OCTA is a key component of the SPECTRALIS portfolio, delivering on the platform’s upgradeability and multimodal image capabilities.
Franklin, MA – September 17, 2018 – Heidelberg Engineering, a privately-held imaging solutions company focused on advanced diagnostic instruments and IT solutions for eye care professionals, announced today that it has received US Food and Drug Administration (FDA) clearance for its OCT Angiography Module (OCTA). The additional module is now available for new and existing SPECTRALIS® upgradeable diagnostic imaging devices.
“We are excited to announce this FDA clearance as further validation not only of OCTA technology in the industry, but also of our commitment to meeting the highest expectations of our customers,” said Ram Liebenthal, General Manager of Heidelberg Engineering, Inc.
“Our international experience with the SPECTRALIS OCTA Module has confirmed the significance of our live eye tracking and dynamic angiography to acquire clinically relevant data. It also demonstrates our continued dedication to delivering high-resolution images, powerful clinical tools, and a multimodal diagnostic approach to aid eye care professionals in the detection and management of diverse eye conditions, all on a single platform.”
OCTA is a noninvasive imaging technique that provides three-dimensional visualization of perfused ocular vasculature. Combined with structural OCT and dye-based angiography, the OCTA technology is designed to give clinicians a more comprehensive understanding of ocular abnormalities.
“Since the original 510(k) clearance of OCT angiography, there have been significant advancements in the technology and specifically in its clinical applicability, making the validation of the technology a much more rigorous task,” said Ali Tafreshi, Head of Product Management and Clinical Affairs. “For this reason, it was vital to collaborate with respected experts who could clinically validate our OCTA Module to receive 510(k) clearance.”
“The addition of OCT angiography to Heidelberg’s SPECTRALIS multimodal platform allows for the evaluation of retinal and choroidal vascular abnormalities in a noninvasive manner,” said Nadia K. Waheed, MD, MPH, Director of the Boston Image Reading Center and Associate Professor of Ophthalmology, Tufts University School of Medicine, Boston. “I believe OCTA will soon become invaluable in our daily clinical routine for screening and diagnosing chorioretinal disorders.”
“OCTA is an amazing addition to Heidelberg’s already best-in-class OCT retina imaging technology we use in our 12 Houston area clinics to manage diabetic retinopathy, age-related macular degeneration, and other macular diseases,” said David M. Brown, MD.
Dr. Brown is the Director of the Greater Houston Retina Research Center and a retina specialist at Retina Consultants of Houston. Retina Consultants of Houston served as a clinical trial site for this FDA clearance and Dr. Brown served as the principal investigator (PI).
“With the introduction of new technology such as OCTA, we recognize there is a great need for continual learning,” said Mr. Liebenthal. “For this reason, we are fully committed to providing best-in-class training and education through the Heidelberg Engineering Academy to ensure clinicians are empowered to confidently use the technology in daily practice.”