SonoClear AS公司获得FDA突破性认定，用于SonoClear®系统-动脉网

SonoClear AS Receives FDA Breakthrough Designation for SonoClear® System

CISION 等信源发布 2025-07-01 21:00

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可切换为仅中文

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Innovative Fluid Designed to Assist in Ultrasound-Guided Surgical Resection

创新液体设计用于辅助超声引导下的手术切除

of Brain Tumors -

脑肿瘤 -

First Fully Norwegian Owned Company to be Granted Breakthrough Device Designation -

首家获得突破性设备指定的全挪威拥有公司 -

OSLO, Norway

挪威奥斯陆

，

July 1, 2025

2025年7月1日

/PRNewswire/ -- SonoClear AS today announced that the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has designated the SonoClear

/PRNewswire/ -- SonoClear AS今天宣布，美国食品药品监督管理局（FDA）的设备和放射健康中心（CDRH）已指定SonoClear

System as a Breakthrough Device for use in intracranial ultrasound procedures.

系统作为一种用于颅内超声程序的突破性设备。

The SonoClear System is an acoustic coupling fluid and sterile transfer kit, engineered to address a critical limitation of conventional intraoperative imaging during neurosurgical interventions. The SonoClear System's tissue-mimicking properties remove the acoustic artifacts that appear when using standard irrigation fluids as a couplant and which typically obscure critical tumor remnants at the base of a resection cavity.

SonoClear系统是一种声学耦合流体和无菌传输套件，旨在解决神经外科手术中传统术中成像的一个关键限制。SonoClear系统的组织模拟特性消除了使用标准冲洗液作为耦合剂时出现的声学伪影，这些伪影通常会掩盖切除腔底部的关键肿瘤残留。

The SonoClear System was developed, and is wholly owned, by SonoClear, a company founded to improve diagnostic accuracy in ultrasound-guided interventions..

SonoClear 系统由 SonoClear 公司开发，并且完全归其所有，该公司旨在提高超声引导介入诊断的准确性。

'Removing aggressive neurological tumors, such as gliomas, presents a significant surgical challenge,' said Prof. Geirmund Unsgaard, neurosurgeon and SonoClear founder. 'In brain tumor surgery, neurosurgeons rely on intraoperative ultrasound to guide their work and confirm complete tumor removal. Standard irrigation fluids create visual artifacts that can obscure the surgical site precisely when clarity is most critical: at the end of the procedure when surgeons need to verify whether any tumor remains.

“切除侵袭性神经胶质瘤（如胶质瘤）是一项重大的外科挑战，”神经外科医生、SonoClear创始人盖尔蒙德·昂斯加德教授表示。“在脑肿瘤手术中，神经外科医生依靠术中超声来指导他们的工作并确认肿瘤完全切除。标准冲洗液会产生视觉伪影，可能在最关键的时刻遮挡手术部位：即在手术结束时，当外科医生需要确认是否有残留肿瘤时。”

We created a simple solution that works with all intraoperative ultrasound systems and allows neurosurgeons to clearly see the tumor, enabling improved decision-making in surgery.'.

我们创建了一个与所有术中使用的超声系统兼容的简单解决方案，可以让神经外科医生清晰地看到肿瘤，从而帮助改善手术中的决策。

SonoClear recently closed an oversubscribed investment round. The company is sufficiently funded to support final product testing and clinical evaluations required for the FDA

SonoClear最近完成了一轮超额认购的投资。公司有足够的资金支持FDA所需的最终产品测试和临床评估。

510k

submission, as well as market conditioning activities in the U.S. and

提交，以及在美国的市场调节活动和

Europe

欧洲

upon regulatory clearance.

在获得监管批准后。

SonoClear's CEO,

SonoClear的首席执行官，

Peter Balmforth

彼得·巴尔姆福德

, commented, 'With breakthrough designation, the FDA recognizes a select number of devices with the potential to positively impact patients facing life-threatening conditions. We are encouraged by early phase I data, which demonstrated SonoClear System's ability to deliver improved image clarity. We are currently conducting additional clinical investigations to evaluate SonoClear System against the current standard of care.

，评论道：“通过突破性认定，FDA认可了少数具有对面临生命威胁的患者产生积极影响潜力的设备。我们受到早期第一阶段数据的鼓舞，这些数据展示了SonoClear系统提供更清晰图像的能力。我们目前正在开展更多的临床研究，以评估SonoClear系统与当前护理标准的对比。”

Our team is energized to finalize the .

我们的团队充满活力，准备完成这项工作。

510k

submission and bring this product one step closer to giving neurosurgeons real-time, high-definition image quality to better guide tumor resection.'

提交并将该产品更进一步，以提供给神经外科医生实时的高清图像质量，更好地引导肿瘤切除。

Prof.

