Establishing a foothold in the U.S. Medical Device Market

AITRICS(CEO Kwang joon Kim), a company specializing in artificial intelligence (AI) technology announced on the 6th that its inpatient monitoring software, AITRICS-VC (VitalCare), has received FDA 510(k) clearance.

AITRICS-VC is a clinical decision support system(CDSS) that integrates with hospitals' electronic health record (EHR) systems, enabling healthcare professionals to monitor real-time changes in patients' conditions. This software features an intuitive dashboard that allows clinicians to quickly identify patients in critical condition and review their comprehensive medical history for proactive treatment. 

Additionally, AITRICS-VC enhances the accuracy of early warning scores, such as the Modified Early Warning Score (MEWS), National Early Warning Score (NEWS), and quick Sequential Organ Failure Assessment (qSOFA), helping medical staff predict patient deterioration.

The software is the first of its kind in South Korea to gain FDA approval for alarm functions that can predict mortality and cardiac arrest under the FDA's Software as a Medical Device (SaMD) criteria. Aitrics views this approval as a significant milestone for its entry into the U.S. market.

Looking ahead, AITRICS plans to rapidly expand its product lineup by adding new AI models for predicting acute kidney injury and patient deterioration in emergency rooms, supported by ongoing clinical trials in the U.S.

Dongyeop Kim, RA/QA Manager at AITRICS, said "Amid the strengthening of SaMD review standards, including medical device cybersecurity, our product has met the key requirements of the FDA. This approval marks a stepping stone for us to enhance the quality of our products and fully enter the U.S. market. And he added "We will do our best to provide valuable medical services to healthcare professionals and patients around the world, starting from South Korea and expanding to the U.S., Europe, and Asia.'

Kwang-joon Kim, CEO of AITRICS said "I believe this achievement is the result of ongoing discussions and support from various government agencies to enhance our understanding of the U.S. market. The FDA approval will serve as a bridge for medical devices made in Korea to enter the global market." 

Currently, AITRICS-VC is actively used in over 50 hospitals in South Korea to predict risks of sepsis, cardiac arrest, and mortality, with plans to integrate AI into the product gradually for the U.S. market. Aitrics also established a subsidiary in Virginia last December to accelerate its U.S. expansion.