FDA grants 510(k) clearance to AI Optics’ handheld retinal imaging system
Key takeaways:
- AI Optics developed the Sentinel Camera to help address barriers to retinal disease screening.
- The device is designed to be easy to use and portable.
The FDA has granted 510(k) clearance to AI Optics’ Sentinel Camera, a handheld retinal imaging system that captures high-quality images without the need for dilation, according to a press release.
The portable device was developed to address “critical gaps in retinal disease screening” and “to meet the needs of general health care providers,” the release stated.
“Our vision with the Sentinel Camera is to eliminate barriers to retinal screening and ensure that every patient who needs screening has access,” Luke Moretti, AI Optics’ co-founder and CEO, said in the release. “This FDA clearance not only validates our significant progress to breaking down screening barriers but also sets the stage for our future AI-powered screening solutions, which will integrate seamlessly with the Sentinel Camera to deliver unparalleled accessibility and efficiency in retinal disease detection.”
According to the manufacturer, the Sentinel Camera supports Digital Imaging and Communications in Medicine-compliant image formats, which allows for integration with electronic health record systems.
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