Heidelberg Engineering’s SPECTRALIS OCTA Module With SHIFT Technology Wins FDA Clearance

The U.S. Food and Drug Administration has cleared Heidelberg Engineering’s SPECTRALIS OCTA Module with SHIFT technology, which cuts acquisition time in half.¹ 
 
“While SPECTRALIS OCTA Module has always been a safe and cost-effective precursor to traditional angiography, delivering unparalleled resolution, many eye care practitioners have hesitated to fully adopt this advanced technology into daily clinical practice because of the acquisition time,” Heidelberg Engineering U.S. General Manager Ram Liebenthal said. “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.”
 
Combined with a more powerful OCT engine, updated graphics processing technology, and software optimization, SHIFT technology delivers increased speed, maintains data integrity, and improves performance. The preset OCTA speed of 125 kHz is designed to help streamline workflow, enhance clinical efficiencies, and maintain Heidelberg image quality.

The SHIFT technology is available exclusively on third generation SPECTRALIS devices. 
 
Both the 85 kHz preset for structural OCT and the 125 kHz preset for OCT angiography (OCTA) allow eye care practitioners to complete their patient exams more efficiently. Furthermore, the 125 kHz OCTA image acquisition rate allows for visualization of flow, even in miniscule vessels, while minimizing artifacts, resulting in sharp and detailed images of the capillary network.
 
“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,” stated Dennis M. Marcus, M.D., principal investigator of the clinical trial. “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.”
 
Heidelberg Engineering continuously optimizes imaging and healthcare IT technologies to provide ophthalmic diagnostic solutions that empower clinicians to improve patient care. From its inception in 1990, the company has collaborated with scientists, clinicians, and industry to develop innovative products that deliver clinically relevant benefits. The company’s expertise in developing and implementing intelligent image and data management solutions complements its history in designing, manufacturing, and distributing ophthalmic diagnostic instruments. Heidelberg Engineering’s product portfolio combines the following core technologies: confocal microscopy, scanning lasers and optics, optical coherence tomography (OCT), real-time image processing and analytics, multimodal image management solutions (PACS), electronic medical records (EMR), and large-scale data analysis.

Reference
¹ Heidelberg Engineering Acquisition Time Comparison Video: SPECTRALIS with OCT2 Module at 85 kHz vs. SPECTRALIS with SHIFT Module at 125 kHz.