This trial tests how well personalized ultra fractionated stereotactic adaptive radiotherapy (PULSAR) works together with HyperArc© radiation treatment planning technology for palliative (holistic pain and symptom control) tumor control in patients with primary or recurrent, localized or metastatic head and neck cancer (HNC) who are ineligible for or decline standard of care treatment. Researchers want to evaluate if using HyperArc and PULSAR together will deliver higher, possibly more effective doses, resulting in better tumor control with the same or fewer side effects than smaller routine doses. PULSAR is a radiation therapy regimen that uses a limited number of fairly large dose pulses while adjusting to specific anatomic and/or biological changes which may occur during the course of the treatment. HyperArc radiation treatment planning technology is a tool that allows for target dose escalation to tumor tissue while maintaining minimal head and neck organs-at-risk doses compared to other radiation treatment planning software. Undergoing PULSAR and HyperArc technology together may be a safe and effective palliative treatment option for patients with HNC.

开始日期2024-12-14

申办/合作机构

Jonsson Comprehensive Cancer Center

[+1]

NCT06111313 / Recruiting临床2期IIT

A Phase 2 Risk Adapted Parallel Randomized Trial of MRI-Guided Lattice Stereotactic Focal Radiotherapy of the Prostate With or Without Ultra-Short Term Androgen Deprivation Therapy-The Miami UAdapt Trial

The Miami UAdapt Trial is a non-comparative, risk adapted, parallel, randomized, phase 2 study for patients with favorable-intermediate to very high risk non-metastatic prostate cancer with the primary objective of assessing the efficacy and modulation of response of Lattice Extreme Ablative Dose (LEAD) RT with and without androgen deprivation therapy (ADT) at a multidimensional level.

开始日期2024-12-01

申办/合作机构

University of Miami

[+1]

100 项与 Siemens Healthineers AG 相关的临床结果

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0 项与 Siemens Healthineers AG 相关的专利（医药）

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2,294

项与 Siemens Healthineers AG 相关的文献（医药）

2025-01-01·CLINICA CHIMICA ACTA

Emergency department clinical performance of ADVIA Centaur n-terminal prohormone of B-type natriuretic peptide assay

作者: Januzzi, James L. ; Brown, Chadwick ; Frank Peacock, W. ; Januzzi, James L ; Cooper, Charles K ; Liu Liu, Yan ; Snyder, Jennifer ; Frank Peacock, W

BACKGROUND:

Natriuretic peptide testing is guideline recommended as an aid to the diagnosis of heart failure (HF). We sought to evaluate the performance of the ADVIA Centaur (Siemens Healthcare Diagnostics, Tarrytown, NY) NT-proBNPII assay (PBNPII) in emergency department (ED) dyspneic patients.

METHODS:

Eligible patients presented to the ED with dyspnea, with their gold standard diagnosis determined by up to 3 cardiologists blinded to the PBNPII results. Patients were stratified into 3 groups based on PBNPII resultsa rule out group of NT-proBNP<300 pg/mL, an age-specific rule in group using cutoffs of 450, 900, and 1800 pg/mL, for <50, 50-75, and > 75 years respectively, and an intermediate cohort for results between the rule out and rule in groups.

RESULTS:

Of 3128 eligible patients, 1148 (36.7 %) were adjudicated as acute heart failure (AHF). The gold standard AHF diagnosis rate was 3.7, 24.3, and 67.2 % for patients with NTproBNPII in the negative, indeterminate, and positive groups, respectively. Overall likelihood ratios (LR) were 0.07 (95 % CI: 0.05,0.09), 0.55 (0.45,0.67), and 3.53 (3.26,3.83) for the same groups, respectively. Individual LR+for age dependent cutoffs were 5.01 (4.25,5.91), 3.71 (3.25,4.24), and 2.38 (2.10,2.69), respectively. NTproBNPII increased with increasing severity of HF when stratified by NYHA classification.

CONCLUSIONS:

The ADVIA Centaur PBNPII assay demonstrates acceptable clinical performance using the recommended single rule out and age dependent rule in cutoffs for an AHF diagnosis in dyspneic ED patients.

