HippoT&C's "BlueKare" Designated as an Innovative Medical Device by the Ministry of Food and Drug Safety

AI-Based Depression DTx Proves Clinical Efficacy and Technological Maturity

Digital therapeutics specialist HippoT&C Co., Ltd. announced on the 4th that its mobile application for depression treatment, “BlueKare,” has been designated as an “innovative medical device (General No. 122, advanced technology group)” by the Ministry of Food and Drug Safety.

BlueKare recently obtained approval as a “new medical technology” from the Ministry of Food and Drug Safety and is scheduled to begin full-scale prescription this month, mainly at tertiary hospitals. With this latest designation as an innovative medical device, its entry into clinical settings is expected to gain further momentum.

This designation is regarded as official recognition by a national authority of BlueKare’s technological differentiation and its innovative value in clinical practice, as it uses artificial intelligence (AI) technology to manage and improve depression in daily life.

In this review, BlueKare was classified as an “advanced technology group” innovative medical device, demonstrating its unrivaled technological capabilities. This indicates that it goes beyond a simple medical device and is a product that integrates core technologies of the Fourth Industrial Revolution, such as AI and big data.

Used under prescription by medical specialists, BlueKare implements validated cognitive behavioral therapy (CBT) theories optimized for the mobile environment. In particular, through various techniques such as meditation, exercise, and AI-based conversations, it helps patients manage their depressive state without constraints of time and place. Its proprietary AI algorithm analyzes patient data in real time and provides personalized feedback, which is expected to complement the limitations of traditional face-to-face treatment and dramatically improve treatment adherence.

HippoT&C has secured technological reliability by complying with medical device information security standards (ISO 27001) and good manufacturing practice (GMP). It also applies the next-generation healthcare information standard FHIR to support seamless data integration with individual hospital systems. Through this, medical staff can immediately use patients’ remote treatment data in clinical care, and patients can experience more precise and personalized medical services.

HippoT&C CEO Jung Taemyung said, “This designation as an innovative medical device recognizes BlueKare’s potential as a game changer in the digital healthcare market,” adding, “We will continue to invest in research and development (R&D) to lead the global digital therapeutics market beyond Korea.”

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