New FDA Clearance Means You Can Now Capture Ophthalmoscope Images On Your iPhone

In short

Diagnostic device company Welch Allyn, has received FDA 510(k) clearance to market its iExaminer™ iPhone compatible image capture gizmo. 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 PanOptic™ Ophthalmoscope using the iPhone® 4 or 4S.


The PanOptic Ophthalmoscope features patented optical technology that creates a viewing area of the fundus and retinal nerve in an undilated pupil that is 5 times larger than that of a traditional ophthalmoscope and increases magnification by 26 percent to more easily see retinal details. Welch Allyn tells us that the device, available for shipment on February 11, rapidly captures and transmits the retinal images created by the PanOptic for easy, cost-effective eyeground image documentation. By  aligning the optical axis of the PanOptic to the visual axis of the iPhone 4 or 4S camera, high resolution pictures of a patient’s fundus and retinal nerve can be captured. The iExaminer software application, available from the Apple App Store, then allows physicians to save images to a patient file, as well as e-mail and print the images.

Company comments

“The iExaminer allows healthcare providers to easily capture and share 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 digitally capture eye imaging and will also make it easier for providers to share images with their patients, helping to improve patient knowledge and compliance.”

Physician/Inventor Comments

“This is the first affordable device to give almost anyone, anywhere the ability to capture a picture of the back of the eye,” said Dr. Wyche Coleman, inventor of the iExaminer. “I was able to take this very lightweight, portable, inexpensive iExaminer to the summit of Mount Kilimanjaro in sub-Saharan Africa and take a picture of a patient’s fundus. From the top of the mountain, I then transmitted it to a doctor at Johns Hopkins University in the United States where he was able to analyze the image.”

Source: Welch Allyn, Inc.