Heidelberg Engineering Receives FDA Clearance for Spectralis Flex Module for Supine Imaging

Heidelberg Engineering has received FDA clearance for its Spectralis Flex Module, a multimodal diagnostic imaging platform. The new module is designed specifically for imaging the posterior segment of both pediatric and adult patients in a supine position, addressing a need for patients unable to use traditional tabletop devices.

The Spectralis Flex Module, which mounts the Spectralis system to a movable stand with an articulated, adjustable arm, brings flexibility to ophthalmic imaging. This adaptable design allows clinicians to perform high-quality imaging in various positions and settings, expanding diagnostic capabilities for patients who cannot be easily accommodated by standard imaging equipment, according to Heidelberg.

"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," Ram Liebenthal, General Manager of Heidelberg Engineering in the US, said in a company news release. "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.”

The Flex Module maintains the hallmark features of the traditional Spectralis device, offering a range of imaging-only modalities such as high-resolution optical coherence tomography (OCT), OCT angiography (OCTA), fluorescein angiography (FA), indocyanine green angiography (ICG), blue laser autofluorescence, multicolor imaging, and both widefield and ultra-widefield imaging.

“The Flex Module has been an indispensable diagnostic tool for patients who would otherwise be difficult to image, said Lejla Vajzovic, MD, FASRS, principal investigator of the clinical trial for the Spectralis Flex Module. "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 Heidelberg Engineering’s exhibition booth (#4444) during the American Academy of Ophthalmology (AAO) Congress in Chicago from October 19-21, 2024.