Medical Precision Gets De Novo Clearance for Its Radiological Marker

Medical Precision has received the FDA’s de novo clearance for its Comfort Marker 2.0, intended for use in radiation therapy.

The device is for use in clinical settings by radiotherapy professionals and is indicated for applying ink to the patients’ skin to identify the margins for radiation therapy.

The FDA has classified the marker as a Class II device that requires special controls to provide “reasonable assurance of the safety and effectiveness.”