Heidelberg Engineering, a leader in ophthalmic imaging and healthcare data solutions, has announced FDA clearance for the SPECTRALIS® Flex Module. This innovative multimodal platform is specifically designed for diagnostic imaging of the posterior segment in both pediatric and adult patients while they are in a supine position.
Heidelberg Engineering has introduced the SPECTRALIS® Flex Module, which has received FDA clearance. This innovative diagnostic imaging platform features a movable stand with an adjustable arm, allowing unprecedented flexibility for imaging the posterior segment in both pediatric and adult patients positioned supine. This design is particularly advantageous for patients who cannot be accommodated by traditional tabletop OCT devices.
“We are thrilled to receive FDA clearance for the SPECTRALIS Flex Module, which aligns with our mission to provide Heidelberg’s high-quality imaging to all patients, regardless of age or physical condition,” said Ram Liebenthal, General Manager US at Heidelberg Engineering. “By reimagining the SPECTRALIS in a more adaptable setup, we ensure that even patients who struggle with static, table-mounted systems can access top-tier imaging, providing reassurance to parents and caregivers.”
The Flex Module offers a range of imaging modalities similar to the traditional SPECTRALIS, 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 facilitates convenient examinations for all patients.
Lejla Vajzovic, MD, FASRS, the principal investigator of the clinical trial, noted, “The Flex Module has proven essential for diagnosing patients who are otherwise difficult to image. Its superior image quality captures fine details crucial for accurate diagnosis and treatment planning. For those in a supine position, the ability to detect macular and optic nerve pathologies is vital for providing timely, sight-saving interventions.”
The SPECTRALIS Flex Module will be featured at the Heidelberg Engineering exhibition stand (#4444) during the American Academy of Ophthalmology Congress in Chicago from October 19-21, 2024.
About Heidelberg Engineering
Heidelberg Engineering focuses on enhancing imaging and healthcare IT technologies to deliver ophthalmic diagnostic solutions that empower clinicians to improve patient care. Since its founding in 1990, the company has worked alongside scientists, clinicians, and industry partners to develop innovative products that offer clinically significant benefits.
The company’s commitment to uncompromising quality and education fosters the diagnostic confidence associated with its global brand. Heidelberg Engineering combines its expertise in intelligent image and data management with a rich history in designing, manufacturing, and distributing ophthalmic diagnostic instruments. Its expanding product portfolio integrates core technologies such as 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.
