Heidelberg Engineering, a leading provider of ophthalmic imaging and healthcare data solutions, has announced that the FDA has granted clearance for its SPECTRALIS® Flex Module. This advanced, multimodal imaging platform is specifically designed to perform diagnostic imaging of the posterior segment in both pediatric and adult patients positioned supinely. The Flex Module features the well-known SPECTRALIS mounted on a mobile stand with an adjustable articulated arm, providing exceptional flexibility for imaging in various positions and environments. This innovation is particularly advantageous for patients who cannot use conventional tabletop OCT devices.
Ram Liebenthal, General Manager US at Heidelberg Engineering, stated, “The FDA clearance for the SPECTRALIS Flex Module aligns with our vision of delivering Heidelberg’s image quality to all patients, regardless of age or physical limitations. We recognized that many patients struggle with static, table-mounted headrests. By reimagining the SPECTRALIS in a more adaptable configuration, we can provide these patients with access to top-tier imaging, offering reassurance to parents, guardians, and caregivers.”
Similar to the standard tabletop SPECTRALIS, the Flex Module provides a range of 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 approach ensures convenient examinations for all patients.
Dr. Lejla Vajzovic, MD, FASRS, the principal investigator of the clinical trial, noted, “The Flex Module has proven to be an invaluable diagnostic tool for patients who are otherwise challenging to image. Its outstanding image quality enables me to capture critical details necessary for accurate diagnosis and treatment planning. The ability to detect macular and optic nerve pathologies in supine patients ensures that these vulnerable individuals receive timely, sight-saving interventions.”
The SPECTRALIS Flex Module will be featured at Heidelberg Engineering’s exhibition stand (#4444) during the American Academy of Ophthalmology Congress in Chicago, taking place from October 19-21, 2024.
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.
