Needle-Free Injector

May 15, 2026 by Leave a Comment
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[INQ. NO. 2605E05] JSKBIOMED Inc. is a biomedical company specializing in laser-based, needle-free injection technology, developing next-generation drug delivery solutions that address the limitations of conventional injection methods ― including pain, infection risk, and medical-waste generation.
Based on proprietary technology that precisely controls the skin barrier using laser energy, the company has established a platform capable of effectively delivering drugs, vaccines, and functional substances, with scalability across medical, aesthetic, and healthcare fields.

Following the stabilization of its core technology in 2025, JSKBIOMED has begun full-scale expansion into overseas markets, entering major countries including Japan, Poland, and Sweden. In Korea, the technology is currently being applied in approximately 300 hospitals and clinics, thereby, demonstrating both technical stability and clinical applicability.
JSKBIOMED recently introduced its laser-based, needle-free injection technology and new product lineup ― aiming to expand strategic partnerships with overseas distributors, medical device companies, and pharmaceutical and biotech firms. The company has been seeking to release collaboration models tailored to country-specific distribution structures and market characteristics while building long-term global networks.
JSKBIOMED’s flagship medical product, MiraJet, utilizes laser-based needle-free injection technology to deliver drugs and active ingredients effectively while minimizing skin damage. It is designed to reduce pain and infection risk while lowering dependency on practitioner skill, thereby enabling a more consistent treatment environment.
JSKBIOMED also recently introduced its aesthetic equipment Jetical Pro 2940, which presents a solution optimized for professional treatment settings. Based on precise laser- control technology, it supports stable energy delivery and enhanced treatment control, and is designed to improve skin condition and increase the efficiency of active ingredient delivery. It can be applied to various skin types and treatment purposes, expanding its usability in professional clinics.

In addition, JSKBIOMED is expanding into the homecare market with the Jetical Mini Pro, a consumer device that integrates the core technology of its medical and professional equipment. Designed with enhanced usability and safety, it enables personalized skincare management, forming an integrated laser-based needle-free injection solution ecosystem across medical, professional, and home-use categories.
JSKBIOMED has identified the United States, Japan, China, France, and Germany as key target markets. These countries represent mature medical and aesthetic device markets with continuously increasing demand for high-performance and high-value aesthetic technologies. The company plans to pursue phased market expansion through collaboration with local buyers, distributors, and global beauty and biotech companies.
In the first half of 2026, JSKBIOMED will be participating in major international exhibitions such as AMWC Monaco and ASLMS in order to strengthen global brand recognition, while promoting its technology and expanding partnerships.
At the same time, JSKBIOMED will pursue country-specific regulatory approvals and certifications in stages and accelerate its growth as a global laser-based needle-free injection platform company through technology licensing, joint development, and diversified collaboration models.

 
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AI-based Personalized Pelvic-Wellness Platform

May 15, 2026 by Leave a Comment
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[INQ. NO. 2605E04] MBLab is an innovative technology company that develops solutions to improve women’s quality of life through AI- and data-based digital healthcare technologies. Focusing on women’s pelvic health and wellness (Pelvic Wellness), the company combines medical expertise with user experience to expand its presence in the global Femtech market.
With the vision of understanding women through AI and data, and redefining health in life, MBLab aims to evolve into a personalized health management platform.
MBLab’s core mission is built on scientific, evidence-based technology development, user-centered health experience design, and global market expansion. By utilizing data and AI, the company develops personalized health solutions while incorporating the insights of medical professionals to deliver practical wellness experiences. At the same time, it is accelerating global expansion through overseas distribution and strategic partnerships.

In Korea, MBLab has already supplied its VVP3500 diagnostic device and RT4000 urinary incontinence treatment system to 250 hospitals, where they are actively used in clinical settings.

