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06 April, 2023
News
Crescom’s MediAI-BA, a company specializing in artificial intelligence medical image analysis solutions, has obtained medical device approval from Malaysia’s MDA.

(Photo: artificial intelligence bone age analysis software, MediAI-BA _ ⓒ Crescom Co., Ltd.)


 

(Date: April 6, 2023)

 

Crescom (CEO Jae Joon Lee), a company specializing in the automatic analysis of artificial intelligence medical images, announced that it had obtained medical device registration for MediAI-BA from Malaysia MDA (Medical Device Authority, Ministry of Health Malaysia). The acquisition of the Malaysian certificate is significant as it provides an opportunity to enter the Malaysian market, which is continuously growing with a significantly high GDP growth rate among ASEAN countries.

 

MediAI-BA is a hybrid artificial intelligence growth plate analysis solution that combines the strengths of existing bone age reading techniques (GP and TW3) while addressing their weaknesses. This solution assists medical staff in accurate and quick diagnosis by increasing the efficiency and accuracy of growth plate bone age analysis in children and adolescents. Currently, about 250 medical institutions actively use MediAI-BA with very high satisfaction, and the number of institutions using it is rapidly increasing.

 

In addition to MediAI-BA, Crescom offers other artificial intelligence medical solutions specialized in musculoskeletal image analysis: MediAI-FX (automatic detection of fracture regions and analysis of fracture probability, including difficult-to-read scaphoid fractures), MediAI-OA (knee arthritis severity automatic analysis solution), and MediAI-AS (ankylosing spondylitis automatic evaluation solution). Crescom's technology has confirmed the excellent performance of these solutions.

 

Meanwhile, Crescom's MediAI-BA obtained certification from the Ministry of Food and Drug Safety(MFDS) and ISO13485:2016 in 2020 prior to obtaining medical device registration in Malaysia. CEO Jae Joon Lee said, “Following this Malaysian authorization, we intend to contribute to expanding access to innovative high-quality medical services in Southeast Asia, including Singapore, where the authorization process is currently underway. Furthermore, we are expanding our export products, including knee arthritis severity automatic analysis artificial intelligence solution, and pushing for entry into the American market as well as Asia."