ANNOUNCEMENT: Smart Blood Analytics Swiss achieves EU-MDR certification for the VIRUS vs. BACTERIUM

(Information sent by the signatory company).

ANNOUNCEMENT: Smart Blood Analytics Swiss achieves EU-MDR certification for the VIRUS vs. BACTERIUM

(Information sent by the signatory company)

- A turning point in the battle against antimicrobial resistance

ZÜRICH, April 29, 2024 /PRNewswire/ -- In a significant step towards preventing antimicrobial resistance, Smart Blood Analytics Swiss proudly announces obtaining EU-MDR (European Medical Device Regulation)1 certification for its software support for clinical decision making VIRUS vs. BACTERIUM. This innovative medical device sets a new benchmark in accurately distinguishing between viral and bacterial infections, helping doctors offer targeted and effective treatment to patients.

Antimicrobial resistance (AMR) poses a significant threat to global public health and development and contributes to millions of deaths each year. Primarily driven by the misuse and overuse of antibiotics, antimicrobial resistance undermines the effectiveness of treatments for infectious diseases, putting modern medical advances at risk and substantially increasing healthcare costs. The World Health Organization (WHO) emphasizes preventing infections, ensuring universal access to quality diagnostics and treatments, and promoting innovation in surveillance and research to address antimicrobial resistance in human health.2

As the first clinical decision support software to receive EU-MDR certification in the field of infectious disease management, VIRUS vs. BACTERIA uses only 17 routine blood parameters, biological sex and age to distinguish between viral and bacterial infections. The VIRUS vs. model BACTERIA has also been recently presented in an article published in Heliyon, highlighting its effectiveness and great precision. (

Since routine blood tests are available worldwide, VIRUS VS. BACTERIA greatly expands the clinician's ability 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 of ​​developing VIRUS vs. BACTERIAS was inspired by the 2022 G20 Bali Summit, where a call to action on antimicrobial resistance was presented3. He highlighted the urgent need for innovative solutions to combat the growing global threat of antimicrobial resistance, often referred to as the silent pandemic. This event convened global leaders to address challenges and highlighted the importance of collaborative efforts to develop effective strategies for treating infections.

Dr. Marko Notar, CEO of Smart Blood Analytics Swiss, shared his excitement about the EU-MDR certification, saying: "This achievement shows our commitment to advancing healthcare through innovation. By providing physicians with "Accurate tool to differentiate between viral and bacterial infections, we aim to provide physicians with more information and assist them in their decision about antibiotic prescribing, contributing to more effective healthcare practices."

The EU-MDR certification process involves a thorough and extensive evaluation of the safety, quality and compliance of medical devices 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 continued dedication to excellence in the healthcare industry.

In an era where healthcare challenges demand innovative solutions, VIRUS vs. BACTERIA emerges as a very promising solution. Being available for use worldwide and with its easy-to-use interface and powerful capabilities, this cutting-edge tool is ready to empower healthcare professionals in their battle against antimicrobial resistance.

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Acerca de Smart Blood Analytics Swiss:

Smart Blood Analytics Swiss is a forward-thinking healthcare technology company dedicated to transforming the medical diagnosis process. Its EU-MDR certified flagship product, SBAS Software, employs artificial intelligence to improve the accuracy and efficiency of interpreting blood test results. With a commitment to excellence and a focus on patient well-being, Smart Blood Analytics Swiss is at the forefront of innovation in the healthcare sector and continually develops new products in the field of interpretation of blood test results. This includes pioneering solutions that provide a deeper dive into understanding and recommending which blood parameters contribute to decisions that determine the correct diagnosis for the patient.

To learn more about how Smart Blood Analytics Swiss can help transform the medical diagnostic process, visit:

1 Regulation (EU) 2017/745 on medical devices2

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