In Japan, MBLab has exported its AI- and data-based pelvic-health solution Ekegel, thereby establishing a foothold in the market. Through participation in MEDICA 2025 and CES 2026, the company has drawn interest from global buyers, and is advancing its international marketing efforts.
MBLab recently introduced locally not merely a conventional Kegel device, but an AI-based personalized Pelvic Wellness Platform. The solution is structured as an intelligent pelvic floor management system that integrates measurement, analysis, personalized exercise, and feedback. It analyzes contraction, endurance, and relaxation data, incorporates a 12-item vaginal health checklist, classifies users based on AI algorithms, and automatically sets optimal exercise intensity tailored to each individual.
The platform is positioned as a clinically recognized product used in hospitals and medical channels. By going beyond a simple exercise device and providing a data-driven continuous management system, it enhances the precision of women’s health management. It is applicable to various conditions, including urinary incontinence, postpartum recovery, and pelvic health management for middle-aged women.
MBLab aimed at increasing awareness of AI-based pelvic health solutions in the domestic healthcare market, discovering hospital, clinic, and distribution partners, and gathering feedback from medical professionals in order to further refine its products. At the same time, the company seeks to strengthen domestic references to support its global expansion strategy.
MBLab’s global strategy will proceed in three phases: first, establishing a foundation for entry into the North American market; second, expanding in Japan and securing entry opportunities in Europe; and third, targeting premium markets in the Middle East and China.
Following participation in MEDICA 2025 and CES 2026, MBLab plans to attend CES 2027 and healthcare exhibitions in Dubai, while continuing to expand its domestic and international network through participation in future KIMES events.
Through its AI-based personalized pelvic-health management platform, MBLab aims to present a new standard in women’s wellness and strengthen its competitiveness in the global Femtech market as a data-driven technology company.


 
 
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Digital Therapeutics

May 15, 2026 by Leave a Comment
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Accelerating Global DTx Market Expansion
[INQ. NO. 2605E03] Beyondmedicine Co., Ltd. is an AI-based Digital Therapeutics (DTx) company founded in 2022, developing prescription-based digital treatment solutions focused on chronic and recurrent Temporomandibular Disorder (TMD).
Recognizing that TMJ disorders are difficult to manage through single, clinic-centered treatments alone, Beyondmedicine has introduced its core product, ClicklessDTx, a digital therapeutic designed to improve patients’ daily behavioral correction and treatment adherence.
By integrating Cognitive Behavioral Therapy (CBT) technology, the platform objectively collects and analyzes patients’ rehabilitation exercise performance and symptom changes ― providing an integrated digital-treatment system that enables clinicians to manage treatment progress beyond the clinic.
Through ClicklessDTx, Beyondmedicine conducted the world’s first Randomized Controlled Trial (RCT) targeting temporomandibular disorder patients and published the results in the SCI-indexed international Journal of Dentistry, thereby demonstrating its clinical efficacy.

It also obtained designation as an Innovative Medical Device from the Korean Ministry of Food and Drug Safety (MFDS), becoming the first digital therapeutic device in the dental field to receive such recognition in Korea. The company has completed domestic medical device approval for its TMJ digital therapeutic device. Overseas, it completed the U.S. FDA Pre-submission process and received recognition as a Novel Technology, thus securing a foundation for global regulatory approval.
Beyondmedicine recently presented a hospital-prescription-based digital-treatment model centered on ClicklessDTx. It emphasized that the solution can operate in conjunction with conventional physical therapy, thereby simultaneously improving hospital-treatment efficiency and revenue structure. Locally, it showcased real clinical data and a clinician-exclusive dashboard to explain product differentiation and practical application, while seeking early-adopter medical institutions and global partners.

ClicklessDTx is a prescription-based digital-treatment system integrating into a single platform home-based rehabilitation, behavior modification, symptom tracking, treatment feedback, and clinical reporting. Patients perform therapeutic programs in daily life while accumulating data, and clinicians can systematically monitor treatment progress and adherence outside the hospital through a dedicated clinician dashboard. The system is designed to complement the limitations of episodic treatment and enhance treatment continuity and management efficiency.
Users are expected to achieve clinically validated improvements through 5–10 minutes of daily program participation over six weeks. The treatment process is visualized through data-based interfaces, allowing both patients and clinicians to intuitively track therapeutic changes.
Beyondmedicine has identified the United States, Japan, and major European countries as key target markets. The United States represents a high-acceptance market with an established regulatory framework for digital therapeutics, and the company is pursuing initial entry based on FDA approval procedures. Japan faces increasing demand for chronic pain and rehabilitation solutions due to population aging, while Europe’s evidence-based healthcare system provides a favorable environment for RCT-based digital therapeutic adoption.
Going forward, Beyondmedicine plans to advance full-scale commercialization of ClicklessDTx in Korean hospitals and gradually expand global market entry in accordance with U.S. FDA regulatory processes. The company will also strengthen global partnerships through participation in international dental and digital health exhibitions and conferences, while expanding its pipeline beyond TMJ digital therapeutics into facial paralysis rehabilitation and broader dental and oral healthcare areas. To support this expansion, the company is preparing for Series-A investment fundraising.

