Most medical device companies go after approvals for pediatric devices only after an adult version of the technology has been given the greenlight. Welch Allyn is going about the process a little bit differently when it comes to the Spot Vision Screener, a device that tests a person’s vision.
“Spot Vision Screener was originally purposed for that pediatric population,” Chuck Witkowski VP and General Manager, Vision Care, for Welch Allyn, told MD+DI. “I would just really credit our customers, key opinion leaders, and clinical consultants for helping us understand the needs of the adult population and really encouraging us to extend our indications to serve that population as well.”
The Skaneateles, NY-based company said the new enhancements to the Spot Vision Screener enable the device to quickly and effectively screen for vision issues in adult patients with pupil sizes as small as 3 mm.
“As we age, and our bodies change, our pupils tend to get smaller and it makes it much more difficult to acquire the readings and data,” Witkowski said. “The major breakthrough from a technology standpoint was enabling our spot vision screener to take accurate readings of pupils as small 3mm, which allows it to then be used on an adult patient population.”
The device screens both eyes at once from a three-foot distance. The touch-screen display allows for one-touch activation, simple management of patient data entry, and easy configuration for both vision screening and autorefraction applications, which are performed simultaneously. There are some estimated 15,000 Spot Vision Screener devices currently in use worldwide.
Witkowski said the previous machines can scan for adults with a software upgrade.
The Spot Vision Screener is a Class I device and doesn’t require premarket approval. But the company did have to undergo significant internal testing and validation verification to demonstrate and document that it met the requirements to market the device as a baseline autorefractor.
The software update, was announced at the Japanese Ophthalmological Society Conference in Osaka, Japan.