The Max 3 features a direct injection from original contrast media vials,eliminating the need for syringe refilling.
Max 3具有直接从原始造影剂瓶中直接注射的功能,无需再用注射器注入。
Bracco Imaging’s US unit Bracco Diagnostics and German medical device manufacturer ulrich have announced 510(k)clearance from the US Food and Drug Administration(FDA)for the rapid exchange and syringeless injector,Max 3,which is designed for magnetic resonance imaging(MRI)procedures.
Bracco Imaging
美国子公司Bracco Diagnostics和德国医疗设备制造商ulrich宣布,用于磁共振成像(MRI)手术的快速交换无注射器Max 3已获得美国食品药品管理局(FDA)的510(k)许可。
Max 3 offers easy-to-manage and intuitive features,including direct injection from original contrast media vials,eliminating the need for syringe refilling.
Max 3具有易于管理和直观的特点,包括从原始造影剂瓶中直接注入,无需重新注入注射器。
Additionally,the absence of power cables enables flexible positioning within the MRI room,supporting a magnetic field strength of 50mT.
此外,由于没有电源线,因此可以在核磁共振成像室内灵活定位,支持50mT的磁场强度。
Its‘Easy-Click-Cassette flex’comes with SafeConnect,a dedicated connector for patient tubing that ensures contact protection and guards against retrograde contamination.
它的“Easy-Click-Cassette flex”配有安全连接(SafeConnect)功能,这是一种用于患者管道的专用连接器,可确保接触保护并防止逆行污染。
It can be used for up to 24 hours or with a maximum of 96 bottles of contrast media,enhancing the workflow and allowing technologists to focus more on patients during procedures.
它可使用长达24小时或最多96瓶造影剂,从而改进了工作流程,使技术人员在手术过程中能更专注于病人。
The Max 3 injector also claims to promote environmentally sustainable practices in radiology and is expected to decrease the amount of plastic waste generated in hospitals and help manage disposal costs.
Max 3注射器还声称能促进放射科的环境可持续发展,并有望减少医院产生的塑料垃圾数量,帮助管理处理成本。
Bracco Diagnostics sales and marketing senior vice-president Cosimo De Pinto said:“Today’s clearance marks a critical step in delivering the full suite of Bracco’s robust MRI portfolio.”
Bracco诊断公司销售与营销高级副总裁Cosimo De Pinto说:“今天的通过标志着Bracco公司在提供全套强大的磁共振成像产品组合方面迈出了关键一步"。
Bracco Imaging CEO and vice chairman Fulvio Renoldi Bracco said:“This clearance underscores Bracco’s commitment to pushing the boundaries of innovation in 2024 and beyond while implementing sustainable production in all aspects of our business model.
Bracco Imaging公司首席执行官兼副董事长Fulvio Renoldi Bracco说:“这项许可强调了Bracco公司在2024年及以后推动创新的承诺,同时在我们业务模式的各个方面实施可持续生产。
“At Bracco,we always strive for advancements,and it’s remarkable to see how innovative diagnostic imaging solutions have transformed the MRI industry.Each step gets us closer to redefining the standard of patient care to meet today’s clinical needs.”
“在Bracco,我们始终追求进步,看到创新的诊断成像解决方案如何改变核磁共振成像行业,我们感到非常了不起。每一步都让我们更接近重新定义患者护理标准,以满足当今的临床需求。”
In November 2023,Bracco signed a long-term strategic partnership with ulrich medical,aimed at introducing a Bracco-branded,MRI injector to the US market,with a focus on enhancing quality and efficiency for healthcare providers.
2023年11月,Bracco与ulrich medical签署了长期战略合作伙伴关系,旨在向美国市场推出Bracco品牌的核磁共振注射器,重点是提高医疗服务提供商的质量和效率。
In October 2020,Bracco Diagnostics launched the CardioGen-82 infusion system.
2020年10月,Bracco诊断公司推出了CardioGen-82输液系统。