Philips Sonalleve Receives CE Mark for MR-guided Focused Ultrasound Ablation of Metastatic Bone Cancer


During last month’s meeting of the European Congress of Radiology in Vienna, Philips Healthcare announced that its Sonalleve MR-HIFU system has received CE Marking for palliative care of patients with bone metastases. Equivalent to FDA approval in the U.S., CE Marking is recognized by countries in the European Economic Area and signifies that a product complies with the essential requirements of relevant health, safety and environmental protection legislation.

The company acknowledged that it intends to seek similar approval in the U.S.

Philips has been marketing the Sonalleve for uterine fibroid treatment since December 2009 and has installed 22 systems worldwide. The Sonalleve system uses ultrasound energy to ablate metastatic tissue and sensitive nerves around the bone, alleviating the significant pain experienced by advanced cancer patients. The system’s MR imaging provides 3D planning and temperature monitoring.