PR in the Philippines

Airdoc Technology (2251.HK) Receives EU CE MDR Certification, Securing Market Access in Multiple Countries

On January 8th, Airdoc Technology announced that its Airdoc-AIFUNDUS (1.0) has recently obtained the CE marking (“CE MDR”) as per the Medical Device Regulation, allowing comprehensive market entry into 27 EU countries, including Belgium, Germany, Italy, France, and more.

In addition to obtaining CE MDR, Airdoc-AIFUNDUS (1.0) and AI-FUNDUSCAMERA-P (AI-FD16 series) have successfully received regulatory approvals from various international agencies in Southeast Asia, the Middle East, and Africa over the past two years. Specifically, Airdoc-AIFUNDUS (1.0) is approved or registered in Indonesia, Vietnam, South Africa, the United Arab Emirates, and Malaysia. AI-FUNDUSCAMERA-P has obtained regulatory approval or registration in Indonesia, South Africa, the United Arab Emirates, and Thailand.

According to the IDF Global Diabetes Map (10th edition), approximately 537 million adults (20-79 years old) worldwide suffered from diabetes in 2021, with a global prevalence of around 10.5%, meaning one in every ten adults is a diabetic patient.

Airdoc-AIFUNDUS (1.0) is designed to assist in diagnosing diabetic retinopathy, being the first in China to receive the National Medical Products Administration’s Class III medical device certificate and the world’s second AI-based retinal image recognition and analysis medical device software to be approved.

The company’s self-developed AI-FD16 series of fundus cameras is China’s first fully automatic, self-service, portable fundus camera to be approved for market release. It can easily be applied in any medical and health scenario, providing essential hardware support for widespread and accessible retinal screening.

With market access permits obtained from various countries and regions, China’s original AI technology is set to travel across the globe, benefiting local residents and making health ubiquitous.

In Europe, approximately 61.4 million people have diabetes, with an adult diabetes prevalence of about 9.2%. The highest incidence of Type 1 diabetes in Europe is among children and adolescents, reaching 295,000 people, with an annual incidence rate of 31,000 new cases. The average per capita expenditure for diabetes patients in Europe is the second-highest globally at $3,086. Early diagnosis of diabetes and its complications can effectively reduce treatment costs.

Diabetes statistics for 2021 indicate that Thailand has around 6.1 million adult (20-79 years old) diabetes patients, ranking fourth in the Western Pacific region. Malaysia has approximately 4.4 million adult diabetes patients, ranking fifth in the Western Pacific region. Indonesia has the world’s fifth-highest number of adult diabetes patients in 2021, estimated at 19.5 million, projected to increase to 28.4 million by 2024. The number of undiagnosed adult diabetes cases in 2021 ranks third globally, with approximately 14.3 million cases, representing a 73.7% undiagnosed rate. South Africa has around 4.2 million adult diabetes patients, the highest in Africa. Vietnam witnessed a 43% increase in diabetes patients from 2019 to 2022, with the current number reaching 5 million, making it one of the top ten causes of disability in Vietnam. The UAE has nearly one million people with diabetes, with a prevalence rate of about 12.3%, and nearly 30% of Dubai residents have diabetes or prediabetes.

Diabetes is a significant chronic disease faced by humanity, and overcoming it is a collective challenge. Airdoc Technology’s software and hardware products obtaining more market access permits from various countries aim to take retinal image AI detection services beyond China, striving to reduce the risk of illness for people worldwide. Connecting with the common aspiration for a disease-free world, the company aims to truly achieve “health everywhere.”