FRANKLIN, Mass.--(BUSINESS WIRE)--Heidelberg Engineering, a global leader in ophthalmic imaging and healthcare data solutions, announces FDA clearance of the SPECTRALIS® Flex Module. This innovative, multimodal, diagnostic imaging-only platform is uniquely designed for imaging the posterior segment of pediatric and adult patients in a supine position..

马萨诸塞州富兰克林市——（商业新闻短讯）——全球眼科成像和医疗保健数据解决方案领导者海德堡工程公司宣布FDA批准SPECTRALIS®Flex模块。这种创新的多模式诊断成像平台是专为仰卧位儿科和成人患者的后段成像而设计的。。

The Flex Module mounts the renowned SPECTRALIS to a movable stand with an articulated adjustable arm, offering unprecedented flexibility that extends imaging capabilities to various positions and acquisition environments. This is particularly beneficial for patients who cannot be imaged with traditional tabletop OCT devices..

Flex模块将著名的SPECTRALIS安装到带有铰接式可调臂的可移动支架上，提供前所未有的灵活性，将成像能力扩展到各种位置和采集环境。这对于无法使用传统桌面OCT设备成像的患者尤其有益。。

“Receiving FDA clearance for the SPECTRALIS Flex Module fulfills our vision of bringing Heidelberg image quality to all patients, regardless of their age or physical abilities,” says Ram Liebenthal, General Manager US at Heidelberg Engineering. “We recognized that many patients cannot use a static, table-mounted headrest.

海德堡工程公司美国总经理拉姆·利本索尔（RamLiebenthal）表示：“SPECTRALIS Flex模块获得美国食品和药物管理局（FDA）的批准，实现了我们为所有患者提供海德堡图像质量的愿景，无论他们的年龄或身体能力如何。我们认识到，许多患者不能使用静态的台式头枕。

By reimagining SPECTRALIS in a more flexible configuration, we can ensure that these patients have access to best-in-class imaging, offering peace of mind to parents, guardians, and caretakers.”.

通过以更灵活的配置重新想象SPECTRALIS，我们可以确保这些患者能够获得一流的成像，为父母，监护人和看护者提供安心。”。

Similar to the traditional tabletop SPECTRALIS device, the Flex Module offers various imaging- only modalities, including high-resolution OCT, OCT Angiography (OCTA), Fluorescein Angiography (FA), Indocyanine Green Angiography (ICG), Blue Laser Autofluorescence, MultiColor, and both Widefield and Ultra-Widefield imaging.

与传统的桌面SPECTRALIS设备类似，Flex模块提供各种仅成像模式，包括高分辨率OCT，OCT血管造影（OCTA），荧光素血管造影（FA），吲哚青绿血管造影（ICG），蓝色激光自发荧光，多色，以及宽场和超宽场成像。

This multimodal imaging approach helps ensure convenient examinations for all patients..

这种多模式成像方法有助于确保对所有患者进行方便的检查。。

Lejla Vajzovic, MD, FASRS, principal investigator of the clinical trial, remarked, 'The Flex Module has been an indispensable diagnostic tool for patients who would otherwise be difficult to image. Its exceptional image quality allows me to capture the fine details essential for precise diagnosis and treatment planning.

该临床试验的首席研究者、FASRS医学博士Lejla Vajzovic表示，“Flex模块对于那些难以想象的患者来说是不可或缺的诊断工具。。

For patients in a supine position, the ability to detect macular and optic nerve pathologies ensures that these vulnerable individuals receive timely, sight-saving treatments.'.

对于仰卧位的患者，检测黄斑和视神经病变的能力确保了这些脆弱的个体得到及时的，节省视力的治疗。”。

The SPECTRALIS Flex Module will be showcased at the Heidelberg Engineering exhibition stand (#4444) during the American Academy of Ophthalmology Congress in Chicago, October 19-21, 2024.

2024年10月19日至21日，在芝加哥举行的美国眼科学会大会期间，SPECTRALIS Flex模块将在海德堡工程展台（#4444）展出。

About Heidelberg Engineering

关于 Heidelberg Engineering

Heidelberg Engineering continuously optimizes imaging and healthcare IT technologies to provide ophthalmic diagnostic solutions that empower clinicians to improve patient care. From its inception in 1990, the company has collaborated with scientists, clinicians, and industry to develop innovative products that deliver clinically relevant benefits..

海德堡工程不断优化成像和医疗保健IT技术，以提供眼科诊断解决方案，使临床医生能够改善患者护理。自1990年成立以来，该公司一直与科学家、临床医生和业界合作，开发具有临床相关益处的创新产品。。

Uncompromising quality and education play a large part in fostering the diagnostic confidence that has become synonymous with the global brand. The company’s substantial expertise in the development and implementation of intelligent image and data management solutions complements its distinguished history in the design, manufacture, and distribution of ophthalmic diagnostic instruments..

不妥协的质量和教育在培养诊断信心方面发挥了重要作用，而诊断信心已成为全球品牌的代名词。该公司在智能图像和数据管理解决方案的开发和实施方面的丰富专业知识，补充了其在眼科诊断仪器的设计、制造和分销方面的杰出历史。。

Heidelberg Engineering’s growing product portfolio combines these core technologies: confocal microscopy, scanning lasers and optics, optical coherence tomography (OCT), real-time image processing and analytics, multimodal image management solutions (PACS), electronic medical records (EMR), and large-scale data analysis..

海德堡工程不断增长的产品组合结合了以下核心技术：共聚焦显微镜、扫描激光和光学、光学相干断层扫描（OCT）、实时图像处理和分析、多模式图像管理解决方案（PACS）、电子病历（EMR）和大规模数据分析。。