Fine Healthcare's Skinex Pressure Ulcer Device Designated as an Innovative Medical Device

Medical AI specialist company Fine Healthcare (CEO Shin Hyun-kyung) announced that its wound image analysis software, SkinEX_AI_Pulcer, developed by the company, has been designated as an 'Innovative Medical Device Medical Innovation Group' by the Ministry of Food and Drug Safety.

Innovative medical devices are medical devices that have significantly improved safety and effectiveness compared to existing medical devices or treatments, or that have innovative potential value due to the application of advanced technology with high technology intensity. This is an achievement that has been officially recognized as an advanced AI-based technology that contributes to improving patient safety and diagnostic accuracy.

Currently, this device is being used in many hospitals specializing in pressure ulcers, including Samsung Seoul Hospital, Sejong Chungnam National University Hospital, Kangwon National University Hospital, and Gachon University Hospital.
This device provides ▲ pressure ulcer stage assessment ▲ PUSH score-based diagnosis ▲ medication and treatment recommendation ▲ patient condition monitoring functions, significantly reducing the workload of nurses and demonstrating its effectiveness in increasing the accuracy of customized patient management.

SKINEX's non-contact method, which measures pressure ulcers with simple imaging, enables rapid and timely results, unlike the existing method, which relied solely on the individual judgment of medical professionals and had unclear management systems. Furthermore, by systematically collecting and analyzing pressure ulcer data, SKINEX can establish a pressure ulcer management system based on the quantified results. This can then be utilized in research to reduce pressure ulcer incidence and improve treatment methods.
In addition, it can shorten the recovery period of patients with pressure ulcers, reduce early diagnostic errors, and prevent the worsening of pressure ulcer conditions, thereby reducing the length of hospitalization, which accounts for the largest portion of pressure ulcer treatment, and alleviating the burden of medical expenses on patients and health insurance finances.
Patients often experience vague anxiety because they struggle to gauge whether their wounds are healing. By visualizing the healing process through photos, graphs, and numbers, Skinex allows patients to visually witness positive treatment progress, providing them with psychological stability and boosting their commitment to treatment. This helps patients better understand their condition and recognize the importance of self-management, potentially improving treatment compliance.
Medical staff can also maximize work efficiency by automating repetitive tasks required for pressure ulcer measurement and recording, and support smooth communication and decision-making among medical staff through standardized data.

Fine Healthcare Co., Ltd. is preparing to expand beyond hospital-centered clinical use to a home healthcare platform that will allow patients and their caregivers to systematically manage pressure ulcers at home. This integration will allow medical staff to remotely review and monitor photos taken by patients or their caregivers at home, potentially alleviating the burden of bedsore patients with limited mobility who need to visit the hospital for simple progress checks. This will establish a hospital-home-linked patient management system, contributing to a revolution in long-term patient care.

Interest in this device is growing in overseas markets, including Southeast Asia. Building on this momentum, Fine Healthcare plans to expand its overseas certifications and partnerships to become a global pressure ulcer management solution provider.

“This designation as an innovative medical device is not simply a commercialization achievement, but the starting point of medical innovation that can simultaneously improve patient safety and nurses’ work efficiency,” said Shin Hyun-kyung, CEO of Fine Healthcare Co., Ltd. “We will take the lead in improving the quality of life of patients and establishing international medical standards through home healthcare services and entry into the global market.”