FDA granted de novo clearance to SonaCare Medical LLC to market the Sonablate 450 in the U.S. for the ablation of prostate tissue.
Sonablate is the first High Intensity Therapeutic Ultrasound device to receive FDA regulatory authorization for prostate tissue ablation. SonaCare expects to begin U.S. distribution this October.
Sonablate is the Company’s second medical device to receive U.S. FDA regulatory authorization, complementing the 510(k) cleared Sonatherm laparoscopic HITU ablation device.
By law, the Food and Drug Administration is required to determine whether a drug, device, biologic, or medical device is “safe and effective.” But the FDA determination does not control whether the Centers for Medicare & Medicaid Services will pay for it. To satisfy CMS, medical products and services must be “reasonable and necessary,” meaning...
As a radiation oncologist, I am struck by how often the decisive variable in lung cancer is not the sophistication of our therapy, but the timing of our encounter with the disease. The American Cancer Society projects 618,120 cancer deaths in the United States in 2025, with lung cancer remaining as the single largest contributor,...