 
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Photorealistic 3D Avatar-Based Body-Analysis Solution

May 15, 2026 by Leave a Comment
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[INQ. NO. 2605E02] VBody was founded by the Yonsei University Computer Graphics Lab to address the subjectivity of body-shape assessments and the inconsistencies in tracking physical changes that frequently occur in fitness centers, Pilates studios, and clinics.
Traditional visual assessments and 2D photo-based consultations often vary, depending on the evaluator, resulting in inconsistent explanations and reduced persuasiveness when presenting before-and-after results. Leveraging computer-vision and 3D neural rendering-based human digitization technology, VBody has commercialized a solution that generates photorealistic 3D avatars and standardized body metrics from a simple capture process, enabling not just ‘visible change’ but also ‘measurable and explainable change.’
Since its official launch in December 2025, VBody has established a nationwide sales and supply system, offering packaged solutions that combine 3D scanning hardware and AI-powered body-analysis software to B2B clients including fitness centers, Pilates studios, and clinics. On-site workflows ― from capture, to 3D avatar generation, body metric calculation, and before-and-after comparison reporting ― have been standardized to minimize operational burdens.
VBody recently introduced its technology locally, as a solution capable of simultaneously achieving objective body and posture evaluation and enhanced patient communication in medical and healthcare settings. The company emphasizes that its photorealistic 3D avatars and AI-based analytical metrics generated from brief capture sessions can shorten consultation times, while presenting treatment and exercise outcomes according to consistent standards.
VBody’s body-analysis and change-tracking solution enhances consultation persuasiveness through 3D visualization and provides AI-based standardized metrics, ensuring consistent evaluation, explanation, and tracking regardless of practitioner or branch location. Objective data is delivered by posture estimation-based key-point analysis, joint and trunk-angle measurements, and proportional indicators ― while accumulated longitudinal data and before-and-after comparison reports intuitively demonstrate treatment and exercise outcomes. This approach has attracted industry interest for its potential to support re-visits and re-registration performance.

VBody has identified the United States, Japan, and the Middle East as priority overseas markets. The United States represents a rapidly expanding market for digital health and data-driven fitness consultations. Japan, facing rapid aging, has strong demand for rehabilitation and posture correction and a high acceptance of standardized reporting. The Middle East is characterized by active investment in premium healthcare and fitness infrastructure, with growing interest in advanced equipment that enhances customer experience.
Looking ahead, VBody plans to expand nationwide distribution in 2026, while establishing a partnership framework capable of supporting repeat adoption. The company is preparing for global expansion with a target of participating in CES 2027. Based on domestic field references, VBody aims to further refine product completeness and establish a new standard for 3D-based body digitization in the global healthcare and fitness markets.

 
 
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AI-Based Smartwatch

May 15, 2026 by Leave a Comment
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Targeting Both Industrial Safety and Elderly Care
[INQ. NO. 2605E01] Innomes is a technology company providing smart healthcare solutions designed to protect workers in industrial environments and vulnerable populations in densely populated settings.
Centered on its AI-powered smartwatch InnoCare System, Innomes is expanding simultaneously into industrial safety and elderly healthcare markets through an IoT smartwatch equipped with multi-sensor technology.
The InnoCare System collects and analyzes real-time biometric data via nine embedded sensors in the smartwatch, including heart rate and body temperature. The system is designed to detect early-warning signs of heatstroke, overexertion, and cardiac abnormalities ― particularly in high-temperature, high-humidity, or physically demanding work environments. Data is transmitted in real time to an AI-based integrated monitoring platform, where abnormal patterns trigger immediate alerts to administrators, thereby assisting in the prevention of serious industrial accidents.

