Ever Fortune AI Technology Co., Ltd. announced on the 21st that its Endotracheal Tube Depth Detection System (EFAI CHESTSUITE XR MALPOSITIONED ETT ASSESSMENT SYSTEM) has received U.S. FDA clearance for medical use. Simultaneously, the company has also submitted an application for market approval from Taiwan’s TFDA.
The system functions as a computer-aided triage and notification software, utilizing deep learning algorithms to automatically analyze chest X-ray images. It highlights and alerts potential vertical malposition of endotracheal tubes (ETTs) at the carina. When an ETT misplacement is detected, the system proactively sends alerts to PACS/RIS workstations, enabling healthcare professionals to identify and respond to mispositioned ETTs more rapidly than conventional clinical workflows. This early intervention capability can significantly enhance patient safety and improve clinical outcomes.
CGI has experienced significant financial growth, reporting record-breaking revenue of NT$345 million in 2024, a 270% year-over-year increase. January 2025 alone saw revenue of NT$20 million, marking an 81% annual growth rate. To date, CGI has secured 44 medical device approvals worldwide, including 13 from the U.S. FDA, 16 from Taiwan’s TFDA, 5 from Thailand, 5 from Malaysia, 4 from Vietnam, and 1 from Singapore.
CEO Lee You-Cheng emphasized that CGI holds the highest share of FDA and TFDA medical device approvals among Taiwanese companies. Furthermore, the company has recently been designated as an investment partner under Taiwan’s Ministry of Economic Affairs Small and Medium Enterprise Administration (SMEA) Investment Enhancement Program. This status allows CGI to co-invest with government funds in high-potential SMEs, fostering industry innovation.
Looking ahead, Lee stated that CGI will strategically evaluate competitive domestic and international biotech firms to direct capital investments that drive Taiwan’s AI-driven medical advancements, support industry growth, and optimize capital utilization.
Resource:長佳智能氣管內管深度檢測系統 獲美國FDA醫材許可
