UV Smart has officially received FDA 510(k) clearance for the D60, its UV-C high-level disinfection system for transesophageal echocardiography (TEE) probes. This milestone marks the first time a UV-C–based system has been cleared by the U.S. Food and Drug Administration for high-level disinfection of TEE probes
The D60 is designed to disinfect sensitive cardiology instruments using UV-C light, providing a validated alternative to traditional chemical-based reprocessing methods. While conventional cleaning and disinfection workflows can take up to two hours, the D60 delivers high-level disinfection in just two minutes. This represents a significant improvement in efficiency and workflow for healthcare providers, while reducing manual handling and eliminating the use of harsh chemicals.
“This clearance will help fulfill the need in U.S. healthcare for validated options that reduce manual workload, improve safety, and support more efficient clinical workflows,” said Thijs Kea, co-founder of UV Smart
With this FDA clearance, UV Smart enters the next phase of its international growth strategy and prepares for expansion into the United States. Active in 35 countries worldwide, the company continues to demonstrate how chemical-free, automated high-level disinfection can support both patient safety and operational efficiency in healthcare settings.
The D60 also contributes to long-term cost control by eliminating recurring chemical expenses and reducing wear and tear on valuable cardiology equipment. Together, these benefits position the D60 as a scalable solution for hospitals seeking to modernize reprocessing workflows without compromising regulatory compliance.
For access to the full press release, click here.
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