FDA clears SPECTRALIS Flex module for advanced ophthalmic imaging
The FDA has cleared the SPECTRALIS Flex Module (Heidelberg Engineering), an innovative diagnostic platform designed to enhance access to multimodal imaging for patients unable to use traditional tabletop OCT devices, according to a press release.
The Flex Module features a movable stand with an adjustable arm, allowing clinicians to image both pediatric and adult patients in a supine position. This flexibility is critical for individuals with limited mobility, providing access to high-quality imaging that is often unavailable in conventional settings.
“The Flex Module aligns with our goal of ensuring all patients, regardless of age or physical condition, benefit from Heidelberg’s imaging technology,” said Ram Liebenthal, General Manager US at Heidelberg Engineering.
The device offers a wide range of imaging modalities, including OCT, OCT Angiography, Fluorescein and Indocyanine Green Angiography, and ultra-widefield imaging. Dr. Lejla Vajzovic, a clinical trial investigator, emphasized that the Flex Module’s high-resolution imaging aids in diagnosing macular and optic nerve conditions for patients in challenging positions, enabling timely, life-changing treatment.
This clearance is expected to expand diagnostic access, particularly for underserved patients, advancing ophthalmic care delivery.