Piccolo Medical公司获得FDA对其第二代SmartPICC®技术的批准-动脉网

Piccolo Medical, Inc. Receives FDA Clearance for 2nd Generation SmartPICC® technology

CISION 等信源发布 2025-07-16 17:00

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SAN FRANCISCO

旧金山

，

July 16, 2025

2025年7月16日

/PRNewswire/ --

Piccolo Medical, Inc. (Piccolo),

皮科洛医疗公司 (Piccolo)，

a leading innovator in vascular access technology, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its next-generation SmartPICC® Stylet and PM2+™ System. This significant achievement marks a major leap forward in safe, efficient, and cost-effective peripherally inserted central catheter (PICC) placement, offering enhanced benefits for both patients and healthcare providers..

血管通路技术的领先创新者，今天宣布已获得美国食品药品监督管理局（FDA）的510(k)许可，可以将其下一代SmartPICC®探针和PM2+™系统投入市场。这一重大成就标志着在安全、高效且经济实惠的经外周插入中心静脉导管（PICC）放置方面迈出了重要一步，为患者和医疗保健提供者带来了更多益处。

The SmartPICC® technology provides real-time, accurate bedside catheter tip confirmation for PICCs by leveraging the patient's cardiac electrical activity. This well-established technique eliminates the need for confirmatory chest X-rays, streamlining the PICC confirmation procedure and reducing potential delays in patient care.

SmartPICC® 技术通过利用患者的心脏电活动，为PICC（经外周静脉置入中心静脉导管）提供实时、精确的床旁导管尖端定位。这种成熟的技术无需进行确认性胸部X光检查，简化了PICC确认流程，并减少了患者护理中可能出现的延误。

The SmartPICC® Stylet also incorporates Piccolo's proprietary ionic dilution technology for PICC navigation. This innovative feature provides clinicians with real-time guidance during catheter insertion, allowing for immediate detection of improper advancements through the vasculature..

SmartPICC® Stylet 还采用了 Piccolo 专有的离子稀释技术用于 PICC 导航。这一创新功能为临床医生在导管插入过程中提供实时引导，能够立即检测到血管系统中的不当推进。

'The landscape of PICC procedures in the U.S. has evolved, with catheter navigation systems becoming the undeniable standard of care,' stated

“美国的PICC手术格局已经演变，导管导航系统已成为无可争议的护理标准，”声明表示。

Augustus Shanahan

奥古斯都·沙纳汉

, CEO of Piccolo Medical, Inc. 'However, the widespread adoption of these systems has often come with a significant financial burden on our healthcare system. We are incredibly proud to introduce a comprehensive vascular access solution to the market that not only prioritizes patient safety and positive outcomes but also empowers hospitals to realize the true economic value of bedside PICC confirmation.'.

Piccolo Medical, Inc. 首席执行官表示：“然而，这些系统的广泛采用往往给我们的医疗系统带来了沉重的经济负担。我们非常自豪地向市场推出一种全面的血管通路解决方案，该方案不仅优先考虑患者的安全和积极的结果，还使医院能够实现床旁PICC确认的真正经济价值。”

As part of its commercial strategy, Piccolo Medical has partnered with Spectrum Vascular as the exclusive North American distributor of the SmartPICC® system. Spectrum Vascular is a leading provider of vascular access and medication management solutions to hospitals across the country.

作为其商业战略的一部分，皮科洛医疗已与光谱血管合作，由后者担任SmartPICC®系统在北美的独家经销商。光谱血管是全国范围内为医院提供血管通路和药物管理解决方案的领先供应商。

'At Spectrum Vascular, we are committed to always delivering leading vascular access solutions that improve outcomes and empower caregivers,' said

“在Spectrum Vascular，我们致力于始终提供改善治疗效果并赋能护理人员的领先血管通路解决方案，”

Ken Miller

肯·米勒

, CEO of Spectrum Vascular. 'By integrating Piccolo's SmartPICC® navigation technology into our offering, we're helping clinicians achieve greater accuracy and efficiency at the bedside - reducing complications and improving care. It's one more way we're working toward a world with fewer complications and better patient outcomes.'.

Spectrum Vascular首席执行官表示：“通过将Piccolo的SmartPICC®导航技术整合到我们的产品中，我们正在帮助临床医生在床旁实现更高的准确性和效率——减少并发症并改善护理。这是我们为实现一个并发症更少、患者预后更好的世界所做出的又一努力。”

Piccolo Medical is committed to advancing vascular access solutions that improve patient care and optimize healthcare delivery. The FDA clearance of the 2nd generation SmartPICC® System reinforces the company's position as a leader in innovative medical technology.

皮科洛医疗致力于推进血管通路解决方案，以改善患者护理并优化医疗交付。第二代SmartPICC®系统获得FDA批准，进一步巩固了该公司在创新医疗技术领域的领导地位。

About Piccolo Medical:

关于皮科洛医疗：

Piccolo Medical Inc. is a start-up medical device company located in

Piccolo Medical Inc. 是一家位于某地的初创医疗器械公司

San Francisco, CA.

加利福尼亚州，旧金山。

Piccolo was spun out of the Theranova medical device incubator and has been funded by private investors as well as prestigious grant awards from the National Institute of Health's National Institute of Aging. Piccolo received 510(k) clearance for the ECGuide™ Connector and PM2™ System in 2024.

皮科洛是从Theranova医疗设备孵化器中分离出来的，并且已经获得了私人投资者的资金支持，以及来自美国国立卫生研究院下属的国家老龄化研究所的享有盛誉的拨款。皮科洛在2024年获得了ECGuide™连接器和PM2™系统的510(k)许可。

Contact Info:

联系方式：

Email:

电子邮件：

info@piccolomedical.com

Web:

网页：

http://www.piccolomedical.com/

About Spectrum Vascular:

关于光谱血管：

Spectrum Vascular acquired the vascular access business of Cook Medical (2023) and Angiodynamics (2024). Continued innovation is at the heart of Spectrum Vascular's mission. By harnessing our deep industry expertise and the latest advancements in medical technology, we are committed to pushing the boundaries of what's possible in vascular access solutions.

Spectrum Vascular收购了Cook Medical（2023年）和Angiodynamics（2024年）的血管通路业务。持续创新是Spectrum Vascular使命的核心。通过利用我们深厚的行业专业知识和医疗技术的最新进展，我们致力于突破血管通路解决方案的可能性界限。

Our goal is to not only meet but exceed the evolving needs of healthcare providers and patients alike, ensuring superior outcomes and transformative care experiences..

我们的目标不仅是满足医疗保健提供者和患者不断变化的需求，而且要超越这些需求，确保卓越的成果和变革性的护理体验。

Contact Info:

联系方式：

Email:

电子邮件：

info@spectrumvascular.com

Web:

网页：

https://spectrumvascular.com

SOURCE Piccolo Medical

来源：皮科洛医疗

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