ActiMedi Aims to Launch Digital Medical Device 'KneeFresh' in the First Half of Next Year

Regulatory Approval Progress Achieved Just 17 Months After Development Initiation

On September 3, ActiMedi, a digital healthcare platform company, announced that it is accelerating the commercialization of its digital medical device 'KneeFresh,' which supports home rehabilitation exercises for patients with knee osteoarthritis, by smoothly advancing the regulatory approval process.

KneeFresh is a Class II stand-alone software medical device (SaMD) designed to assist home rehabilitation exercises aimed at improving pain in patients with knee osteoarthritis. Patients can use their mobile device cameras to perform exercise movements without any need for wearable sensors or dedicated exercise equipment. The solution was developed to provide follow-up exercises and ongoing management based on movement and pain data. Currently, a pivotal clinical trial is underway, and the device is at the pre-market authorization stage.

ActiMedi established the design and development plan for KneeFresh in January 2025 and initiated development. In June of the same year, the company submitted a preliminary inquiry to the Ministry of Food and Drug Safety (MFDS) regarding its classification as a digital medical device, and then filed a clinical trial application (IND) in August. Subsequently, ActiMedi verified the product's performance, usability, and cybersecurity, establishing a technical and quality management framework to obtain regulatory approval. Notably, on December 24, 2025, the MFDS gave final approval to proceed with the pivotal clinical trial for KneeFresh without requiring a separate exploratory trial (Digital Medical Device Clinical Trial Plan Approval No. 20).

The pivotal clinical trial targets 112 patients with knee osteoarthritis, with recruitment completed at the end of last month. ActiMedi plans to finish follow-up observation of participants by December this year, followed by statistical analysis and preparation of the clinical trial report, aiming to apply for digital medical device marketing authorization in the first half of 2027.

The development of this product has been supported by the collaboration of professionals with deep understanding of clinical settings and advanced technological expertise. In particular, Jin Koo Kim, an orthopedic surgeon with extensive clinical experience in the field of knee joints and CEO of ActiMedi, has guided the product development, ensuring that essential functions and usability required in real medical environments are reflected in KneeFresh.

Jin Koo Kim, CEO of ActiMedi, stated, "KneeFresh is a product born out of nearly 30 years of clinical experience as a physician treating patients and observing their recovery process. We aim to successfully complete the ongoing regulatory approval procedures and officially launch KneeFresh in the first half of 2027."

This content was produced with the assistance of AI translation services.