Heidelberg Engineering Gmb has received FDA clearance for the latest release of its SPECTRALIS software, designed for multimodal retinal imaging.
First and foremost: What clearance is this?
This would be FDA 510(k) clearance, as this pathway is utilized for modifications to existing devices (such as the SPECTRALIS).
- See here for its updated clearance confirmation in the FDA’s database.
Noted. Now, tell me more about SPECTRALIS.
What it is: A non-contact ophthalmic diagnostic imaging platform featuring an upgradable (hence this latest clearance) modular design that combines scanning laser fundus imaging with high-resolution optical coherence tomography (OCT).
Among its multimodal imaging options:
- OCT
- OCT-angiography (OCTA)
- Multiple scanning laser fundus imaging modalities
- Widefield and ultra-widefield
- Scanning laser angiography
These options are accessible via 10 SPECTRALIS modules (among them: glaucoma, multicolor, anterior segment, and widefield imaging).
And didn’t the platform already receive an expanded clearance?
Indeed—multiple times over, including in both July and October 2024.
But those were for two new module options (the OCTA Module with SHIFT technology and Flex Module, respectively).
Gotcha. Well then, let’s hear about this new addition.
The platform’s newest release relates to that aforementioned OCTA Module with SHIFT technology.
To refresh: This technology offers changeable OCT scan speeds (20 kHz, 85 kHz, and 125 kHz) to attain an optimal balance between image quality and workflow, enabling clinicians to adapt and have greater flexibility in offering precise and individualized patient care.
- When combined with OCTA: the preset scan speed is 125 kHz.
- Check out the advantages that come with this
And how does the update build on those capabilities?
“Designed to deliver speed, workflow flexibility, and diagnostic depth” to multimodal retinal imaging, this latest release increases that maximum scan speed to 250 kHz—the platform’s fastest OCTA image acquisition yet.
Notably: This increase is also supported by TruTrack Active Eye Tracking, a patented, real-time eye motion-compensation technology built into the SPECTRALIS platform.
- What it does: Effectively “freezes” the retina to allow a precise OCT image to be captured (even if a patient blinks or moves) via a second laser beam that actively tracks the fundus during OCT scanning.
Any other updates to be aware of?
Heidelberg also made mention of an expanded scope for the platform’s Green Autofluorescence (AF) Module, designed to improve visualization of the macula and enable identification of key features in retinal and optic nerve health.
What it does: Utilizes 518 nm excitation light to:
- Improve visualization of foveal sparing in macular atrophy
- Support the assessment of ipofuscin distribution and retinol pigment epithelium (RPE) loss
- These are critical in managing geographic atrophy (GA) and Stargardt disease
And can that module be combined with another technology?
Indeed. Specifically, another module: BluePeak.
This module encompasses a non-invasive scanning laser fundus imaging modality that presents a map of the retina—using lipofuscin as an indicator.
This reveals metabolic malfunctions for diagnostic purposes in retinal diseases such as age-related macular degeneration (AMD).
When combined with the Green AF module, the BluePeak blue AF imaging is reported to offer a “comprehensive view of retinal structure and metabolic changes.”
… are those all the new additions?
There are a few more … click here for a deeper dive into what’s new, including:
- A low-luminance AF feature
- An updated change analysis function for the posterior pole scan (in the platform’s Glaucoma Module)
- Custom scan presets for users
And now to the big question: When will the new software release be available?
Heidelberg is currently planning for an H2 2026 commercial launch—so stay tuned!
And for any questions in the meantime, contact the company directly.