Objectives: To validate the operational and diagnostic performances of a new device for transient elastography (TE), FibroTouch, for liver fibrosis in patients with chronic hepatitis B (CHB). Methods: In this prospective multicenter study, adult patients with CHB and valid liver pathological results were recruited to validate the operational and diagnostic performance of a TE device by FibroTouch for staging liver fibrosis. Results: In total, 517 patients with histologically proven CHB were enrolled. All had achieved at least 10 successful liver stiffness measurements (LSM), resulting in a success rate of 99.1% and reliable evaluations of 95.2%. Altogether 412 patients were included to analyze the diagnostic performance of FibroTouch. The area under the receiver operating characteristic curve for the LSM was 0.846 (95% confidence interval [CI] 0.808‐0.880) for fibrosis stage ≥ F1, 0.850 (95% CI 0.811‐0.883) for ≥ F2, 0.908 (95% CI 0.876‐0.934) for ≥ F3 and 0.874 (95% CI 0.836‐0.903) for F4. The diagnostic accuracy of LSM was superior to that of gamma‐glutamyl transpeptidase‐to‐platelet ratio (GPR), aminotransferase‐to‐platelet ratio index (APRI), or fibrosis index based on 4 factors (FIB‐4) index in staging fibrosis F2‐F4 (P = 0.007 to < 0.0001). Optimal LSM cut‐off values for diagnosing fibrosis stage ≥ F1, ≥ F2, ≥ F3, and F4 were 5.5 kPa, 7.85 kPa, 10.0 kPa, and 12.7 kPa, respectively. Conclusion: FibroTouch has a high success rate and good reliability in staging liver fibrosis in patients with CHB. [ABSTRACT FROM AUTHOR]