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TomoTherapy Incorporated announced that the University Clinic Heidelberg became the first German institution to treat cancer patients with the TomoTherapy(R) Hi-Art System(R).
The FDA Aug. 3 posted a guidance issued Aug. 1 on small business qualification and certification under the Medical Device User Fee and Modernization Act (MDUFMA).
The American College of Radiology (ACR) said Aug. 4 it strongly supports S. 3795, the Access to Medicare Imaging Act, which calls for a two-year moratorium on medical imaging reimbursement cuts included in the Deficit Reduction Act of 2005 (DRA).
Researchers at the FDA's National Center for Toxicological Research are developing a new way to screen for and identify bioterror agents and other substances used in hoax incidents, the agency announced Aug. 3.
In a July 10 warning letter, the FDA told the maker of a dry mouth reliever that its product is considered a saliva substitute, and therefore should be regulated as a medical device.
Northstar Neuroscience, Inc., a developer of medical devices for the treatment of neurological diseases and disorders, announced that the U. S. Food and Drug Administration (FDA) has granted approval for the company to conduct a clinical feasibility study of its cortical stimulation therapy system for the treatment of depression.
Patients diagnosed with prostate cancer often undergo either a radical prostatectomy, complete removal of the prostate gland, or radiation treatment over large portions of the prostate to combat the cancer.
Spectral Diagnostics Inc. announced an agreement with JUSTE S.A.Q.F. ("JUSTE"), a leading supplier of in-vitro diagnostic technologies, medical devices, and pharmaceuticals in Spain, to sell and distribute Spectral's EAA Endotoxin Activity Assay.