Heidelberg Engineering announces FDA clearance for new SPECTRALIS software release

Heidelberg Engineering has received clearance from the US Food and Drug Administration for a new version of its SPECTRALIS imaging software. The update introduces a 250-kHz acquisition speed for optical coherence tomography angiography (OCTA), enhanced TruTrack Active Eye Tracking, and a new Green Autofluorescence Module, with commercial availability planned for the second half of 2026.¹

For clinicians, the clearance expands the acquisition and visualization options on an existing multimodal platform. The update was authorized on the basis of substantial equivalence to legally marketed predicate SPECTRALIS devices, a regulatory standard that addresses safety and equivalence rather than comparative clinical efficacy.²

Regulatory pathway and feature set

The 510(k) pathway is the mechanism FDA uses for modifications to previously cleared devices, and SPECTRALIS modules have repeatedly been cleared through it, including the OCTA Module with SHIFT technology in 2024.¹ The new release raises the maximum OCTA acquisition rate to 250 kHz, complementing the existing 85-kHz and 125-kHz settings, and pairs it with the platform's eye-tracking system to compensate for fixational eye movement during acquisition.¹

The Green Autofluorescence Module uses green-wavelength excitation, reported by trade coverage at 518 nm, to image the macula.¹ Compared with conventional 488-nm blue-light autofluorescence, longer green-wavelength excitation is less absorbed by macular pigment (lutein and zeaxanthin), which can improve visualization of the central macula and of residual foveal tissue—so-called foveal sparing—in macular atrophy.³ The module is designed to work with RegionFinder, Heidelberg's semi-automated atrophy-quantification tool, which has shown high inter- and intra-observer reliability for geographic atrophy (GA) area measurement on autofluorescence imaging.⁴

Clinical context

OCTA is a dye-free, motion-contrast technique that resolves the retinal and choroidal microvasculature and has been in clinical use since FDA clearance of the modality in late 2016.⁵^,⁶ Its principal advantages are noninvasive, depth-resolved imaging; recognized limitations include susceptibility to motion and projection artifacts and the absence of level-1 evidence for many proposed applications.⁵^,⁷ Faster acquisition is a plausible mechanism for reducing motion artifact and improving throughput, but the manufacturer's speed-related claims for this release have not been independently validated in peer-reviewed comparative studies.

The autofluorescence enhancements are most relevant to GA, the atrophic end stage of age-related macular degeneration (AMD). AMD is projected to affect 288 million people worldwide by 2040,⁸ and GA accounts for a substantial share of irreversible central vision loss in older adults. Accurate delineation of atrophy and of foveal-sparing patterns has acquired added importance since the 2023 FDA approvals of the complement inhibitors pegcetacoplan (Syfovre) and avacincaptad pegol (Izervay), which slow anatomic GA progression.⁹^,¹⁰^,¹¹ Autofluorescence-based lesion characterization informs both patient selection and longitudinal monitoring for these therapies.³^,⁴

Interpretation and limitations

The clinical case for imaging in GA is tempered by an unresolved question about the approved therapies themselves: pivotal trials demonstrated reduced lesion growth on anatomic endpoints, but a corresponding functional or visual-acuity benefit has not been clearly established, and FDA did not require one for approval.⁹ Imaging upgrades that refine atrophy measurement therefore support trial-aligned monitoring but do not address that efficacy gap.

Several caveats apply to the clearance itself. It reflects regulatory substantial equivalence, not demonstrated improvement in diagnostic accuracy or patient outcomes; the 250-kHz speed and green-autofluorescence capabilities have not yet been characterized in independent peer-reviewed studies; and the software is not yet commercially available. Whether faster OCTA and green autofluorescence change real-world diagnostic confidence or workflow will depend on post-launch comparative data that do not currently exist.

References

1. FDA clears Heidelberg Engineering's SPECTRALIS software. Review of Optometric Business. June 9, 2026. https://reviewob.com/fda-clears-heidelberg-engineerings-spectralis-software/ — see also: FDA approves updated Spectralis retinal imaging software. Healio. https://www.healio.com/news/optometry/20260609/fda-approves-updated-spectralis-retinal-imaging-software

2. US Food and Drug Administration. 510(k) Premarket Notification Database. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm — prior SPECTRALIS modification clearance (K223557) for pathway context: https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223557.pdf

3. de Carlo TE, Romano A, Waheed NK, Duker JS. A review of optical coherence tomography angiography (OCTA). Int J Retina Vitreous. 2015;1:5. https://pmc.ncbi.nlm.nih.gov/articles/PMC5066513/

4. Reumueller A, Wassermann L, Salas M, et al. Semi-automated quantification of geographic atrophy with blue-light autofluorescence and SD-OCT: region finder versus the advanced RPE tool. Acta Ophthalmol. 2019;97(8):e1057-e1066. https://onlinelibrary.wiley.com/doi/10.1111/aos.14085

5. Kashani AH, Chen CL, Gahm JK, et al. Optical coherence tomography angiography: a comprehensive review of current methods and clinical applications. Prog Retin Eye Res. 2017;60:66-100. https://pure.johnshopkins.edu/en/publications/optical-coherence-tomography-angiography-a-comprehensive-review-o/

6. Javed A, Khanna A, Palmer E, et al. Optical coherence tomography angiography: a review of the current literature. J Int Med Res. 2023;51(7). https://journals.sagepub.com/doi/10.1177/03000605231187933

7. Holz FG, Bindewald-Wittich A, Fleckenstein M, et al. Progression of geographic atrophy and impact of fundus autofluorescence patterns in age-related macular degeneration. Am J Ophthalmol. 2007;143(3):463-472. https://www.sciencedirect.com/science/article/abs/pii/S0002939406013274

8. Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014;2(2):e106-e116. https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(13)70145-1/fulltext

9. Drug approval for the treatment of geographic atrophy: how we got here and where we need to go. Am J Ophthalmol. 2024. https://www.ajo.com/article/S0002-9394(24)00076-X/fulltext

10. GATHER1 (avacincaptad pegol in GA). ClinicalTrials.gov identifier NCT02686658. https://clinicaltrials.gov/study/NCT02686658

11. GATHER2 (avacincaptad pegol in GA). ClinicalTrials.gov identifier NCT04435366. https://clinicaltrials.gov/study/NCT04435366

12. Lindner M, Boker A, Mauschitz MM, et al. Directional kinetics of geographic atrophy progression in AMD with foveal sparing. Ophthalmology. 2015;122(7):1356-1365. https://doi.org/10.1016/j.ophtha.2015.03.027