Ever Fortune. AI announced on the 11th that its "Bone Age Assessments" has received approval from the U.S. FDA. This brings the company's total to 35 medical device approvals globally, including 11 from the U.S. FDA, 14 from Taiwan's TFDA, 4 each from Thailand and Vietnam, and 1 each from Singapore and Malaysia.
Ever Fortune. AI's General Manager, Li Youzheng, highlighted that the "Bone Age Assessments" eliminates the time-consuming process of manual atlas comparison traditionally performed by clinicians, providing quick bone age analysis results and recommendations. This product had already received TFDA approval in 2021, and the recent FDA approval marks a significant milestone for its international market expansion.
In terms of financial performance, Ever Fortune. AI reported revenues of NT$115 million for the first five months of this year, surpassing the total annual revenue of the previous year and setting a new record with a 433% year-over-year increase. Despite a first-quarter net loss of NT$0.19 per share, market analysts are optimistic about the company's potential to achieve profitability this year.
On the international collaboration front, Ever Fortune. AI is partnering with Singapore-based kidney disease medical device company AWAK to co-develop an AI model for predicting kidney disease progression, which has been designated as a breakthrough device by the FDA. This model is currently undergoing testing and clinical preparations on the Mayo Clinic Platform. This collaboration aims to provide robust clinical data support for the AI model, enhancing its accuracy and reliability in predicting kidney disease progression.
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