Alpha Intelligence Manifolds, specializing in AI-assisted diagnostic solutions for chronic musculoskeletal and cardiovascular diseases, announced that its latest product, DeepXrayTM Spina, was approved by Taiwan’s Food and Drug Administration (TFDA) in October. This marks the company’s fourth TFDA approval for software as a medical device (SaMD).
Since May 2023, Alpha Intelligence Manifolds has obtained seven SaMD approvals from regulatory authorities, including the U.S. FDA and TFDA, for solutions targeting degenerative arthritis and osteoporosis. Building on its robust R&D capabilities, the company plans to secure an additional two to three TFDA approvals by 2025, further expanding its AI-assisted diagnostic services.
DeepXrayTM Spina enables accurate bone mineral density (BMD) estimation for lumbar vertebrae L1-L4 using any X-ray images that include the lumbar region (e.g., abdominal or KUB X-rays). When combined with the previously approved DeepXrayTM Coxa, the system provides a comprehensive and precise BMD assessment of the axial skeleton regions most vulnerable to fracture-related disability and mortality: the lumbar spine and bilateral hips. This AI-powered solution aligns with the measurement standards of the gold-standard dual-energy X-ray absorptiometry (DXA).
According to Taiwan’s National Health Survey (2017-2020), 14.1% of individuals aged 65 and older—about one in seven—have osteoporosis in at least one measured site, with prevalence significantly higher in women (17.4%) compared to men (10.4%). For patients with osteoporosis, spinal compression fractures and hip fractures are the most critical risks. Approximately 10-25% of patients with hip fractures die within a year, 25% lose mobility, and over 40% require long-term assistance, imposing significant personal, familial, and societal burdens.
The DeepXrayTM Spina+Coxa solution targets the most critical regions for osteoporosis-related risks: the lumbar spine and bilateral hips. Its results demonstrate a high correlation with DXA measurements (correlation coefficient > 0.9, mean absolute error < 0.05 g/cm²), making it a valuable alternative for clinics lacking DXA equipment, local health centers, or healthcare facilities overwhelmed by high DXA demand. By automatically processing existing X-ray images, the system delivers highly accurate, real-time osteoporosis diagnostic support.
This year, Alpha Intelligence Manifolds partnered with Far Eastern Memorial Hospital and Shuang-Ho Hospital, successfully integrating DeepXrayTM into their clinical applications under the Joint Commission of Taiwan’s “Promotion of Domestic Medical Products in Healthcare Services” initiative. Both hospitals have reported significant achievements in applying the technology.
Additionally, Alpha Intelligence Manifolds’ Japanese subsidiary completed its registration on November 8, coinciding with the anniversary of Dr. Roentgen’s discovery of X-rays. The company is also advancing its Japanese regulatory approvals, aiming to secure its first SaMD certification in Japan by Q1 2025. Meanwhile, market promotion in Vietnam is progressing, with MEDIC, Ho Chi Minh City’s largest health screening center, actively trialing DeepXrayTM via VT Cloud Service. MEDIC’s radiology director, Dr. Kong, has expressed amazement at the system’s clinical performance.
Alpha Intelligence Manifolds remains committed to advancing the accessibility of precise AI-assisted diagnostics for high-prevalence chronic diseases, addressing the growing healthcare demands of an aging population. Through its DeepXrayTM product line, the company continues to tackle frontline clinical challenges, aiming to enhance the quality of life for elderly patients and their families affected by chronic conditions.
Resource: 采風智匯DeepXrayTM Spina骨質疏鬆症AI輔助診斷軟體獲TFDA許可
