Actimedi accelerates commercialization of digital knee rehab device KneeFresh

Digital healthcare platform company Actimedi is pushing ahead with the commercialization of its digital medical device KneeFresh.

Actimedi said Thursday that regulatory approval procedures for KneeFresh, a digital medical device designed to support at-home rehabilitation exercises for patients with knee osteoarthritis, are progressing smoothly.

KneeFresh is a Class 2 standalone software medical device, or SaMD, developed to support home-based rehabilitation exercises aimed at relieving pain in knee osteoarthritis patients.

The device works by having patients perform exercises using a mobile device camera, then uses the movement and pain data collected to guide follow-up exercises and ongoing management. The company said the product is currently undergoing a confirmatory clinical trial and has not yet received product approval.

According to Actimedi, the company drew up a design and development plan for KneeFresh in January 2025 and began development. In June of that year, it submitted a preliminary inquiry to the Ministry of Food and Drug Safety to confirm whether the product qualified as a digital medical device, and filed an investigational new device application in August.

The company subsequently verified the product's performance, usability and cybersecurity, and established a technical and quality management framework for regulatory approval.

KneeFresh received final approval of its confirmatory clinical trial plan from the Ministry of Food and Drug Safety on Dec. 24, 2025 — without requiring a separate exploratory clinical trial. The approval was designated as Digital Medical Device Clinical Trial Plan Approval No. 20.

Actimedi said the outcome reflected its argument that the product uses a non-invasive, contactless method relying solely on a mobile device camera, and that the exercise interventions it provides are already recommended in clinical guidelines issued by major international medical societies.

The confirmatory clinical trial involves 112 knee osteoarthritis patients. Actimedi completed recruitment of its target participants by late August and plans to finish follow-up observation in December, after which it will conduct statistical analysis and prepare a clinical trial results report. The company intends to apply for digital medical device product approval in the first half of 2027.

"KneeFresh grew out of nearly 30 years of clinical experience treating patients and watching them recover," said Kim Jin-gu, CEO of Actimedi. "Our goal is to complete the ongoing regulatory process without a hitch and bring KneeFresh to market in the first half of 2027."

Actimedi is an AI- and data-driven digital healthcare platform company built by a team of orthopedic and sports medicine specialists alongside an IT team. The company aims to deliver personalized rehabilitation solutions drawing on more than 26 years of research and patient experience. Kim, who also serves as director of Myongji Healthcare, leads the product development direction as CEO and works to incorporate the functions and usability needed in clinical settings.