Innomes successfully developed its safety and health management system for major accident prevention through the Ministry of SMEs and Startups’ Smart Manufacturing Innovation R&D Program. The solution has been supplied to small and medium-sized manufacturers in the Changwon National Industrial Complex and to Changwon Leports Park, thereby establishing domestic reference cases. Building on this foundation, the company signed MOUs with Thai manufacturing firms AOSSAWIN and SETTHAMOUSHOL in Bangkok through the Gyeongnam Changwon Defense Innovation Cluster overseas export support program, and is currently advancing discussions.
Innomes recently locally presented the InnoCare System as a first step toward establishing a safety and health management system under the Serious Accidents Punishment Act. Beyond industrial sites, the company will emphasize its scalability as a real-time health monitoring solution for elderly individuals living alone, and populations vulnerable to heat-related illnesses.
Through its administrator-mode integrated monitoring dashboard, the system enables comprehensive data analysis across worksites and supports AI-based predictive risk management.
Innomes has identified Thailand and Japan as key target markets for overseas expansion. Thailand is experiencing increasing smartwatch adoption and demographic aging, creating growing demand from elderly care facilities, hospitals, and healthcare institutions.
The company is pursuing collaboration with local medical firm Chalerm Prakarn Group and exploring potential partnerships with Bangkok Hospital and global medical tourism platforms.
Japan, one of the world’s most rapidly aging societies, presents strong demand for elderly health and safety management solutions. Innomes is preparing for market entry through a partnership with Omron Corporation and is strengthening localization strategies by collaborating with AI-based personalized care solution providers.
Starting in 2026, Innomes plans to participate sequentially in major domestic and international exhibitions including MEDICA, Medical Fair Asia, etc. Through these platforms, the company aims to expand its global buyer and partner network, establish regulatory and certification strategies for local markets, and accelerate overseas market entry aligned with customized product development.
By integrating industrial safety and elderly healthcare into a unified framework, Innomes seeks to build a data-driven preventive healthcare ecosystem powered by AI-based biometric monitoring technology.

 
 
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Korea’s Exporters

May 15, 2026 by Leave a Comment
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Korea’s Exporters Continuing Astounding Growth

Releasing Globally Competitive New Items

Korea’s exports have broken all-time records for the month of April, boosted by the global expansion of artificial intelligence (AI) infrastructure.
The nation’s exports in April recorded $85.89 billion, a 48.0% increase compared to the same month last year. Imports rose by 16.7% to $62.11 billion, resulting in a surplus of $23.77 billion in trade balance. With this, Korea set a record by surpassing $80 billion in exports and $20 billion in trade balance for the first time in history.

The undisputed star contributor was semiconductors. As global investment in AI infrastructure expanded, massive demand emerged for both NAND and DRAM, causing semiconductor exports to surge by a staggering 173.5% year-on-year to reach $31.9 billion. This marks the highest monthly record for the 13th consecutive month. The computer (SSD) sector also showed growth, increasing by 515.8% due to an explosion in demand for data centers driven by the spread of AI.

Korea’s Competitive New Items Attracting Keen Attention of Potential Buyers
Korean companies are ceaselessly launching new products. Striving to achieve their export performance goals for this year, creative efforts are being made to engage in the development of competitive products.
VBody recently introduced its technology locally, as a solution capable of simultaneously achieving objective body and posture evaluation and enhanced patient communication in medical and healthcare settings. The company emphasizes that photorealistic 3D avatars and AI-based analytical metrics generated from brief capture sessions can shorten consultation times, while presenting treatment and exercise outcomes according to consistent standards.

MBLab recently introduced locally not merely a conventional Kegel device, but an AI-based personalized Pelvic Wellness Platform. The solution is structured as an intelligent pelvic floor management system that integrates measurement, analysis, personalized exercise, and feedback. It analyzes contraction, endurance, and relaxation data, incorporates a 12-item vaginal health checklist, classifies users based on AI algorithms, and automatically sets optimal exercise intensity tailored to each individual.
 
 
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Digital Therapeutic Device for Improving Nicotine-Use Disorders

April 15, 2026 by Leave a Comment
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[INQ. NO. 2604E07] Innerwave Inc. is a software technology company that has grown through extensive experience in providing IT services both for public institutions and major corporations. Through continuous research and development, the company has expanded into the digital healthcare sector ― focusing on AI-based diagnostic support, treatment, and monitoring solutions, as well as AI healthcare platforms. Leveraging its expertise, Innerwave has concentrated on digital medical device development and related services.
Recently, Innerwave received regulatory approval from the Ministry of Food and Drug Safety (MFDS) in Korea for its digital therapeutic device for nicotine-use disorders, under the brand name of Dr. JinNicojini. This product is a mobile app–based digital therapy prescribed to patients after being diagnosed by psychiatric or family medicine specialists. It is structured as an eight-week program grounded in Cognitive Behavioral Therapy (CBT), combining coping strategies for nicotine cravings with motivational-enhancement training to support patient self-management in daily life.

