A group of entrepreneurs who wants to make eye exams more accessible in developing countries has raised $2 million for a smartphone attachment that claims to diagnose nearsightedness, farsightedness and astigmatism, according to a Form D filing with the U.S. Securities and Exchange Commission.
EyeNetra’s device, NETRA G, is based on technology developed in the MIT Media Lab and is designed to be a less bulky alternative to the Shack-Hartmann Wavefront sensor. The company was co-founded by David Schafran, Vitor Pamplona and Ramesh Raskar.
This is how the device works. A $2 clip-on eyepiece is placed on top of a cell phone. The user looks through the eye piece and aligns the displayed patterns by clicking buttons. The number of clicks required to bring the patterns into alignment indicates the refractive error, according to the website. Using a cloud-based platform, called Test2Connect, patients can connect to providers and vendors such as eyeglass stores.
The company’s technology addresses what has been an especially vexing problem in developing countries. A 2012 World Health Organization report estimated that 286 million people have vision impairment, with 246 million of them having low vision (as opposed to blindness). One of the two main causes of vision impairment is uncorrected refractive errors. EyeNetra is in the process of being field tested by 29 research teams in 14 countries.
On the other hand the Netra G would be interpreted by the U.S. Food and Drug Administration as a medical device since it is used to diagnose a condition and would have to follow protocols set down for 510(k) clearance protocols. The FDA has recently demonstrated that it intends to crack down on companies with mobile health apps and accessories sold in the U.S. that act as a diagnostic.