Topcon Healthcare’s OMNIA Gets FDA 510(k) Clearance, Hits U.S. Market

FDA-approved and U.S.-bound: OMNIA is hitting the market as an all-in-one pretesting solution.

Topcon Healthcare (Tokyo, Japan) has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for OMNIA, a fully automated pretesting system that combines objective refraction, keratometry, tonometry and pachymetry into a single device. Alongside the regulatory approval, the company has announced the U.S. commercial launch of the system.

OMNIA is designed to address the workflow headaches clinicians face today. It aims to streamline the earliest phase of the patient journey, improve reproducibility of measurements, and support clinics operating in high-volume or multisite environments.

“Healthcare from the Eye starts with consistent, high-quality data,” said Topcon CEO and President Ali Tafreshi in a news release. “OMNIA delivers fast, reliable measurements that reduce data collection time, enhance clinical precision and give practitioners more time to connect with their patients.”

Designed for workflow efficiency

OMNIA’s standout feature is the consolidation of multiple pretest instruments into one compact device. This reduces room footprint and eliminates the need for patients to move between separate testing rooms. A 360-degree rotating monitor allows technicians to adjust placement based on room limitations or patient mobility, supporting flexible clinic layouts.

The system, which is DICOM-compatible, enables integration with electronic medical records and digital imaging platforms—an increasingly essential feature as ophthalmology moves toward interconnected diagnostic workflows. For practices relying on a multi-level data review or cross-site record sharing, compatibility with established digital systems helps ensure continuity of patient information.

Measurement and reliability

Several engineering features are built into the platform to minimize variability and improve measurement consistency:

Advanced Rotary Prism Technology to reduce artifacts from fundus reflections.
Super luminescent diode (SLD) illumination, offering stronger signal quality compared to standard LED sources and reliable data even with early media opacity.
Low-noise operation, enhancing patient comfort during pretests.

Lance Patton, Topcon’s chief commercial officer said, “OMNIA gives practices exactly what they’ve been asking for—fast, consistent measurements that streamline the entire pretest workflow.” He added, “By combining four critical tests in one device, we’re helping clinics reduce bottlenecks, shorten chair time and elevate the patient experience.”

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Training and customization

OMNIA features an automatic alignment for one-touch capture, lowering the operational learning curve and allowing users to acquire standardized data with minimal training. A manual mode is available for complex cases, such as irregular corneas fixation.

Clinics can also customize which tests are performed during each session, letting the device adapt to different patient types and visit purposes. This allows MD/OD teams to maintain their preferred clinical pathways without reconfiguring multiple instruments.

“We trained our entire staff on OMNIA within the first hour of installation,” said Dr. Brittany McMurren of Werner Optometry (California, USA). “Our team loves its efficiency and reliability, and our patients are impressed when we explain that the device captures 20 points of data in under a minute.”

Conclusion

With FDA clearance in hand, OMNIA now enters the U.S. market as a compact, automated option for clinics seeking reliable, standardized measurements.

Editor’s Note: This content is intended exclusively for healthcare professionals. It is not intended for the general public. Products or therapies discussed may not be registered or approved in all jurisdictions, including Singapore.