Dr. JinNicojini is a product developed to apply cutting-edge technology through innovative medical device approval ― and it has secured content differentiation based on personalized features. The app delivers personalized content through a stepwise eight-week treatment protocol designed to facilitate behavioral change. By collecting and analyzing digital patient data, it supports adherence monitoring and sustained engagement throughout the treatment process. It is significant in that it is a digital therapeutic device that has obtained regulatory approval in Korea, with the goal of improving people’s nicotine-use disorders.
Building on its experience in developing disease-management applications and patient-management platforms for high-level general hospitals, Innerwave plans to expand its domestic clinical references following commercialization. By promoting the adoption of its innovative medical technology in healthcare institutions, the company aims to accumulate real-world clinical cases and strengthen synergies with its broader AI healthcare platform business.
For its overseas expansion strategy, Innerwave has set the German Digital Health Application (DiGA) market as its primary target. To this end, it is preparing to obtain CE MDR certification, as it believes Germany is a market where the regulatory integration of digital therapeutic devices can occur relatively quickly compared to other countries. After securing sufficient domestic references, we plan to pursue a phased expansion into the European and Southeast Asian markets.
Innerwave plans to expand its portfolio of disease-specific digital therapeutic devices based on its digital medical-device development service capabilities and AI-based platform technology.
Starting with Dr. JinNicojini Genie, the company intends to advance its technological competitiveness and business model in the field of digital therapy, and accelerate its entry into the global digital healthcare market.
Innerwave has obtained regulatory approval for software medical devices, achieving development milestones in digital medical devices, mobile health, and AI disease prediction systems—backed by AI-based development infrastructure and clinical data from medical institutions. “We are committed to driving global digital biohealth innovation through our comprehensive one-stop integrated service utilizing medical platforms, AI, and Big Data Cloud technologies,” remarked the company’s CEO.

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Digital Therapeutics

April 15, 2026 by Leave a Comment
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[INQ. NO. 2604E06] Founded in 2016 as a spin-off from Samsung Electronics, WELT specializes in digital therapeutics, developing digital-healthcare solutions that combine medical expertise with advanced IT technologies based upon the concept of ‘Wellness Technology.’ The company adheres to the core principle of developing clinically validated software medical devices and has expanded its business based on products that have demonstrated safety and efficacy through regulatory approval.
WELT has developed digital therapeutics for insomnia and eating disorders, and is advancing an ‘AI Combo Drug’ strategy that integrates digital treatment with conventional pharmaceutical therapies. By leveraging AI to analyze patient data, the company aims to optimize medication timing and manage treatment adherence, embedding digital technology throughout the entire patient-care journey.
In 2023, WELT obtained approval from Korea’s Ministry of Food and Drug Safety (MFDS) for its insomnia treatment, digital therapeutic SleepQ, establishing a foundation for commercialization in Korea. The company has since collaborated with pharmaceutical firm Handok to expand prescriptions and distribution across domestic medical institutions, promoting a new treatment approach that combines digital therapeutics with conventional medication.

Mobile-based Digital Therapeutic Treatment
SleepQ is a mobile-based digital therapeutic treatment that delivers Cognitive Behavioral Therapy for Insomnia (CBT-I), traditionally administered in person at hospitals. Designed as a six-week treatment program prescribed by medical professionals, SleepQ analyzes patients’ sleep diaries and behavioral data to provide personalized treatment plans.
The platform integrates core CBT-I components such as sleep restriction, stimulus control, cognitive restructuring, relaxation therapy, and sleep-hygiene education. Through a connected system comprising a patient app and a clinician dashboard, healthcare providers can monitor and manage the treatment process efficiently.

