Heidelberg Engineering has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the Spectralis optical coherence tomography angiography (OCTA) module with SHIFT technology. According to a company press release, this new technology reduces image acquisition time by 50%.
The 85 kHz preset for structural OCT and the 125 kHz preset for OCT angiography (OCTA) enable eye-care practitioners to complete patient exams more efficiently. The 125 kHz OCTA image acquisition rate allows for the visualization of flow, even in minuscule vessels, while minimizing artifacts, resulting in sharp and detailed images of the capillary network.
Heidelberg’s SHIFT technology, combined with a more powerful OCT engine, updated graphics processing technology, and software optimization, delivers increased speed, maintains data integrity, and improves performance. This technology is exclusively available on third-generation SPECTRALIS devices.
“Reducing the scanning time for OCTA without diminishing the resolution is a huge step forward,” said Dennis M. Marcus, MD, principal investigator of a clinical trial (NCT04604002) completed earlier this year that evaluated the new OCTA module. “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.”