2024-12-01·MODERN PATHOLOGY

Regulatory Aspects of Artificial Intelligence and Machine Learning

Review

作者: Henricks, Walter H ; Rashidi, Hooman H ; Lennerz, Joe ; Quinn, Bruce ; Bennet, Shannon ; Hanna, Matthew ; Pantanowitz, Joshua ; Shen, Peter ; Pantanowitz, Liron

In the realm of healthcare, numerous generative and non-generative artificial intelligence and machine learning (AI-ML) tools have been developed and deployed. Simultaneously, manufacturers of medical devices are leveraging AI-ML. However, the adoption of AI in healthcare raises several concerns, including safety, security, ethical biases, accountability, trust, economic impact, and environmental effects. Effective regulation can mitigate some of these risks, promote fairness, establish standards, and advocate for more sustainable AI practices. Regulating AI tools not only ensures their safe and effective adoption but also fosters public trust. It is important that regulations remain flexible to accommodate rapid advances in this field to support innovation and also not to add additional burden to some of our preexisting and well-established frameworks. This article covers regional and global regulatory aspects of AI-ML including data privacy, Software as a Medical device (SaMD), agency approval and clearance pathways, reimbursement, and laboratory developed tests (LDTs).

2024-12-01·INVESTIGATIVE RADIOLOGY

Deep Learning Reconstructed New-Generation 0.55 T MRI of the Knee—A Prospective Comparison With Conventional 3 T MRI

Article

作者: Obmann, Markus M ; Harder, Dorothee ; Seng, Magdalena ; Bach, Michael ; Breit, Hanns-Christian ; Vosshenrich, Jan ; Schmaranzer, Florian ; Nickel, Marcel Dominik ; Segeroth, Martin ; Donners, Ricardo ; Todorski, Inga ; Fenchel, Matthias

Objectives:

The aim of this study was to compare deep learning reconstructed (DLR) 0.55 T magnetic resonance imaging (MRI) quality, identification, and grading of structural anomalies and reader confidence levels with conventional 3 T knee MRI in patients with knee pain following trauma.

Materials and Methods:

This prospective study of 26 symptomatic patients (5 women) includes 52 paired DLR 0.55 T and conventional 3 T MRI examinations obtained in 1 setting. A novel, commercially available DLR algorithm was employed for 0.55 T image reconstruction. Four board-certified radiologists reviewed all images independently and graded image quality, noted structural anomalies and their respective reporting confidence levels for the presence or absence, as well as grading of bone, cartilage, meniscus, ligament, and tendon lesions. Image quality and reader confidence levels were compared (P < 0.05, significant), and MRI findings were correlated between 0.55 T and 3 T MRI using Cohen kappa (κ).

Results:

In reader's consensus, good image quality was found for DLR 0.55 T MRI and 3 T MRI (3.8 vs 4.1/5 points, P = 0.06). There was near-perfect agreement between 0.55 T DLR and 3 T MRI regarding the identification of structural anomalies for all readers (each κ ≥ 0.80). Substantial to near-perfection agreement between 0.55 T and 3 T MRI was reported for grading of cartilage (κ = 0.65–0.86) and meniscus lesions (κ = 0.71–1.0). High confidence levels were found for all readers for DLR 0.55 T and 3 T MRI, with 3 readers showing higher confidence levels for reporting cartilage lesions on 3 T MRI.

Conclusions:

In conclusion, new-generation 0.55 T DLR MRI provides good image quality, comparable to conventional 3 T MRI, and allows for reliable identification of internal derangement of the knee with high reader confidence.

803

项与 Siemens Healthineers AG 相关的新闻（医药）

2024-11-18

·PRNewswire

ECHOLIGHT ANNOUNCES MULTI-YEAR AGREEMENT WITH SIEMENS HEALTHINEERS

HOUSTON, Nov. 18, 2024 /PRNewswire/ -- Echolight, a global innovator in bone densitometry, announced that it has signed an agreement enabling Siemens Healthineers to be a reseller of Echolight bone densitometers in support of their Women's Health solutions. Continue Reading EchoStation from Echolight Medical Echolight's REMS (Radiofrequency Echographic Multi Spectometry) innovative technology measures bone density and microarchitecture without using the radiation of traditional x-ray scans but instead through a simple ultrasound scan of axial anatomical sites such as the spine and femur. This radiation-free technology allows physicians to perform repeated scans for monitoring bone health over time. In addition, the ability to automatically exclude artifacts commonly present with other densitometry procedures yields a highly reliable diagnostic assessment. "Bone health is a serious problem here in the US. This agreement provides expanded provider and patient access to REMS technology in the US through ultrasound-based bone density scanning as another option in the effort to diagnose and monitor bone health. Echolight is pleased to support Siemens Healthineers in their focus on women's health and bone disease," explained Thomas J. McLaughlin, Executive Commercial Director, Echolight USA. Echolight's portable solution measures bone quantity and quality simultaneously, through evaluation of bone mineral density at the lumbar vertebrae (L1-L4) and the femoral neck providing all common parameters of the diagnosis of osteoporosis BMD (g/cm2), T-scores, and Z-score. It also measures fragility score through an independent assessment of internal bone structure to evaluate the risk of fracture in 5 years through dedicated statistical and spectral analysis. Siemens Healthineers will be offering the Echos Plus, Echostation, and Echohybrid Plus models. For more information, visit the Echolight booth #1853 at the RSNA Annual Meeting. Echolight was established in Italy with head office in Lecce, and in 2020 opened its offices in the United States. Since then, its sales network has grown to more than 40 distributors and several hundreds of satisfied customers across the world who have adopted the innovative R.E.M.S. technology for assessing the bone condition of their patients. Created as a spin-off of the Italian National Research Council, Echolight is at the forefront of medical innovation, introducing new cutting-edge solutions to contribute to human wellbeing. It has been awarded all the standard certificates: UNI CEI EN ISO 13485: 2016, Quality Management System UNI EN ISO 9001: 2015, CE mark, FDA clearance, and other major certificates worldwide for innovative solutions considered as the best practice in bone health for personalized medicine. SOURCE Echolight Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

