorporado al programa de socios de canal ASPire to Win® de Medidata. Una empresa mundial de servicios de desarrollo de fármacos, PharmaNet añadirá Medidata Rave®, una solución líder de captura de datos electrónicos (EDC) y gestión de datos clínicos (CDM), como una herramienta efectiva en su realización de
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Vetter Opens New Sales Office at Illinois Science + Technology Park in Suburban Chicago
RAVENSBURG, Germany--(BUSINESS WIRE)--In keeping with its strategy of U.S. growth and expansion, Vetter, a specialist in aseptically prefilled drug-delivery systems, today announced that it has opened a new sales office at the Illinois Science + Technology Park in Skokie. The office will be managed by Mr. Troy Carpenter, who was appointed as President of Vetter Pharma International USA Inc. The new office replaces its Yardley, Pennsylvania sales office, founded in 1983 as Vetter Pharma-Turm Inc.
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Ovatech™ reports successful completion of Phase 2 clinical trial of Ovaprene™ non-hormonal intravaginal contraceptive ring
AUBURNDALE, Mass.--(BUSINESS WIRE)--Ovatech, an emerging women’s health-focused company, announced today that the Company’s Phase 2 clinical study of its non-hormonal, intravaginal contraceptive ring, Ovaprene, has been successfully completed. Ovaprene is a ‘one-size-fits-all’ patented, female-controlled, intravaginal organic silicone ring barrier-contraceptive that is designed to continuously release spermiostatic and spermicidal non-drug agents over a four-week period. In the Phase 2 study, ei
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ACR Image Metrix Expands Global Capabilities
PHILADELPHIA--(BUSINESS WIRE)--ACR Image Metrix™, an imaging contract research organization (CRO) with expertise in imaging trial design, techniques and data extraction, has expanded its global capabilities across all continents.
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Golden Helix Partners with CloudScientific to Provide Genetic Analysis Software in China
BOZEMAN, Mont.--(BUSINESS WIRE)--Golden Helix, Inc. today announced that it has entered into an agreement with CloudScientific, a Chinese life sciences software company, to act as a distributor of the company’s software and services.
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PharmaNet schließt sich dem CRO-Partnerprogramm von Medidata Solutions an
NEW YORK--(BUSINESS WIRE)--Medidata Solutions (NASDAQ: MDSO), ein führender globaler Anbieter von SaaS-Lösungen (Software-as-a-Service) für die klinische Entwicklung, gab heute bekannt, dass die PharmaNet Development Group seinem ASPire to Win®-Vertriebspartnerprogramm beigetreten ist. PharmaNet ist ein weltweit tätiger Anbieter von Diensten für die Arzneimittelentwicklung und wird Medidata Rave®, eine führende Lösung für die elektronische Datenerfassung (Electronic Data Capture, EDC) und die Ve
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PharmaNet intègre le programme de partenariat des CRO de Medidata Solutions
NEW YORK--(BUSINESS WIRE)--Medidata Solutions (NASDAQ: MDSO), un leader mondial en solutions hébergées de développement clinique, a annoncé aujourd’hui l’inscription de PharmaNet Development Group à son programme de partenariat ASPire to Win®. PharmaNet, une entreprise internationale de services de développement biologique, va intégrer Medidata Rave®, une solution de pointe de capture et de gestion de données informatisées (EDC & CDM), dans sa gamme d’outils performants d’essais cliniques. F
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Riassunto: PharmaNet si unisce al partner program CRO di Medidata Solutions
NEW YORK--(BUSINESS WIRE)--Medidata Solutions (NASDAQ: MDSO), ), fornitore leader a livello mondiale di soluzioni per lo sviluppo clinico basate su SaaS, ha annunciato oggi che PharmaNet Development Group si è unito al programma partner ASPire to Win®di Medidata. Una società globale incentrata sui servizi per lo sviluppo di farmaci, PharmaNet incorporerà Medidata Rave®, una soluzione all’avanguardia per la raccolta elettronica dei dati (EDC) e la gestione di dati clinici (CDM), come strumento ef
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ClearCount Medical Solutions Closes $5M Series B Financing Round
PITTSBURGH--(BUSINESS WIRE)--Medical Device company that prevents retained surgical sponges lands $5M in Series B financing.
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PharmaNet Joins Medidata Solutions’ CRO Partner Program
NEW YORK--(BUSINESS WIRE)--PharmaNet joins Medidata Solutions' CRO partner program Aspire to Win. The global CRO will offer the full portfolio of Medidata Rave services to support customers’ clinical programs.
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Aethon Names Kevin Newton Vice President of Operations and Quality Assurance
PITTSBURGH--(BUSINESS WIRE)--Aethon Names Kevin Newton Vice President of Operations and Quality Assurance
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Gary O'Hara Named Chief Technology Officer at Sanomedics
MIAMI--(BUSINESS WIRE)--Gary O'Hara has been named Chief Technology Officer for Sanomedics International Holdings. Mr. O'Hara brings over 25 years of leading medical and technological product innovation.
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Article Stresses Value of Safe Design for IV Connectors
FRANKLIN, Tenn.--(BUSINESS WIRE)--A new article about IV catheter care warns that several IV needleless connector designs are prone to repeated blood reflux that can cause the build-up of fibrin, which is a precursor to bacterial colonization and catheter-related bloodstream infections (CR-BSI). Only one design – a “zero fluid displacement connector” -- does not cause blood reflux, the authors say. The article, titled “Improving IV Catheter Care to Safeguard against Deadly Infections,” is the co
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Orthofix International Establishes New $300 Million Credit Facility
BOSTON--(BUSINESS WIRE)--Orthofix International N.V. (NASDAQ: OFIX) (the Company) announced today that it has established a new $300 million five-year credit facility, including a $200 million senior secured revolving line of credit and a $100 million senior secured term loan. JP Morgan Chase Bank, N.A. acted as Sole Bookrunner and Joint Lead Arranger along with RBS Citizens. JP Morgan Chase Bank, N.A. is acting as Administrative Agent and RBS Citizens, N.A. acted as Syndication Agent for the ba
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