Topcon Healthcare, Inc. announced the simultaneous FDA 510(k) clearance—and U.S. commercial launch—of OMNIA, a fully automated pretesting solution for the clinical workflow.
Let’s just dive right into this.
OMNIA consolidates and integrates four key objective tests into a single ophthalmic device:
- Refraction
- Keratometry
- Tonometry
- Pachymetry
Its intent: To deliver fast and reliable measurements that “reduce data collection time, enhance clinical precision, and give (eyecare) practitioners more time to connect with their patients,” according to Topcon President and CEO Ali Tafreshi.
Exactly how fast can this data be captured?
According to an early adopter of the device: OMNI can capture 20 points of data in under 1 minute.
Impressive. Now talk features.
The device offers a one-touch, fully automated user interface and air puff technology (for smoother intraocular pressure measurements)—as well as 360° touch screen rotation to support space optimization and flexible patient positioning and device placement.
As for its integration capabilities: OMNIA is equipped with DICOM compatibility, enabling connectivity to electronic medical records (EMR).
- The device can also send exam data to Topcon’s CV-5000 software and IMAGEnet data management system via a shared folder.
Can I get a visual of this?
Certainly — click here.
So how does OMNIA ensure reliable measurement delivery?
A couple of key features play a role in this:
- Advanced Rotary Prism Technology: Offers an “eccentric rotation of the measurement ring” to reduce any artifact from the fundus
- Super luminescent diode (SLD): A brighter light source that delivers clearer and higher-quality imaging (versus standard light-emitting diode [LED])—ideally improving measurement success rates, including in difficult conditions caused by media opacities
- This is available in both refraction (REF) and keratometry (KRT) measurement modes
And its automated and customized components?
OMNIA’s automatic alignment function is designed to provide accurate readings via a simple button push.
Meanwhile: An optional manual mode enables precise adjustments in complex cases, allowing clinicians to adjust the device’s settings based on their specific testing preferences (with minimal training needed).
Where can I find more specifications on the device?
See here to view OMNIA’s product brochure for details on RFE/KRT measurement ranges.
Lastly: You mentioned OMNIA is also now commercially available?
That’s right! Reach out to Topcon directly to inquire about adding this to your practice.