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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

US launch

Medical Precision enters the US with a radiotherapy marker that got its own FDA product code

MedDevice Startups Staff · 2 days ago · 2 min read · Via Business Wire

Medical Precision opened US sales of the Comfort Marker on September 21. The Dutch company makes a powered device that places the permanent reference points radiotherapy teams line patients up with.

The device injects pigment 0.2mm to 0.7mm into the skin. A hand held lancet goes 2mm to 3mm. It uses color coded safety needles, and the marks can be removed by laser after treatment ends.

FDA granted the Comfort Marker 2.0 a De Novo under DEN200041, filed by Medical Precision B.V. of Zwolle. That created product code QRN and the Class II regulation 21 CFR 892.5785, covering powered devices that deliver colorant transdermally. The device also carries a CE mark.

US operations run from Scottsdale, Arizona, and the company will show the device at ASTRO in Boston from September 26 to 30, booth 2157. The De Novo is the real asset here: any competitor now files a 510(k) against Comfort Marker as the predicate.

Questions & Answers

What is the Medical Precision Comfort Marker?

It is a powered device that places permanent skin reference points on radiotherapy patients. Medical Precision delivers pigment 0.2mm to 0.7mm deep, shallower than the 2mm to 3mm reached by a hand held lancet.

Does the Comfort Marker have FDA authorization?

Yes. FDA granted Medical Precision B.V. a De Novo under DEN200041, which created product code QRN and the Class II regulation 21 CFR 892.5785.

Where is Medical Precision based?

Medical Precision runs European operations from Zwolle in the Netherlands and US operations from Scottsdale, Arizona. It opened US sales on September 21, 2026.

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