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飞利浦Zenition 30移动C形臂获得FDA 510(k) 许可

Philips Receives FDA 510(k) Clearance on Image-Guided Surgical Therapy

HIT | 2024-04-24 | 翻译由动脉网AI生成,点击反馈

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What You Should Know:

您应该知道:

–              Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced its Philips Zenition 30 mobile C-arm has received FDA 510(k) clearance, making image-guided surgical procedures available to more US patients at lower cost.

–全球卫生技术领导者皇家飞利浦(纽约证交所:PHG,AEX:PHIA)今天宣布,其飞利浦Zenition 30移动C臂已获得FDA 510(k)许可,使更多美国患者可以以更低的成本使用图像引导外科手术。

–              By giving surgeons greater flexibility, control, and personalization of C-arm movement and user settings, Zenition 30 reduces their dependency on support personnel, helping alleviate staff shortages that limit patient access and increase waiting times.

–Zenition 30为外科医生提供了更大的灵活性、控制和个性化的C形臂运动和用户设置,减少了他们对支持人员的依赖,有助于缓解限制患者访问和增加等待时间的人员短缺。

Advanced Imaging and Control with Zenition 30

使用Zenition 30进行高级成像和控制

Enhanced Workflow and Budgetary Relief: The Zenition 30 addresses both budgetary constraints and workflow efficiency in hospitals by reducing the need for support staff during procedures. Surgeons can treat more patients while dedicating more time to each, improving both patient and staff experiences..

增强的工作流程和预算救济:Zenition 30通过减少手术过程中对支持人员的需求,解决了医院的预算限制和工作流程效率。外科医生可以治疗更多的患者,同时为每个患者投入更多的时间,改善患者和员工的体验。。

Superior Imaging with Dose Efficiency: Incorporating Philips’ latest flat detector technology and advanced imaging algorithms, Zenition 30 ensures superior image quality while minimizing X-ray exposure for patient and staff safety. Personalized user profiles and automatic workflow customization streamline procedures, reducing manual adjustments and improving imaging accuracy.

具有剂量效率的卓越成像:Zenition 30结合了飞利浦最新的平板探测器技术和先进的成像算法,确保了卓越的图像质量,同时最大程度地减少了X射线曝光,确保了患者和员工的安全。个性化用户配置文件和自动工作流定制简化了程序,减少了手动调整并提高了成像精度。

Philips BodySmart software further enhances image consistency, particularly when targeting off-center anatomy..

飞利浦BodySmart软件进一步增强了图像的一致性,特别是在针对非中心解剖结构时。。

Tailored Features for Specific Needs: Philips MetalSmart software adjusts image contrast and brightness for patients with metal implants, maintaining image quality while minimizing X-ray dose. Pediatric mode reduces dose rates for young patients. The system’s digital subtraction angiography capability enables clear imaging of vasculatures, enhancing its utility across a wide range of surgical procedures..

针对特定需求量身定制的功能:飞利浦MetalSmart软件为金属植入物患者调整图像对比度和亮度,保持图像质量,同时最大程度地减少X射线剂量。儿科模式降低了年轻患者的剂量率。该系统的数字减影血管造影功能可以对血管进行清晰的成像,从而增强其在各种外科手术中的实用性。。

Enhanced Surgeon Control: With easily accessible pushbuttons on the flat detector, surgeons can control C-arm positioning during procedures, eliminating the need for manual effort to release and apply brakes. Usability studies show high confidence in the system’s enhanced control and personalized imaging profiles, indicating potential for greater independence and reduced image capture requirements during procedures..

增强的外科医生控制:通过平板探测器上易于接近的按钮,外科医生可以在手术过程中控制C臂的位置,无需手动释放和施加制动器。可用性研究表明,该系统的增强控制和个性化成像配置文件具有很高的可信度,这表明在操作过程中有可能获得更大的独立性并降低图像捕获要求。。

Innovative Mobile Platform: The Zenition mobile C-arm platform consolidates advancements in image capture, processing, ease-of-use, and versatility, building upon Philips’ successful Zenition platform. Royal Philips is committed to leveraging health technology to improve people’s health and well-being through meaningful innovation, offering personal and professional health solutions for both hospital and home settings..

创新的移动平台:Zenition Mobile C-arm平台巩固了飞利浦成功的Zenition平台在图像采集、处理、易用性和多功能性方面的进步。皇家飞利浦致力于利用健康技术,通过有意义的创新来改善人们的健康和福祉,为医院和家庭环境提供个人和专业的健康解决方案。。

“Based on our Zenition platform’s proven ease of use and workflow efficiency, the new Zenition 30 offers a unique combination of personalized control and image clarity to enhance the speed and accuracy of decision making for a range of clinical procedures at a price point that meets today’s economic and business goals,” said Mark Stoffels, General Manager Philips Image Guided Therapy Systems..

飞利浦图像引导治疗系统总经理马克·斯托费尔斯(Mark Stoffels)表示:“基于我们的Zenition平台经验证的易用性和工作流程效率,新的Zenition 30提供了个性化控制和图像清晰度的独特组合,以满足当今经济和商业目标的价格,提高了一系列临床程序的决策速度和准确性。”。。

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