教授

Francesco DiMeco

弗朗切斯科·迪梅科

, neurosurgical specialist at the Neurological Institute Carlo Besta in

，卡洛·贝斯塔神经学研究所的神经外科专家

Italy

意大利

, world-renowned intraoperative ultrasound expert, and a principal investigator in studies of the SonoClear System, said, 'Toward the end of a resection, with SonoClear fluid in the cavity, I could clearly see whether there was any tumor remnant, which is not always the case when we use standard irrigation fluids as a couplant.

`, 世界知名的术中超声专家，SonoClear系统研究的首席研究员说：“在切除手术接近尾声时，使用SonoClear液体填充腔体，我可以清楚地看到是否有肿瘤残留，而使用标准冲洗液作为耦合剂时并不总是能够做到这一点。`

This gives me confidence that I can achieve a maximum safe resection using intraoperative ultrasound combined with the SonoClear System.'.

这让我有信心通过结合术中超声和SonoClear系统实现最大程度的安全切除。

About the SonoClear® System

关于SonoClear®系统

SonoClear System is an ultrasound acoustic coupling fluid for intracranial ultrasound procedures. It is biocompatible, bio-excretable, sterile, and unit-dose packaged. Its initial intended use is in intracranial ultrasound-guided surgical tumor resection. SonoClear System was engineered to match the acoustic properties of brain tissue.

SonoClear系统是一种用于颅内超声手术的超声声学耦合液。它具有生物相容性、可生物排泄、无菌且以单位剂量包装。其最初的预期用途是在颅内超声引导下的外科肿瘤切除术中使用。SonoClear系统经过专门设计，以匹配脑组织的声学特性。

This minimizes the bright signal artifacts and enhanced echogenicity that conventional irrigation fluids create, and which typically obscure ultrasound imaging in surgical cavities. Studies demonstrate that using SonoClear System with ioUS enhances the diagnostic accuracy of intraoperative imaging, potentially improving the extent of resection (EOR) and reducing residual disease.

这减少了传统冲洗液所产生的明亮信号伪影和增强的回声性，这些通常会模糊手术腔内的超声成像。研究表明，将SonoClear系统与术中超声（ioUS）结合使用可提高术中成像的诊断准确性，可能改善切除范围（EOR）并减少残留病灶。

The device is not yet available for sale..

该设备尚未上市销售。

About the Market Need

关于市场需求

Neurosurgical resection remains the primary treatment modality and standard of care for brain tumors, requiring precise intraoperative decision-making to optimize patient outcomes. Skilled neurosurgeons rely on high-quality imaging to make critical determinations about tumor margins and resection boundaries.

神经外科切除术仍然是脑肿瘤的主要治疗方式和护理标准，需要精确的术中决策以优化患者的预后。熟练的神经外科医生依靠高质量的影像来做出关于肿瘤边缘和切除边界的关键决定。

Intraoperative ultrasound (ioUS) provides real-time imaging and is widely available, yet its diagnostic accuracy is compromised by suboptimal imaging conditions. Standard irrigation fluids like saline (0.9%) and lactated Ringer's solution create acoustic artifacts and image quality variability because they were not designed for diagnostic optimization.

术中超声 (ioUS) 提供实时成像且广泛可用，但其诊断准确性因成像条件不佳而受到影响。标准冲洗液如生理盐水 (0.9%) 和乳酸林格氏液会产生声学伪影和图像质量变化，因为它们并非为诊断优化而设计。

These imaging constraints limit the clarity needed for precise tumor margin identification, hindering surgeons' ability to make optimal treatment decisions based on what they can visualize in the resection cavity. By improving the diagnostic accuracy of ioUS, an enhanced ultrasound acoustic coupling fluid would have the potential to support better surgical decision-making, contributing to improved survival outcomes, significantly delayed tumor recurrence, and reduced healthcare costs by helping minimize the need for repeat surgeries and adjunctive treatments..

这些成像限制降低了精确识别肿瘤边界所需的清晰度，阻碍了外科医生根据他们在切除腔中能够看到的内容做出最佳治疗决策的能力。通过提高ioUS（术中超声）的诊断准确性，一种增强的超声声学耦合液有望支持更好的手术决策，有助于改善生存结果、显著延缓肿瘤复发，并通过帮助减少再次手术和辅助治疗的需求来降低医疗成本。

About SonoClear AS

关于SonoClear AS

SonoClear was spun out of the Ultrasound and Image-Guided Therapy Centre in Trondheim,

SonoClear 从特隆赫姆的超声波和影像引导治疗中心分离出来，

Norway

挪威

to develop technology that improves diagnostic accuracy in ultrasound-guided interventions. The company has the support of majority shareholders SINTEF, Sarsia, CoFounder and Sparebank 1 SMN, along with family offices and private investors. For more information, please visit

开发提高超声引导介入诊断准确性的技术。公司得到大股东SINTEF、Sarsia、CoFounder和Sparebank 1 SMN，以及家族办公室和私人投资者的支持。欲了解更多信息，请访问

https://www.sonoclear.no

。

CONTACTS

联系人

Peter Balmforth

彼得·巴尔姆福德

CEO

首席执行官

peter@sonoclear.no

彼得@声之清.no

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