The Central Drugs Standard Control Organisation (CDSCO), the national regulatory body for cosmetics, pharmaceuticals and medical devices in India, has approved Remidio’s ophthalmic AI software Medios DR AI.
The software, first launched in 2018, can detect referable Diabetic Retinopathy (DR) automatically in retinal images.
Medios DR AI is used with portable retinal cameras. The tool can be used offline enabling detection of referable DR without internet access.
Additionally, the use of the solution eliminates the need for the deployment of GPU-based cloud servers and reduces the digital infrastructure costs.
The ophthalmic AI software is currently being used in some remote areas in India.
Remidio Regulatory Affairs & Quality Assurance senior VP Sundeep Agarwal 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.”
Remidio’s AI algorithms have undergone more than nine independent prospective clinical trials between 2017 and 2024 in partnership with several eye care and primary care partners across India.
The Medios DR AI also received CE marking under EU-MDR guidelines and HSA approval in Singapore in 2022.
Globally, one in three diabetic individuals is affected by diabetic retinopathy (DR). The condition can cause irreversible blindness if left unchecked.
According to Remidio, every year, India needs to screen nearly 125 million patients with diabetes (PWDs) annually for DR. The introduction of Medios DR AI is expected to facilitate decentralising screenings and help managing diabetes.
