aetherAI Announces CE Mark for World’s First Bone Marrow Differential AI System

​​​​​​​ aetherAI, Asia's leading medical image AI solution provider, today announced CE Mark for aetherAI Hema, for automatic differential counting of bone marrow smears. In collaboration with the National Taiwan University Hospital (NTUH), aetherAI Hema has received the Taiwan Food and Drug Administration (TFDA) approval and Taiwan's Ministry of Health and Welfare's approval to commercialize this AI diagnostic tool. This is the first approval case for automatic differential counting on bone marrow smears.

The differential count of blood cells is the basis of diagnostic hematology. In many circumstances, the identification of cells in bone marrow smears is the gold standard for diagnosis. However, morphological assessment and differential count of bone marrow smears are still performed manually. These procedures are tedious, time-consuming, and laden with high inter-operator variation.

To solve these issues, aetherAI Hema has been specifically developed to automate the procedure of bone marrow smear differential counting, benefiting all leukemia patients.

According to the WHO International Agency for Research on Cancer, Asia accounts for 54 percent of the world's leukemia cancer mortality—a percentage much higher than other regions. aetherAI has teamed up with NTUH, the leading medical center in Asia, as well as top experts in hematology disease in Taiwan. NTUH has collected bone smear samples since 1983, and its leukemia patients across Taiwan account for about one-third of these contributions.

Trained on the world's largest dataset of over 1 million carefully curated cells, aetherAI Hema is able to perform consistently, with a high average accuracy of 94 percent. Each cell will be classified into one of 15 main categories. Results are readily available with just a few clicks.

"aetherAI Hema is the best solution for automatic differential counting of bone marrow smears on the market," said Dr. Wen-Chien Chou, Department of Laboratory Medicine, National Taiwan University Hospital. "Although some have tried to use AI to solve this issue since 1997, those tools have limitations with certain diseases, low number of annotated cells for datasets, and other variables. aetherAI Hema's receiving TFDA approval, Taiwan's highest medical authority, shows its value in clinical practices and meets the needs of hematologists."

"We're proud to have obtained this milestone CE Mark for aetherAI Hema Automatic Differential Count of Bone Marrow Smears, the world's first bone marrow differential AI system. It's aligned with our mission of developing AI solutions for AI-powered diagnostic support via state-of-the-art technology to elevate the standard of medical imaging diagnosis and improve the quality of care," said Dr. Joe Yeh, aetherAI co-founder and CEO. aetherAI Hema provides high efficiency and increased consistency of differential count of bone marrow smears. The verified results can be saved in the system and further used for educational purposes or collaborations between medical technicians and hematologists.

Founded in October of 2015, aetherAI is ranked number one in the digital pathology and AI market in Taiwan. Since 2017, aetherAI has been tripling its annual revenue for three years in a row, actively exploring the global market in places like Japan, the Middle East, and the United States. aetherAI-supported research has been published in prestigious international journals. These journals include <Machine Learning Based on Morphological Features Enables Classification of Primary Intestinal T-Cell Lymphomas> by Cancers and <An Annotation-free Whole-slide Training Approach to Pathological Classification of Lung Cancer Types by Deep Neural Network> by Nature Communications.


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