Heidelberg Engineering Gains FDA Clearance for the SPECTRALIS Flex Module

The U.S. Food and Drug Administration has cleared Heidelberg Engineering’s SPECTRALIS Flex Module. The multimodal, diagnostic imaging-only platform is designed for imaging the posterior segment of pediatric and adult patients in a supine position.

The Flex Module mounts SPECTRALIS to a movable stand with an articulated adjustable arm, offering unprecedented flexibility that extends imaging capabilities to various positions and acquisition environments, according to the company. This is particularly beneficial for patients who cannot be imaged with traditional tabletop optical coherence tomography (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,” said Ram Liebenthal, general manager, U.S., 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 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, Indocyanine Green Angiography, Blue Laser Autofluorescence, MultiColor, and both Widefield and Ultra-Widefield imaging. This multimodal imaging approach helps ensure convenient examinations for all patients.

“The Flex Module has been an indispensable diagnostic tool for patients who would otherwise be difficult to image,” Lejla Vajzovic, M.D., clinical trial principal investigator, stated. “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.”

Heidelberg Engineering continuously optimizes imaging and healthcare IT technologies to provide ophthalmic diagnostic solutions that empower clinicians to improve patient care. From its 1990 inception, the company has collaborated with scientists, clinicians, and industry to develop products that deliver clinically relevant benefits. Heidelberg Engineering’s growing product portfolio combines these core technologies: confocal microscopy, scanning lasers and optics, OCT, real-time image processing and analytics, multimodal image management solutions, electronic medical records, and large-scale data analysis.