【HIMSS15看点速递（八）】Ambient Clinical Analytics临床决策支持工具AWARE获FDA许可，将在HIMSS15正式发布

来源：HIT专家网     沈建苗译

 编者按：作为全球医疗信息技术领域的年度盛典，HIMSS15全球年会将于2015年4月12日至16日在美国芝加哥隆重召开。本次大会共设立1200个展位。HIT专家网特设立HIMSS15专题播报栏目，将就一些参展企业及其将展出的产品方案亮点，做一些简要汇编，帮助国内同行快速领略HIT国际创新潮流。本期介绍的是Ambient Clinical Analytics公司。

Ambient Clinical Analytics公司近日宣布，其AWARE已获得了美国食品和药物管理局（FDA）的许可。AWARE是一种临床决策支持工具，同时结合了有科学依据的电子病历（EMR）查看工具。该产品运用数据分析技术，过滤相关的病人数据，并提供及时、实用的信息，从而为医生减少了信息过载。该产品的目的是，向医护团队的所有成员提供明确而简洁的实用信息，改善病人治疗效果，降低医护成本，并支持重症监护室（ICU）及其他危急科室的最佳护理实践。

FDA 510（k）许可面向2类医疗器材，这类器材提供了基于分析工具的临床决策支持，而1类查看工具和仪表板提供不了这样的临床决策支持。

首席执行官阿尔•伯宁（Al Berning）说：“获得FDA许可是Ambient Clinical Analytics提供的可以安装的综合临床决策系统方面的一个重要步骤。我们为在HIMSS15年会上发布AWARE而兴奋。”

AWARE是Ambient拥有的所有技术中的一项关键技术，并从梅奥诊所获得了使用许可，Ambient的技术正在改变重症监护医疗服务机构的运作方式。

Ambient Clinical Analytics为重症监护室、急诊科及在病人床边的其他重症监护区提供临床决策支持工具。除了AWARE外，Ambient Clinical Analytics的技术还包括：

• 梅奥诊所YES Board，这款多病人管理工具可以为急诊科及医疗儿科提供实时态势感知。

• Syndromic Surveillance，它提供了智能警报或“嗅探器”，可以处理败血症等重要的临床问题。

• Synthesis，同时面向YES Board和AWARE的这个组件，可以用移动设备将病人数据联系起来。

Ambient Clinical Analytics将在4月12日至15日于芝加哥召开的医疗IT年度盛会HIMSS15上正式发布AWARE。

作为该年会的尖端医疗IT产品之一，AWARE将与梅奥诊所YES Board和Syndromic Surveillance在# 5443展位上一同展示。

Ambient Clinical Analytics于去年在HIMSS年会上成立并首次参展，由来自梅奥诊所的世界一流的临床治疗团队创立，成员包括来自多个专科领域的医生，担任首席执行官的是阿尔•贝宁是有着20年从业经验的资深人士。

【Ambient Clinical Analytics简介】

Ambient Clinical Analytics销售功能强大的床边实时医疗数据同化、通讯和基于数据分析的临床决策工具，这些工具支持重症监护室、急诊科及其他重症监护区。软件许可费、软件即服务（SaaS）、云计算和系统集成等方面的收入共同支持其商业模式。Ambient Clinical Analytics拥有医生博士和公司高管组成的团队，他们在医学、临床研究和信息学、医疗产品及IT领域取得了不俗的成绩。欲了解更多内容，请访问公司网站：http://www.ambientclinicalanalytics.com

【参考原文】

Ambient Clinical Analytics Receives FDA 510(k) Clearance for Clinical Decision Support Tool AWARE; Commercial Availability to be Launched at HIMSS15

Rochester, MN (April 7, 2015) Ambient Clinical Analytics announced today it received 510(k) U.S. Food and Drug Administration (FDA) clearance for AWARE.  AWARE is a clinical decision support tool, combined with a scientifically supported EMR viewer.  The product reduces clinician information overload by using analytics to filter relevant patient data and provide timely, actionable information.  The goal of the product is to clearly and concisely present actionable information to all care team members to improve patient outcomes, reduce the cost of care, and support best-care practices for ICUs and other critical care areas.

The FDA 510(k) clearance is for Class 2 medical devices that provide analytics-based clinical decision support beyond that provided by Class 1 viewers and dashboards.

“FDA clearance is an important step for Ambient Clinical Analytics in providing a comprehensive clinical decision support system that is available for installation today. We are excited to be launching AWARE at HIMSS15”, said Al Berning, CEO.

AWARE is a pivotal technology in Ambient’s portfolio of technologies, licensed from Mayo Clinic, that are changing the way critical care providers operate.

Ambient Clinical Analytics provides clinical decision support tools for the ICU, Emergency Departments and other critical care areas right at the patient’s bedside. In addition to AWARE, Ambient Clinical Analytics’ technologies include:

Mayo Clinic YES Board , a multi-patient management tool that provides real-time situational awareness for Emergency Departments and hospital Pediatric departments;

Syndromic Surveillance, which delivers Smart alerts or “sniffers” that address important clinical problems such as sepsis;

Synthesis, a component for both the YES Board and AWARE, which connects patients’ data with mobile devices.

Ambient Clinical Analytics is announcing the commercial availability of AWARE at HIMSS15, the healthcare IT event of the year being held April 12 – 15 in Chicago.

One of the event’s cutting-edge health IT products, AWARE will be on display with Mayo Clinic YES Board , and Syndromic Surveillance in Booth # 5443.

Ambient Clinical Analytics was launched last year at HIMSS by a world-class founding clinical team from Mayo Clinic, including physicians from multiple specialties, who joined CEO Al Berning, a technology veteran of 20 years.

About Ambient Clinical Analytics

Ambient Clinical Analytics sells powerful bedside real-time healthcare data assimilation, communication, and analytics based clinical decision support tools that support the ICU, Emergency Department and other critical care areas. Our business model is supported by software license fees, SaaS, Cloud and system integration revenue.  Ambient Clinical Analytics have an MD and executive team with strong track records in medicine, clinical research and informatics, medical products and IT.