Welch Allyn lands FDA nod for iExaminer iPhone eye exam

Welch Allyn's iExaminer

Healthcare products maker Welch Allyn won FDA clearance for its iExaminer, a snap-on adapter that pairs the company’s PanOptic ophthalmoscope with the iPhone 4 and 4S to capture high-resolution images of the back of the eye and the optical nerve.

The iExaminer lines up the PanOptic’s lens with the iPhone camera, allowing clinicians to use the phone and a paired app to capture and share opthalmic images on the go.

With 510(k) clearance now in hand Welch Allyn expects to begin shipping the iExaminer on February 11, according to a press release.

The device holds particular promise for remote healthcare providers, allowing "almost anyone, anywhere" to capture a picture of the back of the eye than can then be sent to eye care specialists, as well as to the patient and patient’s family.

"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," iExaminer inventor Dr. Wyche Coleman said in prepared remarks. "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."

The free version of the related iPhone app allows clinicians to capture and store up to 10 patient files, with a paid upgrade available for retaining more records.

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