French medtech Germitec has received de novo clearance from the US Food and Drug Administration (FDA) for Chronos, its high-level disinfection (HLD) device for ultrasound probes.
Chronos comes in the form of an automated, one-touch disinfection chamber that uses ultraviolet-C (UV-C) light to disinfect ultrasound probes in around 90 seconds. It is suitable for disinfecting the surfaces of external, transvaginal, and transrectal ultrasound probes that do not contain lumens and indentations or channels deeper than their widths.
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Such probes are used across a range of medical applications in hospitals, including gynaecology and IVF, urology, and radiology.
The overall aim of Chronos is to reduce cross-contamination and the incidence of healthcare-associated infections (HCAIs) such as hepatitis B and human papillomavirus (HPV).
According to Germitec, the UV-C light technology used in the device can penetrate the membrane of microorganisms to disrupt their DNA, RNA, and cellular proteins, thereby halting their replication and ability to infect.
The Centers for Disease Control and Prevention (CDC) has found that HCAIs are associated with almost 99,000 deaths in US hospitals annually, while the World Health Organization (WHO) estimates that up to 70% of HCAIs could be prevented with effective infection prevention and control measures.
With the FDA approval, Chronos has become the first and only UV-C chamber approved for market distribution in the US.
Germitec CEO Vincent Gardès commented: “With the successful completion of the rigorous FDA de novo process, our UV-C HLD solution offers validated microbial kill efficacy, providing healthcare facilities with a trusted option to protect their patients across all departments where ultrasound exams are performed.”
Germitec was established in Bordeaux, France in 2005. According to GlobalData, the medtech currently has two marketed HLD systems – Antigermix AE1 and Antigermix AS1, which are available in Australia, Canada, and certain European countries, including the UK and France.
Additionally, GlobalData’s Market Size and Growth database found that the global handheld ultrasound systems segment, of which ultrasound probes are a part, was valued at $481m in 2023. The segment is forecast to reach a valuation of almost $570m by 2033.
