Scottsdale, Ariz. — Dutch medical device company Medical Precision Inc. has entered the U.S. market with its Comfort Marker, an FDA De Novo-cleared device designed to reduce pain and discomfort when placing reference marks on radiotherapy patients.
The company plans to introduce the device to U.S. clinicians at the American Society for Radiation Oncology Annual Meeting, being held Sept. 26-30 in Boston.
Reference points, often called radiotherapy tattoos, are used to help clinicians align patients consistently during treatment. Traditional methods typically use hand-held lancets that puncture the skin to a depth of about 2 to 3 millimeters.
Medical Precision said the Comfort Marker uses technology adapted from the permanent make-up industry to deliver pigment at a shallower depth of 0.2 to 0.7 millimeters.
The device includes a disposable safety needle module with color-coded depth settings designed to help clinicians place marks consistently while reducing the risk of needle-stick injuries. The company said the marks can also be removed with a laser session after treatment is completed.
According to Medical Precision, the device is designed to provide a gentler marking process, simple operation and portability through a battery-powered control unit that can be used in CT or treatment rooms.
“We focus on improving the patient journey,” Chief Commercial Officer Jeroen van den Oever said. “Radiotherapy can already be a stressful experience, and the marking process shouldn’t add to that stress. With the Comfort Marker, we’re able to give patients a noticeably more comfortable start to treatment, while giving clinical teams a device that is fast, safe, and easy to build into their existing workflow.”
“Bringing that experience to patients and providers in the United States has been a goal of ours for some time, and we’re excited to share it with the community at ASTRO,” he added.
The Comfort Marker is FDA De Novo cleared and CE marked. Medical Precision is ISO 13485 certified.
U.S. radiation oncology teams will be able to see the Comfort Marker at booth 2157 during the 2026 ASTRO Annual Meeting in Boston. The company said additional ordering and availability details for the U.S. market will be announced ahead of the event.
