VinBrain's DrAid™ product has officially been cleared by the US Food and Drug Administration (FDA). It is also the first and only AI product for X-ray Diagnostics in Southeast Asia to own this important certification, bringing Vietnam into the Top 6 countries with FDA-approved AI products for chest X-ray diagnosis.
FDA – The “international passport” for DrAid™
On September 2, 2022, VinBrain was officially recognized by FDA with the highest quality and safety standards. "This is a worthy result for the continuous efforts during the past three years of the VinBrain team," said Truong Quoc Hung, CEO of VinBrain, when receiving a notice from the US "medical gatekeeper".
DrAid™ is the first and only AI product for chest X-ray diagnosis in Vietnam and Southeast Asia that meets FDA standards so far. Before Vietnam, only five countries, namely the US, Israel, India, South Korea, and Australia, have businesses making AI products for X-ray diagnostics that have achieved this rigorous FDA certification.
For a long time, FDA certification has been likened to a mandatory "passport" for manufacturers, medical equipment distributors, or wishing to export healthcare-related products worldwide. To meet FDA standards, products must pass a series of extremely rigorous and rigorous detailed evaluations of quality to ensure absolute safety when operating in practice. For each field, the number of officials participating in the inspection can be up to more than 1,000 investigators and inspectors and more than 2,000 scientists.
With FDA Clearance, DrAid™ - a product owned by Vietnamese people - has been legally allowed to do business in the US market. Not only firmly doing business in the US, with the "gold guarantee" from the FDA, the made-in-Vietnam "AI assistant" also has the opportunity to expand its business globally.
DrAid™ is certified by the US Food and Drug Administration (FDA)
The crystallization of Vietnamese wisdom
Established in 2019, in a short time, DrAid™, the first AI technology product for the healthcare industry developed by Vietnamese people, has achieved remarkable achievements. VinBrain's medical imaging software currently owns the largest data set in Vietnam with 2.3 million images, of which 400 thousand labeled images have received the consensus of a panel of over five years of experience doctors.
Experimental results show that DrAid™ helps medical staff to automatically screen 21 lungs, heart, and bone abnormalities based on straight chest X-ray film within 15 seconds with an average accuracy of 91,2%. The solution also supports the classification and localization of liver cancer lesions on CT images with an average accuracy of over 95%.
Nearly 2,000 doctors use the application at more than 100 hospitals across Vietnam, including Hospital 108, Hospital 199, Hospital K, and University Hospital of Medicine and Pharmacy in Ho Chi Minh City. Up to now, DrAid™ has proven outstanding performance by contributing to saving 80-85% of initial screening time and increasing diagnostic accuracy rate up to 25%.
DrAid™ is being widely used in major hospitals across the country
"Natural aromatherapy," in the context of AI, is believed to be the key to reducing pressure on the medical team, increasing diagnostic accuracy, and providing equal medical opportunities for billions of people. Many large international organizations have also actively sought out DrAid™.
Recently, FINDDX has chosen to test DrAid™ before applying it on a global scale. If passing the rigorous tests from FINDDX, VinBrain's DrAid™ will be certified and have the opportunity to work with medical staff to help billions of patients around the world, especially in places where according to statistics Still, up to 10% of patients die or are seriously injured because of misdiagnosis.
VinBrain co-operates with many major international partners in the research and implementation of DrAid™.
Meanwhile, the leading artificial intelligence marketplace Ferrum, USA, has added DrAid™ to its portfolio of AI-based products for X-rays to help deliver the highest quality patient care.
In the coming time, with the "international passport" issued by the FDA, VinBrain is ready for its development plans to new heights, namely, scaling up the AI application solution in the medical field in different locations. Target markets include Southeast Asia, Europe, and North America. It is also a meaningful step that contributes to affirming the level of Vietnamese intelligence and Vietnamese brand in the international arena.