Topcon Healthcare, Inc. Receives 510(k) Clearance and Announces Launch of OMNIA – a 4-in-1 Automated Pretesting Solution
TRK-3 Auto Kerato-Refracto Tonometer – OMNIA System Integrates Objective Refraction, Keratometry, Tonometry, and Pachymetry into a Single Compact Device
LA JOLLA, CA — Topcon Healthcare, Inc., a global leader in ophthalmic medical devices and digital health solutions, today announced the U.S. FDA 510(k) clearance and commercial launch of OMNIA, a fully automated 4-in-1 pretesting solution that seamlessly integrates objective refraction, keratometry, tonometry, and pachymetry into a single compact device. Designed to enhance efficiency across diverse practice settings, OMNIA enhances workflow, shortens training time, and provides reliable data even when operated by new users.
“Healthcare from the Eye™ starts with consistent, high-quality data,” said Ali Tafreshi, CEO & President of Topcon Healthcare, Inc. “OMNIA delivers fast, reliable measurements that reduce data collection time, enhance clinical precision, and give practitioners more time to connect with their patients.”
Workflow and Space Optimization
By consolidating objective refraction, keratometry, tonometry, and pachymetry into a single compact unit, the OMNIA saves space and improves the speed and efficiency of the pretest workflow. The 360-degree rotating screen also supports space optimization and efficiency by enabling flexibility in patient positioning and device placement. DICOM compatibility allows for seamless integration into digital workflows for efficient data sharing with electronic medical records.
“OMNIA gives practices exactly what they’ve been asking for — fast, consistent measurements that streamline the entire pretest workflow,” said Lance Patton, Chief Commercial Officer, Topcon Healthcare, Inc. “By combining four critical tests in one device, we’re helping clinics reduce bottlenecks, shorten chair time, and elevate the patient experience.”
Reliable Measurements
OMNIA combines several unique features to ensure reliable measurements and patient comfort. Topcon’s Advanced Rotary Prism Technology is designed to reduce artifact from the fundus. The super luminescent diode (SLD) delivers brighter, higher-quality imaging than LED, ensuring reliable measurements even in challenging conditions caused by media opacities such as cataracts. The device’s quiet and softer air puff enhances patient comfort.
Easy Customization and Training
The OMNIA’s automatic alignment function ensures accurate readings at the push of a button, while the optional manual mode allows for precise adjustments in complex cases. Practitioners can program device settings for their specific preferences, selecting the tests — (objective refraction, keratometry, tonometry, or pachymetry) that support their clinical approach. With its fully automated, one-touch interface, the device ensures reliable data capture with minimal training.
“We trained our entire staff on OMNIA within the first hour of installation,” said Brittany McMurren, OD, Werner Optometry (El Cajon, CA). “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.”
About Topcon Healthcare, Inc.
Topcon Healthcare, Inc. is part of Topcon Corporation, a leading provider of digital healthcare solutions. Our vision is to improve access and quality of healthcare while decreasing the cost of care. To achieve this vision, we created Healthcare from the Eye™, a connected care ecosystem using AI-powered disease detection and management applied to noninvasive retinal imaging. For more information, visit topconhealthcare.com.
MEDIA CONTACT
Topcon Healthcare
Leslie Amodei
VP, Marketing for Americas
[email protected]
www.topconhealthcare.com
