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SEATTLE--(BUSINESS WIRE)--Tasso, Inc., the leading provider of patient-centric clinical-grade blood collection solutions, today announced it received CE Mark certification for its Tasso+™ device, a convenient, virtually pain-free blood lancet that collects whole liquid blood samples. The CE Mark designation allows Tasso to offer its patient-centric, high-volume blood collection solution in the European Union (EU) market, which includes 28 member states, plus Iceland, Norway and Lichtenstein.
西雅图-(商业线)-塔索公司是以患者为中心的临床级采血解决方案的领先供应商,今天宣布获得Tasso的CE标志认证+™ 该装置是一种方便,几乎无痛的血液刺血针,可收集全血样本。CE标志标志标志允许Tasso在欧盟(EU)市场提供以患者为中心的大容量采血解决方案,其中包括28个成员国,以及冰岛,挪威和利希滕斯坦。
The CE Mark designation ensures a product has met all European Commission safety, health and environmental protection requirements..
CE标志标志标志确保产品符合欧盟委员会所有安全,健康和环境保护要求。。
The Tasso+ device received Class II 510(k) clearance from the U.S. Food and Drug Administration (FDA) in August 2022. With the CE Mark certification, Tasso+ now has achieved full clearance in the U.S. and the EU, making it the first device of its kind to do so.
Tasso+装置于2022年8月获得美国食品和药物管理局(FDA)的II类510(k)许可。通过CE标志认证,Tasso+现已在美国和欧盟获得全面许可,使其成为同类产品中的第一台。
“This designation is an important milestone for Tasso, allowing us to build upon the success of our CE Marked Tasso-M20 device and continue to expand our commercial footprint and reduce healthcare access barriers in Europe, where demand increasingly grows for patient-centric solutions,” said Ben Casavant, PhD, CEO and co-founder of Tasso.
“这一指定是Tasso的一个重要里程碑,使我们能够以CE标志的Tasso-M20设备的成功为基础,继续扩大我们的商业足迹,减少欧洲的医疗保健准入障碍,欧洲以患者为中心的需求日益增长解决方案,“Tasso首席执行官兼联合创始人Ben Casavant博士说。
“The Tasso+ CE Mark enables us to support the pharmaceutical industry, academic and government institutions on research and clinical initiatives, as well as accelerate access to remote testing and care for more patient populations. We are excited to expand our customer base in Europe.”.
“Tasso+CE标志使我们能够支持制药业,学术界和政府机构的研究和临床举措,并加速为更多患者群体提供远程测试和护理服务。我们很高兴扩大我们在欧洲的客户群“。
The Tasso+ device is a single-use blood lancing device for obtaining microliter capillary whole blood samples. Based on groundbreaking technology, Tasso+ allows for virtually painless blood samples to be collected remotely, with a user-friendly interface that boosts satisfaction and engagement.
Tasso+装置是用于获得微升毛细血管全血样品的一次性血液循环装置。基于开创性的技术,Tasso+允许远程收集几乎无痛的血液样本,具有用户友好的界面,可提高满意度和参与度。
The device can be used with compatible collection tubes to accelerate decentralized clinical trials for pharmaceutical companies, especially for pharmacokinetic and biomarker research endpoints. With a patient-centric collection process that overcomes care access barriers, Tasso+ enables underserved and understudied patient populations to participate in clinical trials.
该装置可与兼容的收集管一起使用,以加速制药公司的分散临床试验,特别是药代动力学和生物标志物研究终点。通过以患者为中心的收集过程克服了护理准入障碍,Tasso+使服务不足和研究不足的患者群体能够参与临床试验。
In addition, healthcare systems and physicians can use the Tasso+ device to make determinations on blood chemistries for their patients and expand access to care..
此外,医疗保健系统和医生可以使用Tasso+设备为患者确定血液化学成分,并扩大获得护理的机会。。
About Tasso
关于Tasso
Tasso is an emerging healthcare technology company that is transforming the traditional blood collection paradigm with a patient-centric approach. The company’s devices enable simple, convenient, and virtually painless blood collection for users. Tasso technology has the power to bring healthcare anywhere, any time.
Tasso是一家新兴的医疗保健技术公司,正在以患者为中心的方式改变传统的采血模式。该公司的设备为用户提供简单,方便且几乎无痛的血液采集。塔索技术有能力随时将医疗保健带到任何地方。
Headquartered in Seattle, Washington, Tasso is privately held and funded by grants, investments, and co-development deals with various industry leaders. For more information, please visit www.tassoinc.com..
塔索总部设在华盛顿州西雅图市,由私人持有,由赠款,投资和共同开发公司资助,与各行业领导者进行交流。欲了解更多信息,请访问www.tassoinc.com。。