CDSCO, India's national regulatory authority, approves the country's first Ophthalmic AI software – Remidio Medios DR AI that automatically detects referable Diabetic Retinopathy in retinal images.
BENGALURU, India, Sept. 13, 2024 -- Diabetic retinopathy (DR) affects one in three individuals with diabetes globally, and if left unchecked can cause irreversible blindness. With the global patient with diabetes (PWDs) population set to reach 642 million by 2040, the increasing burden of DR is likely to strain healthcare systems worldwide.
India needs to screen nearly 125 million PWDs annually for DR. With only one ophthalmologist per 100,000 patients, decentralizing screenings from ophthalmic centers to primary care physicians managing diabetes is essential.
United Kingdom has shown that DR can be prevented, even eliminated, through retinal cameras and teleophthalmology in primary care. India is advancing this by adopting cutting-edge AI that does not require internet for inferencing, along with portable and affordable retinal cameras for DR screening in primary care.
Remidio, a Bangalore headquartered company, with offices in India, US and Singapore, received CDSCO approval for its Medios DR AI, 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.
On the occasion, 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.
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."
Cost-benefit is particularly crucial for India, where diabetes-related blindness is estimated to cost the country INR 400 billion annually, as per the ORNATE 2023 report.
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."
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.
Dr. Divya Rao, Chief Medical Officer at Remidio and a Clinical Ophthalmologist sums up Remidio's vision on the pivotal approval: "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."
About Remidio Innovative Solutions Pvt. Ltd.
Remidio is an innovative ISO 13485-certified med-tech firm with offices in India, the US, and Singapore. Remidio seeks to prevent blindness by creating accessible technologies that are smart and simple to use. Remidio's portfolio of medical devices and AI solutions have helped screen and impact more than 15 million patients in 40+ countries globally. For further information, please visit www.remidio.com
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