FDA clears non-mydriatic fundus camera

Fremont, CA, and Jacksonville, FL-Nidek has received FDA 510(k) clearance for a non-mydriatic automated fundus camera (AFC-330) that it will market to the U.S. ophthalmology market and Marco Ophthalmic will market to the optometry market.

The model features a new operator/patient interface designed to increase simplicity, automation, and practice efficiencies, according to Nidek. The device offers an all-in-one compact design, auto alignment on the X-Y-Z axis, and a range of automated features, including auto stereo for glaucoma management. The lower flash intensity and sound-dampening internal movements are meant to result in fewer retakes and improved patient comfort.

The device is Nidek’s third generation of automated fundus camera, said Motoki Ozawa, president and chief executive officer (CEO) of Nidek, adding: “We anticipate increasing our fundus camera market share with our market expansion with Marco Ophthalmic.”

The new arrangement with Marco Ophthalmic has a goal of increasing distribution channels and better serving new and existing customers, according to the companies.

“We couldn’t be more excited about adding the . . . camera to our full product line of diagnostic technologies,” said David Marco, president and CEO of Marco Ophthalmic.

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