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# Profound Medical HDE OK’d for Osteoid Osteomas
- URL: https://www.fdaweb.com/profound-medical-hde-okd-for-osteoid-osteomas/
- Published: 2020-11-30T12:00:00.000Z
- Updated: 2026-09-14T16:38:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148185

FDA has approved a Profound Medical humanitarian device exemption to market Sonalleve for treating osteoid osteoma, a non-cancerous bone tumor that occurs most often in the long bones of the leg, such as the femur and tibia, of young children and adolescents. The condition causes a dull, aching pain that is moderate in intensity, but can worsen and become severe, especially at night, the company says.

Sonalleve was developed as an alternative to current computed tomography-guided radiofrequency ablation (RFA), the most commonly used osteoid osteoma treatment that requires drilling through muscle and soft tissue into bone, and also exposes the patient to radiation from the imaging necessary to guide the probe that is inserted to heat and destroy tumor tissue, Profound Medical says. Sonalleve’s therapeutic platform combines real-time magnetic resonance imaging and thermometry with thermal ultrasound to enable precise and incision-free ablation of diseased tissue, it says.