Vuno said Monday that it became the first local firm to receive Conformite Europeenne Mark (CE) for its artificial intelligence (AI)-based medical device, VUNO Med®-Bone Age.
|VUNO Med®-Bone Age|
The device determines a patient's bone age by recognizing patterns on an X-ray image and marking its similarities with 58 standard reference images -- 31 males and 27 females. Combined with hormone levels and other information, doctors can use the machine’s information to diagnose precocious puberty and slow growth
The company has proved the efficacy of the system after a clinical trial. The test showed that the AI device and doctors had an average difference rate of 0.9 months. However, the manufacturer has designed the equipment to update images and learn from them periodically, which in turn will narrow the gap with doctors, Vuno said.
“With the CE certification, VUNO Med®-Bone Age can now enter the European market,” the company said. “Also, the certification will allow us to advance into other markets such as Southeast Asia and the Middle East.”