Clinical trial results have demonstrated its effectiveness. After seven weeks of treatment, patients using SleepQ showed an average 15.14% improvement in sleep efficiency and a reduction of over 55% in sleep onset latency, confirming meaningful improvements in sleep outcomes.
WELT recently also showcased DrugOS, its AI-powered drug optimization platform. DrugOS analyzes patients’ physiological and behavioral data in order to recommend optimal medication timing and dosage adjustments tailored to changes in the patient’s condition.
DrugOS implements a ‘Just-in-Time’ medication-management model by identifying disease progression patterns and optimizing medication schedules accordingly. An AI agent continuously interacts with patients to collect additional data, refining treatment strategies over time. This approach enables pharmaceutical companies to enhance therapeutic outcomes by integrating digital technology with existing drugs, without altering the drugs themselves.
In recognition of its technological innovation, WELT received a CES Innovation Awards 2026 honor, drawing global attention in the digital healthcare sector.
WELT is actively expanding into global markets. In Europe, the company has established a local subsidiary in Germany, and is conducting clinical trials for adult insomnia patients in collaboration with Charité – Universitätsmedizin Berlin, one of Europe’s largest university hospitals. WELT has also secured CE certification and ISO 27001 certification, thereby reinforcing its data security and medical device quality-management systems.

In the United States, WELT is expanding its partnerships with global pharmaceutical companies through board-level engagement with the American Telemedicine Association (ATA) and is strengthening its digital healthcare ecosystem through joint research with Oura Health.
In the Middle East, the company is exploring market entry opportunities through discussions with regulatory authorities in the UAE and engaging potential partners at global exhibitions such as WHX Dubai.
Looking ahead, WELT plans to enhance SleepQ with expanded AI capabilities in SleepQ 2.0 and broaden its digital therapeutic pipeline beyond insomnia to include eating disorders, migraines, diabetes, hypertension, and other chronic conditions.

 
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AI-based Software as a Medical Device

April 15, 2026 by Leave a Comment
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[INQ. NO. 2604E05] a.cure Co., Ltd. is a digital healthcare company developing AI models that predict disease risk based on voice analysis. Established in June 2024 by a team with experience in developing Korea’s first digital therapeutic device, Somzz, the company is currently advancing by developing AI-based Software as a Medical Device (SaMD), Heart to Voice, designed to analyze the voices of heart-failure patients and high-risk groups. The solution aims to detect early warning signs, prevent emergency events, and reduce hospital readmissions.
Rather than focusing on a single product, a.cure is building a comprehensive digital medical ecosystem that spans early screening ―> diagnostic support ―> post-discharge monitoring. In the long term, the company plans to integrate traditional pharmacological treatments such as diuretics, smartphones, and mobility services to create cross-industry healthcare synergy.
a.cure is currently conducting exploratory clinical trials to further refine Heart to Voice. In the first half of this year, a.cure is advancing with the development of a 90-day prescription-based monitoring AI SaMD for heart failure patients following hospital discharge. In the second half of the year, the company aims to apply for approval through the Korean Ministry of Food and Drug Safety’s Integrated Review Program for Innovative Medical Devices.

Global expansion efforts are also underway. In the first half of the year, a.cure plans to conduct Proof-of-Concept (PoC) projects in collaboration with Medstown in India and PMK Group in Singapore, integrating Heart to Voice into local chronic-disease management platforms. In the second half of 2026, the company intends to apply for the U.S. FDA Breakthrough Devices Program (BDP).
a.cure recently unveiled its 90-day prescription monitoring AI SaMD for post-discharge heart failure patients, and is currently seeking domestic and international distribution and sales partners. The company will conduct product demonstrations and technical briefings targeting pharmaceutical companies, diagnostic firms, and digital health platform operators, while exploring strategic collaborations for overseas PoCs and commercialization.

Digital Cardiopulmonary Product
Heart to Voice is a digital medical product that analyzes approximately 10 seconds of speech using only a smartphone, without requiring additional medical equipment. The AI quantifies biological signals embedded in vocal data ― such as breathing patterns, subtle vocal tremors, and acoustic energy distribution ― closely related to cardiopulmonary function. Based on this analysis, heart-failure severity is classified into four stages ― Normal, Mild, Moderate, and Severe. Exploratory clinical trials have demonstrated predictive performance with an AUC of approximately 95%.

