SaMD Approvals by MFDS — WALK101 Lineup Certification Update
WALK101 has organized its SaMD lineup based on MFDS approvals. Based on safety and performance verification as medical devices, we are fully promoting clinical implementation.
Hello, this is the WALK101 Newsletter.
In this issue, we share the news of Medical Device Approval from the Ministry of Food and Drug Safety (MFDS), an important milestone for the WALK101 SaMD lineup. Medical device approval is not just 'registration', but it means that the safety and performance have been systematically proven based on regulatory standards so that it can be used in actual clinical settings.
Core of this update
- ► Securing the reliability (safety/performance) stage of the SaMD lineup based on MFDS approval
- ► Class 1: HTO (new) / Cervical Spine (new)
Why is 'approval' important?
For medical device SaMD, an explanation that 'AI works well' is not enough. Because it can directly or indirectly affect patient data and clinical decision-making, it must be operated with risk management, quality control, performance basis, and change management according to regulatory standards. This approval means that WALK101 has met these requirements step by step.
WALK101 SaMD Lineup Summary
Through this lineup reorganization, WALK101 has structured its product group more clearly around GMSM, an AI-based musculoskeletal X-ray image analysis software. In particular, with HTO and Cervical Spine newly included, the analysis scope required in clinical fields has been expanded. We plan to gradually expand the pipeline 'starting from necessary areas, centered on clinically meaningful indicators'.
Next Step
What matters now is not just ending at 'receiving approval', but accumulating operational experience so that it can be used naturally within actual hospital workflows (PACS/EMR). WALK101 will continuously advance the product in a direction that simultaneously increases stability in the clinical environment.