Intalight's DREAM OCT Platform Receives CE Mark Approval for European Market
核心洞察
Intalight (搜索) has received CE Mark approval for its DREAM OCT (搜索) platform, allowing commercialization in the European Union with advanced imaging capabilities that deliver 130-degree OCTA images.
The DREAM OCT (搜索) features swept-source 12mm super-depth scanning that images the choroid, retina, and vitreous space, with anterior scanning reaching 16.2mm to capture the complete anterior segment in a single scan.
Over 160 peer-reviewed papers have utilized findings from DREAM OCT (搜索) devices, with the technology currently being used in retina academic institutions and private practices across the US, Europe, and Asia.
Ophthalmic technologies company Intalight (搜索) announced that its DREAM optical coherence tomography (搜索) (OCT) platform has received CE Mark approval within the European Union, allowing for commercial distribution across Europe. The platform, which stands for Deep imaging depth, Rapid sweeping speed, Extensive scan range, Accurate results, and Multimodal imaging capabilities, is claimed to provide "the highest quality OCT images currently on the market."
"Intalight (搜索) is incredibly proud to receive CE mark approval in Europe for our DREAM OCT (搜索)," said Shawn Peng, Intalight's chairman and founder. "This achievement allows us to provide ophthalmologists in Europe with state-of-the-art technology that delivers improved results for their patients."
Advanced Imaging Capabilities
The DREAM OCT (搜索) platform features several technological advancements that distinguish it from conventional OCT devices. It can cover an ultrawide field single scan, delivering a 130-degree optical coherence tomography (搜索) angiography (OCTA) image. The swept-source 12mm super-depth scanning capability allows for superior imaging of the choroid and retina, while also capturing a large portion of the vitreous space.
For anterior segment imaging, the device achieves 16.2mm scanning depth (in air), enabling complete visualization from the cornea to the anterior part of the vitreous in a single scan. Additionally, the longer wavelength technology allows for superior penetration through opacities in either the lens or vitreous, addressing a common challenge in ophthalmic imaging.
"Over the past few years, we've heard from eye care professionals that they need a solution that gets them over the imaging finish line with speed, accuracy and depth," said Bing Li, Intalight (搜索) CEO and co-founder. "DREAM OCT (搜索) delivers a full set of imaging modalities for the most challenging clinical and research applications for the retina and outperforms everything else health care providers know."
Clinical Research Applications
The technology has already made significant contributions to ophthalmic research, with more than 160 peer-reviewed papers utilizing findings from DREAM OCT (搜索) devices. One recent study published in Retina examined macular sensitivity using microperimetry in patients with proliferative diabetic retinopathy (搜索) following vitrectomy.
The study, led by Dr. Manqiao Wang of Tianjin Medical University Eye Hospital, included 84 patients with proliferative diabetic retinopathy (搜索) indicated for vitrectomy. Researchers assessed the relationship between sensitivity and foveal microstructures with OCT/OCTA. The study found that "postoperative mean macular sensitivity was significantly correlated with outer retinal thickness and deep capillary plexus perfusion for patients with proliferative diabetic retinopathy."
Global Expansion Plans
DREAM OCT (搜索) devices are currently being utilized in retina academic institutions and private practices across the US, Europe, and Asia, according to Intalight (搜索). With the CE Mark approval secured, the company is now focusing on expanding its European presence while working toward FDA approval in the United States.
"This is such exciting news for Intalight (搜索) that there's no more waiting in Europe, and we look forward to being able to provide this innovative solution in the US," said Joe Garibaldi, Intalight's Chief Commercial Officer. "We look forward to continuing to grow our prestigious network of global institutions and ophthalmologists with our recent CE approval and eventually our FDA approval."
The CE Mark serves as a significant regulatory milestone for Intalight (搜索), confirming that the DREAM OCT (搜索) platform meets the health, safety, and environmental protection requirements for products sold within the European Economic Area.