Because the solution is non-invasive and allows for repeated measurements, it can be used in daily life outside the hospital setting. This makes it particularly suitable for continuous monitoring after discharge and for early detection in high-risk populations, positioning it as a next-generation digital-health technology.
Globally, heart failure affects an estimated 120 million people. Approximately 24 million patients are located across five major markets: Korea, the United States, China, Japan, and Singapore. Considering patient population size, as well as digital health adoption, and healthcare accessibility, a.cure has identified the United States, Japan, China, India, Indonesia, and Singapore as key target markets. The company plans direct SaMD entry into the United States and Japan, while pursuing a phased market approach in China, India, Indonesia, and Singapore through partnerships with chronic-disease management platforms based on an “early cardiac-risk detection” wellness service model.
“We will continue enhancing the accuracy of our AI-based heart failure severity model and expanding global validation datasets to strengthen our technological credibility. Through expanded domestic and international distribution partnerships and participation in major global exhibitions ― including MEDICA 2026, SWITCH 2026, and CES 2027 (Innovation Awards application) ― we will accelerate our growth as a global leader in medical AI,” explained the company’s CEO.
 
 
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AI-Based Medical Imaging Solutions

April 15, 2026 by Leave a Comment
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[INQ. NO. 2604E04] Silla Systems Co., Ltd., founded in 2005, is a software- and AI-based medical device solution company that has expanded into the digital healthcare sector by balancing its legacy software development capabilities with advanced medical artificial-intelligence technologies.
Since 2010, Silla Systems has steadily secured technologies and patents related to medical image analysis. Based on this foundation, it has developed and is commercializing AI-powered medical imaging solutions including its Pine-DX, Walnut-DX, and AIVis-Q.
In 2024, Silla Systems obtained K-GMP certification and medical device manufacturing certification for Pine-DXC (PDC-01), establishing a compliant medical-device manufacturing and quality management system.

Silla Systems is actively conducting product validation and refining service models in collaboration with major domestic hospitals and mass-screening institutions, while gradually expanding real-world applications through research-oriented deployments.
For overseas expansion, Silla Systems has acquired ISO 13485 certification and completed Class-B medical-device registration in Vietnam, as well as medical-device distribution approval in Indonesia. Building on these milestones, the company began exporting products to a Vietnamese distributor in 2025, laying the groundwork for international market entry.

Through participation in overseas exhibitions and partner development activities, Silla Systems has signed MOUs with approximately 10 companies and is in discussions with over 30 buyers regarding potential collaboration models.

Multi-skeletal Disorder Diagnostic Support & Integrated Analysis Software
Silla Systems’ flagship product, Pine-DX, is a multi-skeletal disorder diagnostic-support and integrated-analysis software solution. The system is designed to allow modular or integrated use, depending on the needs of medical institutions and screening centers. Key functions include scoliosis analysis (Cobb’s angle and Nash-Moe analysis), bone-age assessment, ankle instability and knee ligament injury analysis, and flatfoot measurement.
The solution is designed to generate multiple analytical results from a single image, thereby enhancing diagnostic efficiency and providing clinically relevant data during the consultation process. Performance metrics include vertebral recognition accuracy measured by the mean Average Precision (mAP) of 97%, Cobb’s angle diagnostic accuracy of 95.74%, average analysis time of approximately 1.09 seconds, and mean absolute error (MAE) of 0.67 years in hand bone-age assessment.

AI-based Brain-Tumor Detection & Clinical-Decision Support System
Another core solution, Walnut-DX, is an AI-based brain-tumor detection and clinical-decision support system. It analyzes brain imaging data and provides quantitative insights to assist physicians during the diagnostic process.
Silla Systems views 2026 as a pivotal year for expanding its global footprint and has identified Vietnam as its primary overseas target market. Vietnam’s growing economy, increasing healthcare expenditure, and reliance on imported medical devices ― approximately 90% of the market ― present strong growth potential for digital healthcare solutions. Additionally, the Vietnamese government’s push to adopt digital medical technologies further strengthens market demand.
Silla Systems is currently in discussions with GH Vietnam, a local medical-device distributor, and Ibone Fiso, a medical device company operated by orthopedic specialists, regarding product-introduction and pricing strategies. These efforts are aimed at taking advantage of opportunities to supply products to local hospitals and medical institutions.
To further expand internationally, Silla Systems is pursuing regulatory approvals in additional countries including Thailand and Uzbekistan. It also aims to secure approvals for expanded product lineups by the first half of 2026.
Silla Systems is strengthening its overseas exhibition strategy, with planned participation in K-Med Expo Vietnam 2026, Indonesia HOSPITAL EXPO 2026, and Uzbekistan UZMEDEXPO 2026. Through these events, Silla Systems intends to identify local partners, conduct product demonstrations, and refine solutions in line with market needs.
 
 
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