Profound Medical Receives FDA HDE ... | 合法醫療器材資訊網

2020年11月30日—Sonalleve®isaninnovativetherapeuticplatformthatcombinesreal-timeMagneticResonanceimagingandthermometrywiththermalultrasoundto ...

TORONTO, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”) announced today that Sonalleve® has received U.S. Food and Drug Administration (“FDA”) approval under a Humanitarian Device Exemption (“HDE”) for the treatment of osteoid osteoma. [1]

Osteoid osteoma is 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. An osteoid osteoma causes a dull, aching pain that is moderate in intensity, but can worsen and become severe, especially at night. Computed tomography(CT)-guided radiofrequency ablation (RFA), the most commonly used osteoid osteoma treatment, 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 he...