[Edaily Reporter Kim Seung-kwon] The cardiovascular catheterization lab, where every second counts in emergency situations, is considered a veritable silent battlefield. In this high-pressure environment, where a patient’s life hinges on a doctor’s split-second decision, the true value of technology lies not merely in “how accurate it is,” but in “how quickly and conveniently it can assist doctors.”

MediPixel, a medical artificial intelligence (AI) company, has focused precisely on this area. With its core solution, “MPFFR,” recently selected as a technology eligible for a moratorium on the evaluation of new medical technologies, MediPixel is poised to leap forward as an industrial “game-changer” with a robust revenue model that goes beyond technological innovation.

The “7-second” magic that replaces invasive tests… Revolutionizing the procedure room workflow

MediPixel’s core competitive edge lies in MPXA and MPFFR, solutions for morphological and functional analysis based on coronary angiography images. In particular, the fractional flow reserve (FFR) analysis software MPFF, which has now been placed on the deferred evaluation track for new medical technologies, is recognized for its innovative potential to revolutionize the existing paradigm of cardiovascular disease diagnosis.

In the past, FFR testing—used to accurately assess stenotic lesions in the coronary arteries—was a highly invasive procedure that required inserting a pressure wire directly into the patient’s blood vessels and administering medication. This not only placed a physical burden on the patient but also entailed significant time and cost for preparation and testing. Consequently, it posed limitations in the catheterization lab, where every second counts.

In contrast, Medipixel’s MPFFR utilizes AI technology to calculate FFR values in just 7 seconds using only the contrast-enhanced images acquired during the procedure. Without any additional invasive procedures or drug administration, MPFFR rapidly and accurately determines the functional severity of the lesion through 3D vascular model reconstruction and hemodynamic calculations.

Song Gyo-seok, CEO of Medipixel, emphasized, “The procedure suite is like a fast-paced battlefield,” adding, “For this reason, our product maximizes usability for medical staff through automation that does not disrupt existing workflows and delivers results in just 7 seconds.” By providing fully automated analysis results instantly without any separate manipulation, physicians can focus entirely on patient care.

Furthermore, Medipixel’s solution is purely software-as-a-service (SaaS)-based and does not require bulky hardware, maximizing flexibility for hospital adoption. It can be easily integrated into existing imaging equipment or hospital servers, overcoming space constraints and significantly improving operational efficiency. This is seen as the decisive factor that allowed the solution to establish itself not just in the market for simple screening CTs used in health checkups, but right in the heart of procedure rooms where actual emergency patients are treated.

This confidence in the technology has led to plans to secure a vast amount of clinical data. It also reflects the company’s ambition to go beyond simply demonstrating the AI’s computational speed or accuracy and to prove its impact on patients’ medium- to long-term prognoses. Medipixel is currently conducting a large-scale prospective randomized controlled trial (RCT) involving 2,100 patients across 22 major general hospitals in South Korea, with Samsung Seoul Hospital serving as the lead institution.

If the company can demonstrate that patient treatment outcomes remain equivalent two to three years later when comparing the traditional invasive FFR test using a wire with the AI-based MPFFR test, Medipixel’s global competitiveness is expected to become even more solid.

The Economics of the New Medical Technology Evaluation Moratorium… Will It Recreate Vuno’s ‘DeepCAS’ Myth?

In the medical AI industry, the

new medical technology evaluation

moratorium system is regarded as a critical fast track that determines a company’s fate, going beyond a mere administrative procedure. This is because it serves as a magic key that instantly helps companies overcome the difficult period during which they were forced to supply products to hospitals free of charge or limit their use to research purposes only.

If selected for this program, companies can bill patients directly for test costs on a temporary, non-reimbursed basis in clinical settings for a minimum grace period of five years. From the hospital’s perspective, this creates a clear economic incentive to purchase the product, while the company secures a stable source of revenue (cash cow). The medical AI industry views Medipixel’s entry into the non-reimbursed market as having broken down the biggest barrier to adoption.

#Vuno’s AI cardiac arrest prediction solution, DeepCARS, is cited as the best example illustrating this economic impact. DeepCARS, which received a deferral of evaluation in 2022, drove explosive growth by accounting for 75% (approximately 10 billion won) of Vuno’s total revenue in 2023. DeepCARS is credited with successfully establishing a subscription-based (SaaS) business model. Medipixel expects MPXA and MPFFR to drive even greater performance growth than DeepCARS.

Furthermore, real-world evidence (RWE) accumulated daily in actual clinical settings through off-label use will serve as the most powerful asset for future inclusion in the official national health insurance coverage. Once deeply integrated into the system as a core decision-making tool in the procedure room, it will also benefit from a strong lock-in effect, making it difficult to switch to competing products.

CEO Song stated, “We expect the selection for the evaluation deferral to be a major boon in terms of sales,” adding, “Now that the barriers have been significantly lowered, we will demonstrate in the long term—through large-scale RCTs—that our products are on par not only in performance but also in patient outcomes.”