FDA Clears Enhanced SPECTRALIS® OCTA Module by Heidelberg

Heidelberg Engineering announced the FDA clearance of its upgraded SPECTRALIS® OCTA Module featuring SHIFT technology. This advancement promises to significantly reduce acquisition time by 50%, marking a pivotal development in clinical efficiency and diagnostic precision within ophthalmology.

Enhancing Clinical Utility and Image Quality

The SPECTRALIS OCTA Module, renowned for its superior resolution and cost-effectiveness compared to traditional angiography, has historically faced adoption challenges due to prolonged acquisition times. Ram Liebenthal, General Manager USA at Heidelberg Engineering, underscored the transformative impact of the new technology: "We are thrilled to introduce the next generation of OCTA that increases the acquisition speed without sacrificing image quality, thus making it a more versatile clinical tool in the diagnoses and management of retinal diseases."

Empowering Practitioners with Enhanced Speed and Precision

The SHIFT technology integrates a more potent OCT engine, enhanced graphics processing capabilities, and software optimizations, ensuring accelerated speed while preserving data integrity and overall system performance. Exclusively available on third-generation SPECTRALIS devices, this advancement combines an 85 kHz preset for structural OCT and a rapid 125 kHz preset for OCT angiography (OCTA), empowering eye care practitioners to conduct patient exams more efficiently.

Notably, the 125 kHz OCTA preset enables practitioners to visualize blood flow within even the minutest vessels while minimizing artifacts, thereby producing sharp and detailed images of the capillary network. Dennis M. Marcus, MD, principal investigator of the clinical trial, emphasized the significance of reduced scanning time: "Reducing the scanning time for OCTA without diminishing the resolution is a huge step forward, not only for SPECTRALIS but for the industry. Speed plus image quality eliminates the barriers and opens the door for mainstream adoption. I think we will start to see more doctors warm to the idea of trying OCTA as part of the routine clinical work-up for at-risk patients."

Streamlined Workflow and Superior Image Quality

Heidelberg Engineering's latest innovation promises to streamline workflow, enhance clinical efficiencies, and uphold superior image quality, marking a milestone in the integration of OCTA technology into routine ophthalmic practice. With FDA clearance secured, the SPECTRALIS OCTA Module with SHIFT technology is poised to redefine standards in retinal imaging and disease management across the healthcare landscape.