放射疗法

2024-11-18

·医药健闻

跨国药企在中国 | 强生、默沙东、诺华、罗氏、雅培、BI、诺和诺德、卡尔史托斯、富士胶片、奥林巴斯、住友制药、参天等新动态

跨国药企在中国重点资讯文 | 卓悦药企动态诺华诺华中国与中国麻风防治协会宣布签署战略合作备忘录。双方将整合优势资源，在皮肤科领域的学术交流、疾病控制、临床科研、人才培养以及公益科普等方面全面发力，以专科发展带动防治能力提升，防病治病、惠及大众，助力实现全面消除麻风危害的目标，推动我国皮肤健康事业迈向新的高度。罗氏罗氏诊断中国总部新办公室正式启用，同时，罗氏诊断中国技术创新中心(Technical Innovation Center，简称TIC)获得了上海浦东新区大企业开放创新中心授牌。依托TIC，罗氏诊断将加速推进体外诊断新技术的临床验证和成果转化、数字化及创新诊疗方案试点与应用、体外诊断产品商业化、加速伴随诊断合作等领域的创新合作成果落地。总部新办公室融合了灵活办公、多元包容、可持续发展等设计理念，打造了充满活力、开放协作的现代化办公空间。勃林格殷格翰勃林格殷格翰与中国卒中学会共同宣布就"BOAT行动"达成合作伙伴关系。依托这一项目，双方计划在未来携手提升中国缺血性卒中的救治水平，重点着力于提高中国缺血性卒中患者的再灌注治疗应用率，从而降低卒中致残率，提高患者生活质量。强生强生公司宣布其外科业务将进行一系列组织架构调整和人事变动。自2025年1月1日起，外科事业部将进行重组，主要由微创与能量外科事业部、伤口闭合事业部、生物外科事业部、外科全产品拓展事业部(即广域市场事业部)、战略市场部以及机器人与数字化六大部门组成。鹏瑞利首家外商独资医院落地广州。新加坡鹏瑞利集团与广州市白云区政府签订合作协议，将投资 50 亿元在广州打造占地 1.18 平方公里的「粤港澳大湾区白云国际大健康医养城」。今年 9 月 7 日，商务部、国家卫生健康委、国家药监局共同发布《关于在医疗领域开展扩大开放试点工作的通知》，拟允许在北京、天津、上海、南京、苏州、福州、广州、深圳和海南全岛设立外商独资医院。这次首期投资10亿元打造的鹏瑞利国际医院，计划于 2025 年建成投入使用。这家医院，也有望成为新通知发布以来，全国首家新设的外商独资医院。奥林巴斯奥林巴斯(OLYMPUS)在中国销售的内窥镜等主力产品将开始在当地组装。奥林巴斯正在为苏州的新工厂投产做准备。中国的医疗机构纷纷优先采购国内生产的产品，为此奥林巴斯决定将组装环节转移到中国当地。工厂的建设和生产设备的安装已经完成，正在为启动量产办理相关手续。购买在中国国内生产的产品有优惠，奥林巴斯希望通过启动当地工厂，提升销售业绩。奥林巴斯在中国柔性内窥镜市场上占有7成以上的市场份额。在奥林巴斯的合并销售额中，中国业务占比超过1成。住友制药住友制药与上海华东师范大学附属卢湾辅读实验学校再次携手，共同开展了一场以"儿童用药安全"为主题的科普教育活动。本次活动旨在通过趣味科普和互动游戏，引导孩子们正确理解药物的作用，学习安全用药的知识，从而提升他们的用药安全意识。产业动态默沙东动物保健宣布其圆支二联疫苗圆安克在中国正式商业上市。该疫苗针对猪圆环病毒2型(PCV2)和猪支原体肺炎(M hyo)，为国内养殖企业提供高质量解决方案。接种该疫苗可提升猪只生产性能并降低成本，每头猪平均增加63.88元收益。圆安克采用欧洲专利技术，确保安全性与有效性。默沙东(MSD)以5.88亿美元的预付款，外加高达27亿美元的里程碑付款，从礼新医药(LaNova Medicines)获得了一种实验性癌症抗体的授权。与礼新医药的交易推动了默沙东进入双靶向抗体这一有前景的新领域。根据该协议，该公司将获得LM-299的全球独家权益，LM-299是一种所谓的双特异性抗体，可以通过多种方式对抗癌症。该药物目前正在中国进行一期临床试验。礼新医药是一家立足中国，面向全球的临床阶段创新药研发公司。 SCIEX宣布在中国本土化生产Triple Quad 6500+系统和QTRAP 6500+系统。