FDA Grants Clearance for SPECTRALIS Flex Module, Expanding Access to Advanced Multimodal Ophthalmic Imaging for Underserved Patients

Barchart · 10/14 13:02

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.

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The SPECTRALIS Flex Module attaches the SPECTRALIS to a movable stand with an adjustable arm, providing enhanced flexibility and ease of positioning for patients in the supine position. (Photo: Business Wire)

The SPECTRALIS Flex Module attaches the SPECTRALIS to a movable stand with an adjustable arm, providing enhanced flexibility and ease of positioning for patients in the supine position. (Photo: Business Wire)

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.

“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. 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.”

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

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. 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."

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.

For more information about SPECTRALIS Flex Module contact us directly.

About 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.

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.

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.