LAKE FOREST, Calif., April 29, 2024 /PRNewswire/ -- Single Pass, Inc. is proud to announce that its Class II Kronos biopsy closure device has received clearance from the U.S. Food and Drug Administration (FDA). The FDA has determined the device is substantially equivalent to predicate devices regarding its safety and effectiveness..

加利福尼亚州森林湖，2024年4月29日/PRNewswire/--Single Pass，Inc.自豪地宣布，其II级Kronos活检闭合装置已获得美国食品和药物管理局（FDA）的许可。FDA已经确定该设备在安全性和有效性方面基本等同于上游设备。。

Under the leadership of Bill Colone and its Board of Directors, the Single Pass team collaborated with their contract manufacturing partner, M4D, based in Lake Forest, CA to bring the Kronos device to market. The company previously achieved the CE Mark under the EU MDR regulations, as now the Kronos device is now commercially available globally..

在比尔·科隆及其董事会的领导下，Single Pass团队与位于加利福尼亚州森林湖的合同制造合作伙伴M4D合作，将Kronos设备推向市场。该公司之前根据欧盟MDR法规取得了CE标志，因为现在Kronos设备已在全球范围内上市。。

'We are thrilled to have received FDA clearance for our Kronos biopsy closure device,' said Bill Colone, Co-founder, and CEO of Single Pass. 'The Kronos device represents a significant advancement, offering healthcare professionals a reliable and efficient solution for post biopsy bleeding and improved patient care.'.

Single Pass联合创始人兼首席执行官比尔·科隆（BillColone）说：“我们很高兴能够获得FDA对我们的Kronos活检闭合装置的批准。Kronos装置代表了一项重大进步，为医疗保健专业人员提供了可靠有效的活检后出血解决方案，并改善了患者护理。”。

Mermaid Medical, the US distribution partner, is prepared to initiate sales in the US, ensuring immediate national access to this groundbreaking technology. This strategic partnership will facilitate widespread coverage for this innovative and unique technology ultimately benefiting patients and healthcare providers across the country.For more information about Single Pass and its innovative medical devices, please visit https://www.singlepass.co/.About Single Pass: Single Pass is a medical device company dedicated to developing an innovative solution to post biopsy bleeding, enhance patient care, and improve clinical outcomes.

美国分销合作伙伴美人鱼医疗（Mermaid Medical）准备在美国启动销售，确保全国立即获得这项突破性技术。这一战略伙伴关系将促进这一创新和独特技术的广泛覆盖，最终使全国的患者和医疗保健提供者受益。有关Single Pass及其创新医疗设备的更多信息，请访问https://www.singlepass.co/.AboutSingle Pass：Single Pass是一家医疗器械公司，致力于开发活检后出血的创新解决方案，增强患者护理，改善临床结果。

With a focus on precision and reliability, Single Pass strives to revolutionize the healthcare landscape through cutting-edge technology by safely cauterizing deep tissue through a guide needle, promising swift, easy, and safe biopsy procedures.For media inquiries, please contact:Bill ColoneCEOSingle Pass+1-602-618-3377376884@email4pr.comSOURCE Single Pass, Inc..

Single Pass专注于精确性和可靠性，通过引导针安全烧灼深层组织，致力于通过尖端技术彻底改变医疗保健领域，有望实现快速，简单和安全的活检程序。有关媒体查询，请联系：BillColoneceSingle Pass+1-602-618-3377376884@email4pr.comSOURCESingle Pass公司。