HealthcareSmart Blood Analytics Swiss Achieves EU-MDR Certification for VIRUS vs. BACTERIA Model

In a significant stride towards preventing antimicrobial resistance, Smart Blood Analytics Swiss proudly announces the attainment of EU-MDR (European Medical Device Regulation)1 certification for their VIRUS vs. BACTERIA Clinical Decision Support Software. This innovative medical device sets a new benchmark in accurately distinguishing between viral and bacterial infections, thus aiding physicians in delivering targeted and effective treatment to patients.

Antimicrobial resistance (AMR) poses a significant threat to global public health and development, contributing to millions of deaths annually. Mainly driven by the misuse and overuse of antibiotics, AMR undermines the effectiveness of treatments for infectious diseases, putting modern medical advancements at risk and increasing healthcare costs substantially. The World Health Organization (WHO) emphasizes preventing infections, ensuring universal access to quality diagnosis and treatment, and promoting innovation in surveillance and research to address antimicrobial resistance in human health.

As the first Clinical Decision Support Software to receive EU-MDR certification in the field of infectious disease management, VIRUS vs. BACTERIA utilizes only 17 routine blood parameters, biological sex, and age to distinguish between viral and bacterial infections. The VIRUS vs. BACTERIA model has also recently been showcased in an article published in Heliyon, highlighting its effectiveness and great accuracy (https://doi.org/10.1016/j.heliyon.2024.e29372).

With routine blood testing being readily available worldwide, VIRUS vs. BACTERIA greatly expands the doctor’s capacity to differentiate between viral and bacterial infections and aids in the rational use of antibiotics, especially in the range where other commonly used blood markers offer limited diagnostic value.

The idea to develop VIRUS vs. BACTERIA was inspired by the 2022 G20 Bali summit, where a Call to Action on antimicrobial resistance was presented3. It emphasized the urgent need for innovative solutions to combat the growing worldwide threat of AMR, often referred to as the silent pandemic. This event convened global leaders to address the challenges, and it highlighted the importance of collaborative efforts to develop effective strategies for infection management.

Dr. Marko Notar, CEO of Smart Blood Analytics Swiss, shared his excitement about the EU-MDR certification, stating, “This achievement shows our commitment to advancing healthcare through innovation. By providing clinicians with a precise tool to differentiate between viral and bacterial infections, we aim to empower doctors with more information and help them in their decision of antibiotic prescriptions. This contributes to more effective healthcare practices.”

The EU-MDR certification process involves a thorough and extensive evaluation of medical device safety, quality, and compliance with European Union regulations governing medical devices. Smart Blood Analytics Swiss is committed to maintaining the highest standards of safety, performance, and compliance, and this EU-MDR certification reaffirms its ongoing dedication to excellence in the healthcare industry.

In an era where healthcare challenges demand innovative solutions, VIRUS vs. BACTERIA emerges as a solution of great promise. Being available to use worldwide and with its user-friendly interface and powerful capabilities, this cutting-edge tool stands ready to empower healthcare professionals in their battle against antimicrobial resistance.

PRNewswire

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