iHealthScreen seeks FDA 510K clearance for iPredict AMDAMD screening tool
24 May 2023
iPredict AI Eye Screening System is an automated software as a medical device that offers AMDAMD screening, including retinal imaging and rapid reporting of actionable results
iPredict can efficiently and accurately screen AMDAMD in people over 50 years of age. (Credit: Marc Schulte on Unsplash)
Eye care solutions provider iHealthScreen has announced the US Food and Drug Administration (FDA) submission for artificial intelligence (AI)-based iPredict system, designed for early diagnosis of age-related macular degeneration (AMD)AMD).
iPredict AI Eye Screening System is an automated software as a medical device. It offers AMDAMD screening, including retinal imaging and rapid reporting of actionable results.
According to iHealthScreen, primary care and various speciality practices can use the system to screen AMDAMD efficiently and accurately in people over 50 years of age and refer them to an ophthalmologist.
The iPredict AI System screens the high-resolution photographs of the patient’s eyes once they have been uploaded. It then provides the findings of the screening in a fully automated report in less than 60 seconds.
Designed for use in clinics, hospitals, or other healthcare facilities, the iPredict automated report may also suggest a follow-up visit in one year as per the standards of care.
The eye care solutions provider said that the entire process can be completed in five minutes.
iHealthScreen conducted a prospective trial in the general population to evaluate the product’s accuracy, sensitivity, and specificity.
In the study, the iPredict-AMD device showed a sensitivity of 86.86% and a specificity of 94.13%.
iHealthScreen founder and CEO Alauddin Bhuiyan said: “This is a major milestone for iHealthScreen. iPredict eye disease diagnostic tools can help prevent blindness for millions of people and save insurers countless millions of dollars in avoidable healthcare cost.”
In the FDA 510(k) application, the company proposed that iPredict-AMDAMD is indicated for use by healthcare providers to automatically detect early age-related macular degeneration (mteAMD) in adults above 50 years of age who have not been previously diagnosed with Late AMDAMD.
Additionally, it is indicated for use with the DRSPlus colour fundus camera in both primary care and eye care settings, the eye care solutions provider said.
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