Remidio Medios DR AI Becomes India’s First Approved Ophthalmic AI Software

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Remidio Medios DR AI, a groundbreaking offline AI solution launched in 2018, has achieved a significant milestone with its approval by the Central Drugs Standard Control Organization (CDSCO) in India. This innovative technology, designed to detect referable diabetic retinopathy (DR) without internet connectivity, is integrated with Remidio’s portable retinal cameras. The CDSCO approval follows previous approvals from the European Union and Singapore, demonstrating the technology’s global recognition.

Remidio, a leading healthcare technology company with a presence in India, the United States, and Singapore, has been at the forefront of leveraging AI for accessible healthcare. Their Medios DR AI has been successfully deployed in remote regions of India, from the mountainous areas of Himachal Pradesh to the rural landscapes of West Bengal. This technology has brought essential eye care services to communities that were previously underserved.

Sundeep Agarwal, Remidio’s Senior VP of Regulatory Affairs & Quality Assurance, emphasized the importance of this approval in India’s regulatory landscape, particularly as AI and software are now subject to risk-based frameworks. He highlighted Remidio’s commitment to rigorous research and compliance with international standards, which contributed to their technology’s approval.

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As reported by indiamedtoday.com, to validate the performance of their AI algorithms, Remidio conducted extensive clinical trials in partnership with renowned eye care institutions across India. These trials were published in prestigious journals, including JAMA Ophthalmology, Nature Eye, and the Indian Journal of Ophthalmology. The solution’s effectiveness has also been recognized internationally, with successful deployments in Poland, Armenia, the Yucatán Peninsula, Africa, and the UK.

The offline nature of Remidio Medios DR AI eliminates the need for expensive cloud infrastructure, making it a cost-effective solution for providing equitable healthcare, especially in regions with limited digital resources.