FDA clears use of Topcon retinal camera with EyeArt AI system for DR detection
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Key takeaways:
- The EyeArt AI system is cleared for use with multiple retinal cameras by different manufacturers.
- System enhancements include an upgraded image quality assessment module and real-time image quality feedback.
Eyenuk received FDA clearance to use the Topcon NW400 retinal camera with its EyeArt AI system for autonomous detection of diabetic retinopathy, according to a press release.
The clearance for the EyeArt v2.2.0 system was supported by positive data from a prospective multicenter clinical trial in which the Topcon NW400 camera demonstrated 94.4% sensitivity and 91.1% specificity for the detection of more than mild diabetic retinopathy (DR) and 96.8% sensitivity and 91.6% specificity for the detection of vision-threatening DR.
The EyeArt AI system was previously cleared for use with Canon CR-2 AF and Canon CR-2 Plus AF cameras.
EyeArt is the first AI system to be cleared by the FDA for use with multiple retinal cameras by different manufacturers, the release said, which expands access for patients to be screened in primary care offices for preventable blindness due to diabetes.
The system has an upgraded image quality assessment module and proprietary real-time image quality feedback solution to improve usability and “achieve the best-in-class gradability without the need for dilation,” according to the release.
“I am excited that we are bringing several patient- and clinic-friendly product updates to the market through this clearance,” Malavika Bhaskaranand, head of regulatory and clinical affairs for Eyenuk, said in the release. “Real-time image quality feedback can significantly improve the clinical workflows associated with diabetic eye exams, and achieving best-in-class gradability implies much better patient experience and saving of clinic staff time that otherwise would have been spent on dilation.”
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