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

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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.

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UV Smart's UV-C light

UV Smart D60 with TEE probes

UV Smart D60

Founder UV Smart

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UV Smart's UV-C light

UV Smart D60 with TEE probes

UV Smart D60

Founder UV Smart

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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

Blue Jays' Dylan Cease has bid for his 2nd career no-hitter broken up by Giants in 9th inning

SAN FRANCISCO (AP) — Dylan Cease knew he had a no-hitter going and was willing to throw an unusual number of pitches to finish it off.

Toronto Blue Jays manager John Schneider was happy to let him try.

“Dylan came in after the sixth (inning) and said, ‘I’ve got 120.’ I said, ‘OK.’ And then after the seventh, he said, ‘I’ve got 130,’” Schneider said.

Cease carried his bid for a second career no-hitter into the ninth inning Wednesday against the Giants before Heliot Ramos broke it up with a line-drive single to center field.

Cease was lifted after Ramos’ hit and got a standing ovation from the San Francisco crowd. Tyler Rogers came on and got the last three outs on four pitches as the Blue Jays won 10-0.

The 30-year-old Cease threw a career-high 118 pitches, 81 for strikes, as he sought the first solo no-hitter in the majors since 2024. The All-Star right-hander struck out 11 to increase his American League-leading total to 148.

“I kept saying, ‘Whatever it takes,’” Cease said. “I guess in my mind I thought maybe 130 at that point was what it was looking like.”

Schneider said he left Cease in the game because of his career durability and because he can get extra rest during next week's All-Star break.

“I’m a fan of baseball,” Schneider said. “I think if a guy has a chance to throw a no-hitter, I think you let him do it and I think you make adjustments after that.

“If I can let a player have that opportunity, I’m going to do it every single time. Maybe not every single time, but as long as I’m allowed to.”

Cease threw a no-hitter for the San Diego Padres at Washington on July 25, 2024. He thought he was in better form Wednesday than he was that day against the Nationals.

“I was really commanding the ball well, mixing the ball well,” Cease said. “I’m just happy it wasn’t Luis (Arraez) that broke it up again.”

While pitching for the Chicago White Sox, Cease lost a no-hit bid on Sept. 3, 2022, with two outs in the ninth inning when Arraez singled for Minnesota. Arraez, now San Francisco’s second baseman and a winner of three batting titles, was the hitter after Ramos.

Eight days after Cease's no-hitter two years ago, Blake Snell threw one for the Giants at Cincinnati.

Since then, there have been two combined no-hitters — including one in March by Tatsuya Imai, Steven Okert and Alimber Santa of the Houston Astros — but no one has done it on his own as managers more frequently pull pitchers in the middle of hitless outings because of concerns over pitch counts and injuries.

Cease had plenty of velocity in the ninth, throwing two 97 mph fastballs to Ramos before giving up the hit on a 96 mph sinker.

“I’m thinking he’s probably going to be looking for a slider at some point,” Cease said. “I figured if I go a couple of heaters and a sinker in, it would surprise him.

“I wish I got it a little more in, but a good batter got a hit. It’s baseball.”

The Blue Jays have gone nearly 36 years without a no-hitter. Dave Stieb threw one on Sept. 2, 1990.

Including playoffs, 35 big league pitchers have thrown multiple no-hitters. Mike Fiers of the Athletics became the last to do it on May 7, 2019.

Cease set down the first 14 San Francisco batters before he walked Willy Adames with two outs in the fifth. Cease also walked Drew Gilbert leading off the sixth and Rafael Devers with one out in the seventh.

Toronto’s defense made two solid plays to sustain the no-hit bid. With two outs in the seventh, Adames sent with a grounder up the middle, and second baseman Ernie Clement ranged to the left side of the bag and made a nice pickup and throw to first.

Leading off the eighth, Bryce Eldridge hit a drive to deep left-center. Center fielder Daulton Varsho raced to make an excellent catch before running into the wall.

Cease then struck out Gilbert and pinch-hitter Drew Cavanaugh.

“When Daulton made that play,” Cease said, “it was like, ‘Man, that’s what happens in no-hitters.’ At that point, I really did it have it on my mind and I thought, ‘All right, we’ve got a shot today.’”

Ramos said Cease “had it going on today. I think we should have done a better job attacking the zone, just being aggressive, but at the end of the day, he’s a really good pitcher.

“I think he’s Cy Young-caliber.”

AP MLB: https://apnews.com/hub/mlb