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FDA Clears Canon's Tomography System to Aid in Diagnosis of Retinal Diseases


The device is designed to help providers capture high-res images and scans of eyes.


Canon U.S. today announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its Xephilio OCT-A1 Optical Coherence Tomography to aid clinicians in the diagnosis and management of retinal diseases.

The device allows healthcare providers to obtain high-quality reproducible scans and images. The system is used for the in-vivo imaging and measurement of the retina, retinal nerve fiber layer and optic disc.

“Designed to meet the needs of customers, the Xephilio OCT-A1 System is a user-friendly solution designed to help healthcare professionals capture high-resolution images and scans with ease and efficiency,” said Tsuneo Imai, vice president and general manager of healthcare solutions at Canon U.S.

The system has a scanning speed of 70,000 A-scans per second with optical depth resolution of approximately three microns, according to Canon.

Xephilio OCT A-1 has integrated scanning laser ophthalmoscopic real-time retinal tracking technology and automatically retains the scan positions and protocol for each patient from one exam to the next.

Providers can use the system in a variety of settings, including private practices, optometric schools and for telehealth services. Healthcare professionals can also use the system to identify the disease state and monitor conditions before and after treatments from multiple locations, the company said.

Optometry students can use the system to recognize diseases and conditions in primary care and to detect conditions prior to and after referral to ophthalmology practitioners.

“(Xephilio OCT A-1) is the type of system that may assist students preparing to enter the competitive field of eye care,” said Ben Szirth, Ph.D., director of the tele-ocular program at the Institute of Ophthalmology and Visual Science at the New Jersey Medical School.

The FDA, along with other health-tech power houses, see potential in using devices for retina-related conditions and even concussions.

Earlier this year, the FDA granted approval for EyeBOX, an eye tracking device to aid in the diagnosis of concussions.

And last year, Google acquired Eyefluence and employed eye experts to sharpen its disease-detecting artificial intelligence.

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