Etiometry’s Platform for Clinical Decision Support Software Earns 6th FDA Clearance

临床决策支持软件的病因学平台获得第6次FDA许可

2020-12-03 01:31:28 BioSpace

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Newly cleared software updates based on feedback from platform’s clinician users BOSTON--(BUSINESS WIRE)-- Etiometry, the leader in clinical decision-support software for critical care, today announced it has received its 6th 510(k) clearance from the US Food and Drug Administration (FDA) adding several new features to the Etiometry Platform. Included are two significant enhancements to their previously cleared patient risk indices. These upgrades provide flexibility to adjust index thresholds to achieve individualized patient risk assessment based on patient condition and needs. They also provide further insight into the primary physiologic factors that are contributing to a patient’s risk index at a given time. Also included in this recent clearance is Etiometry’s Surveillance View, which provides remote unit-wide viewing of patients on a single display. “With the new flexibility to accommodate different patient conditions and the increased transparency of our indices, we have a steppingstone into new markets and effective drivers for further clinical utilization that broaden the benefits of the Etiometry Platform.” explained Etiometry’s Chief Technology Officer and Co-founder, Dimitar Baronov. Last year, Etiometry received FDA clearance for its second ground-breaking patient risk index - the Inadequate Ventilation of Carbon Dioxide (IVCO2) Index™; which joined the Inadequate Delivery of Oxygen (IDO2) Index™ in the company’s growing repertoire of model-based analytics for proactive patient assessment. The platform also includes T3 Data Aggregation & Visualization Software which enables clinicians to review comprehensive trended patient data including key vital sign parameters, lab results, and medical device inputs. About the Latest Etiometry Platform Enhancements Selectable Risk Index Thresholds – Clinicians can now select a patient-centered threshold for IDO2 and IVCO2 indices that allow for a more meaningful baseline of an individual patient’s complex condition which translates into more personalized, actionable data for the clinician. Measurement Contributions – This feature gives clinicians insights into what values from primary monitoring sources are contributing to elevated patient risk index scores by hovering over a trended risk index within the platform for a more transparent assessment. “This FDA clearance, spurred by clinician user feedback, illustrates how agile our team is in rapidly iterating software to provide even greater value to our users for faster, more contextual clinical decision support,” said Shane Cooke, Etiometry President and Chief Executive Officer. “These features enable expanded applications in wider patient populations, which is critical as we have entered new market segments such as the NICU and adult ICUs,” added Cooke. About Etiometry Etiometry Inc. is the leader in clinical decision-support software for the intensive care environment. Our technologies provide valuable clinical insight and analysis to support early recognition of subtle changes in patient condition to avoid complications and speed recovery. Etiometry is committed to improving patient outcomes, increasing clinical efficiency, and lowering costs of care through the more effective use of all available data. For more information, visit www.etiometry.com View source version on businesswire.com: https://www.businesswire.com/news/home/20201202005725/en/ Lauren Titus, Director of Marketing Etiometry ltitus@etiometry.com Source: Etiometry View this news release online at: http://www.businesswire.com/news/home/20201202005725/en
根据来自平台临床医生用户的反馈新清除的软件更新 波士顿--(商业热线)--重症监护临床决策支持软件的领导者Etiometry公司今天宣布,它已获得美国食品和药物管理局(FDA)的第6次510(k)许可,为Etiometry平台增加了几项新功能。包括两个重要的增强之前清除的病人风险指数。这些升级提供了调整指标阈值的灵活性,以实现基于患者病情和需求的个体化患者风险评估。他们还提供了对主要生理因素的进一步洞察,这些因素在给定的时间内对患者的风险指数有贡献。最近的清除还包括Etiometry的监视视图,它提供了在单个显示器上对患者进行远程单元范围的查看。 Etiometry首席技术官兼联合创始人Dimitar Baronov解释说:“随着适应不同患者情况的新灵活性和我们指数的透明度的提高,我们有了进入新市场的踏板和进一步临床应用的有效驱动因素,从而扩大了Etiometry平台的益处。” 去年,病因学获得FDA批准其第二个开创性的患者风险指数--二氧化碳通气不足(IVCO2)指数™;它加入了氧气供应不足(IDO2)指数™的行列,加入了公司不断增长的基于模型的分析,用于积极的患者评估。该平台还包括T3数据聚合和可视化软件,使临床医生能够审查全面的趋势患者数据,包括关键的生命体征参数,实验室结果和医疗设备输入。 关于病因学平台的最新增强功能 可选择的风险指数阈值--临床医生现在可以为IDO2和IVCO2指数选择一个以患者为中心的阈值,该阈值允许更有意义的单个患者复杂状况的基线,从而为临床医生转化为更个性化的,可操作的数据。 测量贡献--通过在平台内的趋势风险指数上悬停以进行更透明的评估,该功能使临床医生能够洞察来自主要监测源的哪些值有助于提高患者风险指数得分。 Etiometry公司总裁兼首席执行官Shane Cooke说:“由于临床医生用户的反馈意见,FDA的批准证明了我们的团队在快速迭代软件方面是多么敏捷,以便为我们的用户提供更快,更有背景的临床决策支持,从而提供更大的价值。Cooke补充说:“这些特性使我们能够在更广泛的患者群体中扩大应用,这对于我们进入新的市场细分领域如NICU和成人ICU是至关重要的。” 关于病因学 Etiometry公司是重症监护环境临床决策支持软件的领导者。我们的技术提供有价值的临床洞察和分析,支持早期识别患者病情的细微变化,以避免并发症和加速康复。病因学致力于通过更有效地利用所有可用数据来改善患者预后,提高临床效率,降低护理成本。 欲了解更多信息,请访问www.etiometry.com 在businesswire.com上查看源代码版本:https://www.businesswire.com/news/home/20201202005725/en/ Lauren Titus,市场总监 病因学 ltitus@etiometry.com 资料来源:《病因学》 在线查看此新闻稿: http://www.businesswire.com/news/home/20201202005725/en

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