CDSCO approves country’s first ophthalmic AI software Remidio Medios DR AI 

Remidio Medios DR AI, launched in 2018, is an offline AI that detects referable DR without requiring Internet access

Bengaluru-based Remidio, with offices in India, US and Singapore, received CDSCO approval for its Medios DR AI. It is used with its portable retinal cameras. This approval comes after the same solution received CE marking under EU-MDR guidelines and HSA approval in Singapore in 2022.

Remidio Medios DR AI, launched in 2018, is an offline AI that detects referable DR without requiring Internet access. It is currently being used in some of India's most remote areas, from the hilltops of Himachal Pradesh to rural West Bengal, bringing essential eye care to communities that previously had limited access.

Sundeep Agarwal, Remidio's Senior VP of Regulatory Affairs & Quality Assurance, said, "With AI and software now under a risk-based framework in Indian MDR, this is a key milestone in the country's regulatory landscape. While the approval process was challenging, Remidio's focus on assessing public health risks through collaborative research, in addition to compliance with GDPR, HIPAA, cybersecurity, and ISMS standards, positioned our technology as future-ready to the regulators."

More than nine independent prospective clinical trials were completed on Remidio's AI algorithms between 2017 and 2024, in partnership with Aravind Eye Care System, Dr Mohan's Diabetes Specialties Clinic, LV Prasad Eye Institute, DIACON, Retina Institute of Karnataka, Aditya Jyot Eye Hospital, Narayana Nethralaya, and the Government of Kerala, to name a few of the eye care and primary care partners across India.

These trials were published in renowned peer-reviewed, high-impact journals such as JAMA Ophthalmology, Nature Eye, and the Indian Journal of Ophthalmology, among others. International publications validating the solution's performance in Poland, Armenia, the Yucatan Peninsula, Africa, and the UK soon followed.

Remidio Medios AI's offline nature also eliminates the need for expensive GPU-based cloud servers, significantly reducing the digital infrastructure costs associated with providing equitable healthcare.