EMA issues CE mark for DREAM OCT (Intalight)

A single-shot, 130-degree OCTA image captured using DREAM OCT. Image courtesy of Intalight

Ophthalmic technologies company Intalight has announced that its DREAM optical coherence tomography (OCT) platform received a CE Mark within the European Union.¹ The new OCT tool “provides the highest quality OCT images currently on the market,” according to a news release. DREAM is an acronym for deep imaging depth, rapid sweeping speed, extensive scan range, accurate results and multimodal imaging capabilities.

"Intalight is incredibly proud to receive CE mark approval in Europe for our DREAM OCT," Intalight chairman and founder Shawn Peng said in the release. "This achievement allows us to provide ophthalmologists in Europe with state-of-the-art technology that delivers improved results for their patients."

The DREAM device has the capability of covering an ultrawide single scan, delivering a 130-degree optical coherence tomography angiography (OCTA) image. With swept-source 12 mm super-depth scanning, the DREAM OCT is able to image a large portion of the vitreous space, in addition to providing quality imaging of the choroid and retina. The super-depth anterior scanning achieves 16.2 mm (in air), which allows for the complete anterior segment, from the cornea to the anterior section of the vitreous, to be scanned in a single scan.¹ The device’s capabilities for longer wavelength allows for the penetration through opacities in either the lens or vitreous, the release stated.

"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 Intalight CEO and cofounder Bing Li in the release. "DREAM OCT 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."

Intalight noted that more than 160 peer-reviewed papers have utilised findings from DREAM OCT devices thus far.¹ One of the most recent studies, published in Retina, examined the macular sensitivity using microperimetry in patients with proliferate diabetic retinopathy following vitrectomy. The relationship between the sensitivity and foveal microstructures with OCT/OCTA were also assessed. A total of 84 patients (84 eyes) with proliferative diabetic retinopathy indicated for vitrectomy were included in the study, among other inclusion criteria. LogMAR best-corrected visual acuity, macular sensitivity of microperimetry, macular retinal thickness and macular vessel perfusion using OCT/OCTA were all examined at 1 week, 1 month, and 3 months postoperatively.²

“Postoperative mean macular sensitivity was significantly correlated with outer retinal thickness and deep capillary plexus perfusion for patients with proliferative diabetic retinopathy,” the study authors stated. The authors were led by first author Manqiao Wang, MD, PhD, of Tiangin Key Laboratory of Retinal Function and Diseases, the Tiangin Branch of National Clinical Research Center for Ocular Disease, the Eye Institute and School of Optometry, and the Tianjin Medical University Eye Hospital, all in Tianjin, Chian.²

DREAM OCT devices are currently being utilised in retina academic institutions and retina private practices in the US, Europe and Asia, according to Intalight.¹

"This is such exciting news for Intalight that there's no more waiting in Europe, and we look forward to being able to provide this innovative solution in the US," said Intalight Chief Commercial Officer Joe Garibaldi in the release. "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."

References:

1. Intalight receives CE Mark for its progressive DREAM OCT swept source imaging. News release. PR Newswire. May 15, 2025. Accessed May 19, 2025. https://www.prnewswire.com/news-releases/intalight-receives-ce-mark-for-its-progressive-dream-oct-swept-source-imaging-302454390.html

2. Wang M, Shao Y, Gong Y, et al. Association of macular structure with microperimetry sensitivity following vitrectomy for proliferate diabetic retinopathy. Retina. 2024;44(6):982-990. doi:10.1097/IAE.0000000000004063