Ophthalmic imaging company Heidelberg Engineering has received US Food and Drug Administration (FDA) clearance for the SPECTRALIS Flex Module.
The platform specialises in multimodal diagnostic imaging. It is designed for imaging the posterior segment of paediatric and adult patients in a supine position.
The SPECTRALIS Flex Module attaches the SPECTRALIS system to a movable stand with an articulated, adjustable arm. This design offers flexibility, expanding imaging capabilities for various positions and acquisition environments.
According to Germany-based Heidelberg Engineering, its design is helpful for patients who cannot be scanned using traditional tabletop OCT devices.
Heidelberg Engineering US general manager Ram Liebenthal said: “Receiving FDA clearance for the SPECTRALIS Flex Module fulfils our vision of bringing Heidelberg image quality to all patients, regardless of their age or physical abilities.
“We recognised 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.”
The latest Flex Module provides various imaging-only modalities similar to the traditional tabletop SPECTRALIS.
These include high-resolution Fluorescein Angiography (FA), OCT, OCT Angiography (OCTA), Blue Laser Autofluorescence, Indocyanine Green Angiography (ICG), MultiColor, and both Widefield and Ultra-Widefield imaging.
The Ophthalmic imaging firm said that this multimodal imaging approach ensures convenient examinations for all patients.
SPECTRALIS Flex Module clinical trial principal investigator Lejla Vajzovic said: “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.”
In July, the ophthalmic imaging company secured FDA clearance for its SPECTRALIS OCTA Module with SHIFT technology.
In the same month, EssilorLuxottica announced the acquisition of an 80% stake in Heidelberg Engineering.