自2023年在苏州成功交付本土化Triple Quad 4500系统、QTRAP 4500系统和5500+系列质谱以来，6500+系列高端质谱的两个型号也已实现中国生产。6500+系统是SCIEX高端三重四极杆/QTRAP质谱产品，在复杂基质中提供卓越分析灵敏度，具备快速极性切换和多反应监测速度，可提高检测通量。百欧恩泰(BioNTech)将向总部位于广东省的制药商普米斯支付8亿美元预付款，之后支付最高1.5亿美元的里程碑付款。该公司相信普米斯研发的药物“有潜力超越传统的检查点抑制剂，在多种肿瘤适应症领域建立新的治疗标准”。此次收购是西方制药商转向中国公司以利用创新成果(而且往往成本更低)的最新案例。默沙东、葛兰素史克(GSK)和阿斯利康(AstraZeneca)去年均在中国达成许可协议，构成外资对中国生物技术公司创纪录的441亿美元全年投资的一部分。雅培不断引入全球前沿的技术解决方案，助力中国检验医学加速发展；通过持续深入本土化战略，深耕中国满足更广阔的医疗发展需求。旗下两款重磅智能化解决方案——免疫模块 Alinity i 和自动化流水线 GLP，宣布实现中国本地化生产之后，在11月6日迎来首条国产化流水线 GLP 的正式交付。自动化流水线 GLP 从提升样本周转时间、确保准确临床决策、降低人员工作强度以及充分利用场地空间等多个维度满足实验室日益增长的需求。诺和诺德宣布，全球首个且目前唯一用于长期体重管理的胰高糖素样肽-1受体激动剂(GLP-1RA)周制剂诺和盈正式在中国上市。诺和盈(用于长期体重管理的司美格鲁肽注射液)能够实现平均约17%的体重降幅，并为患者带来超越减重的多重健康获益。德国默克制药计划向中国提交抗癌药物申请。德国默克公司(Merck KGaA)针对腱鞘巨细胞瘤患者的实验性治疗在3期研究中达到主要终点，该公司计划与上海合作伙伴和誉生物一起将该药提交中国审批。腱鞘巨细胞瘤是一种罕见的良性肿瘤，是“年轻人的疾病”。因为它们生长在关节内部和周围，会导致肿胀、疼痛、僵硬和活动受限。2023年12月，和誉医药与德国默克医药健康达成许可协议，授予其在中国大陆、香港、澳门和台湾地区的独家商业化许可，以及匹米替尼全球商业权利的独家选择权。全球医疗技术公司卡尔史托斯宣布其首批国产内窥镜影像产品已正式获得中华人民共和国医疗器械注册证。本次获批的产品，全部由卡尔史托斯上海制造基地生产制造，涵盖内窥镜摄像主机、影像模块及摄像头等共8款产品，均为卡尔史托斯的核心影像产品，将优先满足中国市场的需求。参天制药与极目生物就眼科疗法ARVN001开展商业化合作。参天制药与极目生物宣布，极目生物将其正在研发中的ARVN001在中国内地的独家商业化权益授权于参天制药。ARVN001采用脉络膜上腔微注射专利技术，将用于治疗葡萄膜炎性黄斑水肿和其他一些正在开发中的潜在眼科适应症。 LG化学独家代理的 "便携式低温治疗仪(商品名：Target Cool)"成功获得NMPA批准。Target Cool作为已获得美国FDA认证及欧洲CE认证的快速精密冷却医疗器械，可快速精准地冷却皮肤，实现即刻麻醉效果，首次开启精准低温冷疗在医疗美容领域的探索，引领多元化舒适诊疗新纪元。中华医学会第31次放射学学术大会在上海开幕。富士胶片(中国)投资有限公司放射产品事业部以"Open领航大放奕彩"为主题进行了全系列放射产品的展示，包含新型X射线透视摄影系统、新型CT设备、数字化乳腺X射线诊断系统等。在CCR2024会议期间，富士胶片放射产品团队成员与参会者展开了富有成效的交流和互动，详尽解答了他们关于产品技术细节和应用场景的咨询。相关阅读：跨国药企在中国 | 罗氏、诺华、勃林格殷格翰、拜耳、梯瓦、默沙东、艾尔建、GE医疗、爱德华、波科、万益特、武田、卫材等新动态跨国药企在中国 | 强生、辉瑞、礼来、美敦力、艾尔建、罗氏、GSK、阿斯利康、西门子医疗、飞利浦、蔡司、依视路陆逊梯卡等新动态联系美通社 +86-10-5953 9500 info@prnasia.com

