FDA OKs limited access to Profound Medical's Sonalleve device for bone tumor

 

• The FDA has signed off on a Humanitarian Device Exemption (HDE) for Profound Medical's (PROF +5.4%) Sonalleve system for the treatment of osteoid osteoma, a benign bone tumor that occurs in children and young adults.
• HDE, aimed at facilitating the development of medical devices for rare diseases affecting pediatric patients, allows for the sale of a certain number of devices at a profit prior to full approval. In this case, the ceiling, called the annual distribution number, is 8,000 units.
• https://seekingalpha.com/news/3640010-fda-oks-limited-access-to-profound-medicals-sonalleve-device-for-type-of-bone-tumor