Remidio receives CDSCO approval in India for Medios DR AI

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Remidio, received CDSCO approval for its Medios DR AI, which 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 is an offline AI that detects referable DR without requiring internet access. This is allowing it to be used in some of India's most remote areas, bringing essential eye care to communities that previously had limited access.

Sundeep Agarwal, Remidio's Senior VP of Regulatory Affairs & Quality Assurance, spoke about this approval in the company’s press release, saying, "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."

Between 2017 and 2024, more than 9 independent prospective clinical trials were completed on Remidio's AI algorithms, in partnership with multiple eye care and primary care providers across India. These trials were published in several journals such as JAMA Ophthalmology, Nature Eye, and the Indian Journal of Ophthalmology, among others.

Sankara Nethralaya's Senior Vitreo-Retinal Consultant Dr. Rajiv Raman, states, "A science-first, public health approach has helped Remidio not only assess the performance of its AI in real-world settings, but also for the AI research ecosystem to learn from clinical outcomes associated with primary care-led DR screening programs, care-gap closure pathways, and the cost-benefit analysis of bringing screening closer to the patient."

Dr. Rengaraj Venkatesh, Chief Medical Officer at Aravind Eye Hospital, adds, "Remidio's solutions are enabling over 50 healthcare workers to screen patients for diabetic retinopathy at Aravind's primary eye care or vision centres. These technologies not only enhance community health but also create job opportunities, as they are user-friendly and easy to learn, contributing to significant economic benefits for the nation."

Dr. Divya Rao, Chief Medical Officer at Remidio and a Clinical Ophthalmologist sums up Remidio's vision on the pivotal approval in this way, "The CDSCO's approval helps us bring care closer to patients, but we are particularly excited to see India become a global leader in leveraging AI to eliminate preventable blindness caused by DR.”

Reference:

India brings early Diabetic Retinopathy detection to the last mile with Artificial Intelligence. Remidio Innovative Solutions Pvt Ltd. September 13, 2024. Accessed October 8, 2024. https://www.prnewswire.com/in/news-releases/india-brings-early-diabetic-retinopathy-detection-to-the-last-mile-with-artificial-intelligence-302247453.html