带量采购

2024-11-13

·思齐俱乐部

国家卫健委召集24家药企开会，研讨合规学术会议等问题（附名单）

据国家卫健委网站，11月12日，国家卫生健康委在京召开医药企业座谈会，听取对当前医药产业发展形势和下一步工作的意见建议。委党组书记、主任雷海潮出席会议并讲话。此次会议不仅聚焦于当前医药产业的发展形势，还重点研究了合规学术会议、合规领取讲课费等问题。会议强调，鼓励医药企业发挥中外交流的桥梁纽带作用，在构建人类卫生健康共同体方面担当作为。支持引导学术交流合作规范开展，合规开展营销，共同打造风清气正的行业生态。据了解，本次共有24家医药企业参加了座谈会，重点研究了以下六个方面的内容：一、支持医疗数据脱敏共享推进医药产品研发、上市使用后效果监测等政策措施，目前的工作方向和重点。医疗人工智能和数字化的发展重点。二、支持创新药品、诊疗手段、器械相关标准制定工作的简要情况和下一步工作重点。三、支持商业保险发展推进高端医药产品应用，推进创新药进医院等工作部署和重点。四、支持开展特需医疗、高质量临床试验的有关情况和工作重点。五、支持医务人员合规参加中外医药企业学术会议、合规领取讲课费，营造风清气正学术交流环境的有关进展和要求。六、支持中外企业参与医药科技创新、临床研究的有关进展和工作重点。合规学术会议一直是医药行业的热点话题。近年来，随着医药行业的快速发展，学术会议的数量和规模也在不断扩大。然而，一些学术会议却存在着违规发放讲课费、虚报参会人数等问题，严重损害了行业的形象和公信力。为此，国家卫健委在此次座谈会上明确要求，医药企业应严格遵守国家法律法规和行业规范，确保学术会议的内容合法合规，不涉及任何违法违规行为。同时，医务人员在参加学术会议时，也应严格遵守相关规定，不得利用学术会议谋取私利或进行不正当交易。针对合规领取讲课费的问题，国家卫健委也提出了明确要求。讲课费作为医务人员参与学术会议的重要收入来源之一，其合规性一直备受关注。为防止讲课费成为违规行为的“遮羞布”，国家卫健委要求医药企业应建立完善的讲课费管理制度，明确讲课费的发放标准和流程，确保讲课费的发放符合相关法律法规和行业规范。参加企业名单： 1、国药集团 2、华润医药集团有限公司 3、江苏恒瑞医药股份有限公司 4、石药控股集团有限公司 5、北京万泰生物药业股份有限公司 6、云南沃森生物技术股份有限公司 7、北京同仁堂（集团）有限责任公司 8、江苏康缘药业股份有限公司 9、上海联影医疗科技股份有限公司 10、长木谷医疗科技股份有限公司 11、迈瑞医疗国际股份有限公司 12、东软医疗系统股份有限公 13、辉瑞公司 14、罗氏集团 15、拜耳集团 16、诺和诺德公司 17、诺华集团 18、礼来公司 19、默沙东公司 20、赛诺菲巴斯德公司 21、葛兰素史克公司 22、飞利浦医疗有限公司 23、通用电气医疗有限公司 24、西门子医疗系统有限公司来源：思齐俱乐部作者：李思齐编辑：xiaowei 图片来源：国家卫健委网站商务合作 130 6172 3098 zakk.cui@siqibest.com 点击阅读原文了解更多

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