Theia Imaging’s Loris T2 Handheld OCT Granted FDA Breakthrough Device Designation for Retinopathy of Prematurity

Theia Imaging is excited to announce a major milestone in our mission to bring advanced ophthalmic imaging to all: our next-generation Handheld OCT device – the Loris T2 – has officially been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).

This designation marks a pivotal moment not just for our team at Theia Imaging, but for the millions of pre-term infants born around the world each year who undergo screening for Retinopathy of Prematurity.

What is the Loris T2 Handheld OCT?

Optical Coherence Tomography (OCT) has revolutionized how ophthalmologists diagnose and manage retinal and neurological diseases. However, traditional clinical OCT systems are large, tabletop devices that require a patient to sit completely still and focus on a target.

For neonates in the intensive care unit (NICU), squirming infants, children, and patients with mobility or cognitive challenges, this is simply impossible. Instead, the current standard of care for ROP screening is Binocular Indirect Ophthalmoscopy (BIO) or white light fundus imaging. While standard practice, BIO relies on a manual technique that is subjective and lacks depth resolution. Furthermore, it requires intense light and mechanical scleral depression to view the peripheral retina, a process that induces physiological stress in premature infants and can trigger bradycardia or apnea.

The Loris T2 is a portable, handheld Swept-Source Optical Coherence Tomography (SS-OCT) platform designed to address these limitations. It brings the imaging to the patient—right at the bedside or in the operating room. By scanning at speeds 5x higher than a typical desktop and with invisible infrared light, it is designed to allow clinicians to capture high-resolution, ultra-widefield, 3D cross-sectional images of the retina in seconds, without requiring patient cooperation.

The Significance of FDA Breakthrough Status

The FDA’s Breakthrough Devices Program is highly selective. It is reserved exclusively for novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

Receiving this status for the Loris T2 highlights a critical recognition by the FDA: there is an urgent, unmet need for advanced diagnostic imaging for the management of Retinopathy of Prematurity (ROP). By granting Breakthrough Device Designation, the FDA provides Theia Imaging with priority review and interactive, expedited communication with FDA experts throughout the premarket review phase.

In short, it means a faster path to clearance so that we can get this life-changing technology into the hands of pediatric ophthalmologists and neonatologists sooner.

Looking Ahead

At Theia Imaging, we believe that every patient—no matter their age, size, or physical ability—deserves access to the highest standard of care. We are incredibly proud of our engineering and clinical teams for developing a solution that bridges this critical gap in ophthalmic care.

The FDA Breakthrough Designation for the Loris T2 is a validation of our vision and a powerful catalyst for our next steps. We look forward to working closely with the FDA to bring the Loris T2 to market and, ultimately, to the bedsides of the patients who need it most.

We are looking forward to conducting our clinical study this year. This study will be a critical step in further validating the clinical utility of the Loris T2 in ROP management and supporting our regulatory submissions.

To learn more about our technology and our mission to make advanced ophthalmic diagnostics accessible to everyone, explore our website or contact us today.