UV Smart Announces FDA 510(k) Clearance for D60 TEE Probe Disinfection System

Business

UV Smart Announces FDA 510(k) Clearance for D60 TEE Probe Disinfection System

2026-02-09 23:10 Last Updated At：02-10 13:33

RIJSWIJK, Netherlands--(BUSINESS WIRE)--Feb 9, 2026--

The Netherlands-based MedTech company UV Smart has officially received clearance from the United States Food and Drug Administration (FDA). With this 510(k) clearance, UV Smart is launching its groundbreaking UV-C technology for the high-level disinfection of TEE probes in the United States: The D60 is the first UV-C high-level disinfection device in the world to receive FDA clearance for this application.

Click to Gallery

UV Smart's UV-C light

UV Smart D60 with TEE probes

UV Smart D60

Founder UV Smart

More Images

UV Smart's UV-C light

UV Smart D60 with TEE probes

UV Smart D60

Founder UV Smart

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260209198084/en/

What started as an innovative idea between two friends, has quickly grown into an international organization that is now active in 35 countries and is the market leader in its segment. With the support of investor Chris Oomen (founder of Optiver), UV Smart proves that Dutch innovation can make healthcare better and affordable worldwide.

From hours to minutes

The FDA clearance applies to the UV Smart D60: A system that disinfects medical TEE probes, sensitive medical instruments for heart examination used in cardiology, with UV-C light. Where current cleaning & disinfection with harsh chemicals can often take approximately two hours, the D60 achieves high-level disinfection in just two minutes using UV-C light. For healthcare providers, the D60 represents a significant improvement in efficiency and workflow; the D60 is the first device of its kind to receive FDA 510(K) clearance for high-level disinfection of TEE probes.

“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,” says co-founder Thijs Kea.

Efficiency as a revenue model

UV Smart is redefining hospital efficiency, seamlessly scaling facility capacity while fortifying safety for healthcare workers. Its equipment enables faster disinfection cycles, allowing more patients to be treated per day. In addition, the system eliminates the cost of chemicals and reduces wear & tear on costly cardiology equipment.

With its entry into to the United States, UV Smart is entering the next phase of its international growth strategy. UV Smart is demonstrating that chemical-free high-level disinfection can support both operational efficiency and long-term cost control in healthcare settings.

About UV Smart

UV Smart Technologies B.V. is a Dutch MedTech company that makes healthcare safer and more affordable with innovative UV-C high-level disinfection products. Since its founding in 2017 by Daan Hoek and Thijs Kea, the company has grown into an international player with approximately thirty employees in the Netherlands, Germany and the United Kingdom.

The portfolio, consisting of the D25, D45 and D60, is specifically aimed at the disinfection of cardiology, gynecology, TEE and ENT equipment respectively. UV Smart now supplies hospitals and clinics in 35 countries. With the forthcoming expansion to the United States, the company is aiming for strong global growth.

Images:More images of the D60 and its founders are available on request.

About the 510(k) approval:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251354

Denny Hamlin storms back to win at Las Vegas after early penalty

LAS VEGAS (AP) — Denny Hamlin returned to victory lane at Las Vegas Motor Speedway on Sunday for his first win since he lost the NASCAR championship four months ago, and first since the death of his father in a December house fire.

“I knew it took a few weeks to feel like driving,” Hamlin said after his 61st career victory. “Over the last couple weeks, I definitely regained my love of it, got refocused. These are great opportunities for us.”

Hamlin's 60th career victory was at Las Vegas last October, a win he dedicated to his father as it locked Hamlin into NASCAR's championship-deciding finale. His father was in poor health and Hamlin went into the race knowing it was probably his final chance to win a championship while Dennis Hamlin was still alive.

Then Hamlin dominated last year's title-decider at Phoenix Raceway but the wrong call on the final pit stop cost him the Cup championship that has eluded the three-time Daytona 500 winner.

What followed was an emotional rollercoaster: Hamlin, as co-owner of 23XI Racing, was part of the winning team in a federal lawsuit against NASCAR last December. Weeks later, his father was killed in a fire that destroyed the home Hamlin purchased to thank his parents for getting him into NASCAR.

He returned for the start of his 21st season and went to victory lane as an owner with Tyler Reddick when the 23XI Racing driver won the Daytona 500 and then set a NASCAR record by winning the first three races of the year.

Most of the attention went to 23XI co-owner Michael Jordan as Reddick won Daytona, Atlanta and Circuit of the Americas.

Hamlin did his part at Las Vegas to put himself back in the spotlight.

“It is just so satisfying, so gratifying. You just never know what can happen year over year if you still have it or not," said Hamlin. “I wasn’t totally locked in for the first few weeks. We’ve just been hitting our stride now. This is our bread and butter, these are the tracks that we know we can go win, and we executed. This is a team win. The team did it.”

The 45-year-old Virginia driver overcome an early speeding penalty and drove from 31st through the field in a fairly dominating win for Joe Gibbs Racing and Toyota. He led a race-high 134 laps.

Hamlin was joined by his fiancee and their three children as he collected the checkered flag, and he was sure his father was smiling somewhere.

“This is a family sport. My family obviously had so much sacrifice to help me get here,” said Hamlin. “Now that I’ve grown, generations of Hamlins following me, it’s great Mom gets to see this. I know Dad’s still saying, ‘That’s my boy.’ Hell of a day.”

Team owner Joe Gibbs' praised Hamlin's resilience.

“He’s been through a lot. Denny seems to have the ability to continue to work through things,” said Gibbs. “Has a way of just really still being very competitive. I appreciate him so much. We’re riding Denny for about 20 years. It’s been an awful good trip for us.”

Toyota has won four of the first five races.

Hendrick Motorsports teammates Chase Elliott and William Byron finished second and third in Chevrolets; JGR drivers Christopher Bell and Ty Gibbs were fourth and fifth to give JGR three cars in the top-five.

"It makes my job really easy when I can drive Toyotas that fast,” Hamlin said.

It was the third consecutive top-five finish for Gibbs, who is a central figure in a federal lawsuit filed by JGR against former competition director Chris Gabehart. The two sides are back in court in North Carolina on Monday as JGR seeks a restraining order to stop Gabehart for working for rival Spire Motorsports.

“Just don't want to be in court,” said team owner Gibbs. “But we're going to be there. I think it's important for us to follow through with this.”

Gabehart has said his time at JGR became untenable in part because of preferential treatment toward Gibbs, who is the grandson of the team owner.

JGR alleges Gabehart stole proprietary information before he left the team, and had a non-compete clause that prevents him from joining another team. Gabehart claims JGR stopped paying him in November and the role he now has with Spire is completely different from what he did for Gibbs.

Gabehart was at the track Sunday with Spire, which at Las Vegas had its trucks parked next to the JGR trucks.

The Cup Series races Sunday at Darlington Raceway in South Carolina. Joe Gibbs Racing dominated at the track last year — Hamlin won in April and Chase Briscoe in August.

AP auto racing: https://apnews.com/hub/auto-racing