Ophthalmic imaging product receives 510(k) clearance

Skaneateles Falls, NY-Welch Allyn has received 510(k) clearance from the FDA for the iExaminerT. The product consists of a hardware adapter and associated software that allows healthcare providers to capture, store, send, and retrieve images from the Welch Allyn PanOpticT Ophthalmoscope using the iPhone 4 or 4S.

“The iExaminer allows healthcare providers to capture and share [easily] the images of a fundus in a moment's notice, helping to improve the quality of care provided-especially for remote users who may not have easy access to specialists,” said Rick Farchione, senior manager, physical assessment at Welch Allyn. “It will increase workflow efficiency by allowing providers to capture and share images from any clinical environment. It is a low-cost way to capture eye imaging [digitally] and will also make it easier for providers to share images with their patients, helping to improve patient knowledge and compliance.”

The iExaminer adapter aligns the optical access of the PanOptic to the visual axis of the iPhone 4 or 4S camera to capture high-resolution pictures of a patient’s fundus and retinal nerve. The iExaminer software application then allows physicians to save images to a patient file, as well as e-mail and print the images.

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