Luminopia’s new-old FDA authorization  Luminopia in 2021 received FDA clearance for its for childhood lazy eye treatment that's delivered through a virtual reality headset. This fall it received an FDA clearance for… exactly the same thing. So what’s the difference? The clinical study supporting the company’s original clearance was done on a Samsung headset, but as the company moved to launch the product to patients, it settled on a Pico headset that’s commonly used for commercial purposes. The new submission, excerpted above, demonstrates that the hardware specifications relevant to the treatment are the same between the devices. Founder and CEO Scott Xiao told me this week that the company has established a reliable framework with FDA for how it will validate new headsets. “That's a really important piece for us because it gives us some flexibility to be able to qualify new headset models as they're released,” he said. “As we think about the future, if patients have their own VR headset, we want to be able to support them downloading the software.” As more companies seek clearances for products that run on commercial hardware, this will no doubt come up more and more. Luminopia in November announced it had raised $5.7 million in additional funding and over the last month, has been conducting a limited rollout of the product with pediatric ophthalmologists to make sure all of the prescribing logistics work. He said the company has a waitlist of about 200 doctors who want to offer the treatment. |
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