FDA OKs UV-C Disinfection Device for Endocavitary & External Ultrasound Probes

Germitec, a French company that specializes in high-level disinfection (HLD) for ultrasound probes though UV-C technology, has earned U.S. Food and Drug Administration (FDA) De Novo authorization for its Chronos automated disinfection device.
 
Chronos is a one-button, chemical-free automated device with proven safety and efficacy, the company claims. Its UV-C technology penetrates the membrane of microorganisms, disrupting their DNA, RNA, and cellular proteins. This stops their replication and capacity to infect, reducing the risk of cross-contamination.
 
The company said Chronos is the first, only UV-C HLD chamber FDA-cleared in the U.S. It’s indicated to achieve, in about 90 seconds, high-level disinfection at the point of care of surface of of external, transvaginal, and transrectal ultrasound probes that do not contain lumens and indentations or channels that are deeper than their widths.
 
These types of probes are widely used across various medical departments, including gynecology and IVF (in-vitro fertilization), urology, radiology, emergency medicine, anesthesia, and biopsy.
 
“Being granted FDA De Novo is an outstanding achievement for Germitec,” said Vincent Gardès, CEO of Germitec. “This milestone is the result of several years of hard work by a first-class team and our partners. We are excited to introduce this groundbreaking chemical-free technology to the world’s largest healthcare market. 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. Additionally, this Clearance paves the way for our future UV-C HLD products designed for long probes used in ENT and Cardiology departments.”