Nasdaq Corporate Solutions and Computershare to Simplify Access to Beneficial Shareholder Data for Corporate Issuers in Australia and New Zealand
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Date24 Sep 2017
SYDNEY and MELBOURNE, Australia, Sept. 24, 2017 (GLOBE NEWSWIRE) — Nasdaq Corporate Solutions, a business of Nasdaq, Inc. (Nasdaq:NDAQ), and Computershare Investor Service Pty Ltd, a... Read More →
iLOOKABOUT Launches New Mobile Appraiser Product at IAAO Conference
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Date24 Sep 2017
TORONTO, Sept. 24, 2017 (GLOBE NEWSWIRE) — iLOOKABOUT Corp. (TSXV:ILA) (“iLOOKABOUT” or “the Company”) today announced that it has launched its newest product, the GeoViewport... Read More →
Aerojet Rocketdyne Supports ULA Launch of Classified Satellite for the U.S. Government
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Date24 Sep 2017
SACRAMENTO, Calif., Sept. 24, 2017 (GLOBE NEWSWIRE) — Aerojet Rocketdyne, Inc., a subsidiary of Aerojet Rocketdyne Holdings, Inc. (NYSE:AJRD), successfully supported the launch of a... Read More →
Novelion Therapeutics Observes Familial Hypercholesterolemia Awareness Day
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Date24 Sep 2017
VANCOUVER, British Columbia, and CAMBRIDGE, Mass., Sept. 24, 2017 (GLOBE NEWSWIRE) — Novelion Therapeutics Inc. (NASDAQ:NVLN), a biopharmaceutical company dedicated to developing new standards of... Read More →
Micromem: Provides Current Update
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Date23 Sep 2017
TORONTO and NEW YORK, Sept. 22, 2017 (GLOBE NEWSWIRE) — Micromem Technologies Inc. (CSE:MRM) (OTCQB:MMTIF) (“Micromem”) (“the Company”) and its wholly owned subsidiary Micromem Applied... Read More →
Abiomed recebe aprovação PMA da FDA para a bomba cardíaca Impella RP® para insuficiência cardíaca direita
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Date23 Sep 2017
DANVERS, Massachusetts, Sept. 22, 2017 (GLOBE NEWSWIRE) — A Abiomed, Inc. (NASDAQ:ABMD), provedora líder de tecnologias revolucionárias de suporte e recuperação cardíacos, anunciou hoje que... Read More →
Abiomed 的 Impella RP® 獲得美國食品藥物管理局 (FDA) 上市前核准 (PMA) 可用於治療右心衰竭
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Date23 Sep 2017
馬薩諸塞州丹佛斯市, Sept. 23, 2017 (GLOBE NEWSWIRE) — Abiomed, Inc.(NASDAQ:ABMD),一間領先的突破性心臟支援及功能恢復技術供應商,今日發佈消息稱,公司的 Impella RP® 心臟泵獲得美國食品藥物管理局 (FDA) 上市前核准 (PMA)。歷經五年的研究工作告一段落,此項批准緊隨先前於 2015 年 1 月所獲得的 FDA 人道主義器械豁免(Humanitarian Device Exemption,簡稱為 HDE)之後,將 Impella... Read More →
아비오메드의 우심부전용 Impella RP®, FDA로부터 시판 전 허가(PMA) 획득
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Date23 Sep 2017
미국 매사추세츠주 댄버스, Sept. 23, 2017 (GLOBE NEWSWIRE) — 혁신적인 심장 보조장치 기술을 개발하는 선도기업 아비오메드(Abiomed, Inc.)(NASDAQ:ABMD)는 미국 식품의약국(FDA)으로부터 Impella RP® 인공심장 펌프에 대한 시판... Read More →
Abiomed recibe la Aprobación PMA de la FDA para Impella RP® y el tratamiento de la Insuficiencia Cardíaca Derecha
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Date23 Sep 2017
DANVERS, Mass., Sept. 22, 2017 (GLOBE NEWSWIRE) — Abiomed, Inc. (NASDAQ:ABMD), un proveedor líder en asistencia cardíaca avanzada y en tecnología de rehabilitación, anunció hoy... Read More →
Abiomed获得FDA PMA批准其Impella RP®用于治疗右心衰竭
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Date23 Sep 2017
马萨诸塞州丹弗斯, Sept. 23, 2017 (GLOBE NEWSWIRE) — 突破性心脏支持和恢复技术的领先提供商Abiomed,Inc. (NASDAQ: ABMD) 今天宣布已收到美国食品和药物管理局(FDA)对于Impella RP®心脏泵的上市前批准(PMA)。五年的研究终于达到高峰。该项批准是之前于2015年1月收到的“FDA人道主义装置豁免原则(HDE)”的后续,并使Impella RP心脏泵加入到Abiomed的PMA批准设备的平台行列上。 该项批准,令Impella RP心脏泵成为经FDA批准的唯一经皮配置的临时心室支持装置,可安全有效地用于治疗右心衰竭,如以下所示: Impella RP系统可用于在左心室辅助装置植入、心肌梗死、心脏移植或心脏开腔手术后发展为急性右心衰竭或代偿失调的、身体表面积≥1.5 m2的患者中提供长达14天的临时右心室支持。 提交给FDA的、用于支持Impella RP心脏泵PMA的数据包括RECOVER RIGHT1 FDA批准的、前瞻性的、多中心的单臂研究。该研究在公司于2012年11月获得FDA研究设备豁免(IDE)批准后开始,并于2014年结束。自此,Abiomed完成了持续访问协议(CAP)以及前瞻性的、多中心的批准后研究(PAS)。这些数据是在“国际心脏和肺移植学会2017年度会议和科学会议”的全体会议上提出的2。Impella RP心脏泵由Medicare和其他主要付款方报销。Abiomed将完成由经Abiomed的机构审查委员会(IRB)批准、FDA审核的前瞻性cVAD注册系统中的60位连续患者参与的一项PMA批准后研究。 右心室功能不全(RVF)与较高的死亡率、更长的重症监护病房停留时间和潜在的末期器官功能障碍相关1。Impella RP心脏泵稳定患者的血液动力学、降减右心室负荷并允许原生心脏得到恢复。Impella... Read More →