Remidio’s Revolutionary AI on a Smartphone for Referable Diabetic Retinopathy (Dr) Receives EU Mdr Class Ii Regulatory Approval

Remidio has received CE mark approval for its Medios AI, to detect Referable DR. This approval closely follows the nod the AI received from Singapore’s Health Sciences Authority (HSA), assuring compliance with the highest standards.

DR is a complication of diabetes that can cause vision loss and even blindness. With an estimated ~537 million adults living with diabetes today, DR is predicted to be a leading cause of blindness globally.

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Dr. Divya Rao, Remidio’s Medical Director & Head of AI, called the approval a ‘key milestone’ as the first step towards transforming global DR screening.

Medios AI is the world’s only Smartphone-based automated algorithm that works offline. The algorithm harnesses deep learning technology deployed on a smartphone-based fundus camera, Remidio NM-FOP, to detect referable DR within 10 seconds.

Dr. Sobha Sivaprasad, Professor and Consultant Ophthalmologist at Moorfields Eye Hospital, London, UK, said, “Given the growing burden of diabetes and the challenge of establishing and maintaining national DR screening programmes, this AI integrated on a lightweight camera can be utilized in any primary care clinic managing diabetes as it requires minimal expertise, leading to greater coverage of DR screening.”

The solution’s portable nature combined with no internet for inferencing ensures unhindered eye care delivered closer to the patient. Such intuitive technology propels physicians to the forefront of closing the care gap for DR, the first point-of-contact for patients.

Dr. Rao added, “The solution enables newer models of screening by non-eye care professionals that are efficient and bring convenience without bulky equipment.”

Remidio’s vision to eradicate preventable blindness has led it to publish research on a device-agnostic application for Medios DR AI. The algorithm can now be used on desktop and smartphone-based fundus cameras. With additional AI solutions under development to screen for retinal and systemic conditions, the scope of Remidio’s NM-FOP is limitless.

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Medios AI is not FDA-approved and not available for sale in the US.

Remidio is an innovative ISO-13485-certified medical technology company that seeks to impact preventable blindness by creating accessible technologies that are smart and simple to use. Remidio’s CE-marked and FDA 510k-registered devices have helped screen and impact more than 10 million patients globally.

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