We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Manufacturers and assemblers of X-ray computed tomography (CT) equipment may use an alternate measure of the computed tomography dose index (CTDI) when scanning patients, a new FDA guidance says.
The FDA's Clinical Chemistry and Clinical Toxicology Devices Panel met Dec. 6 to hear recommendations regarding the validity of lipid subfraction diagnostic assays to show patients' risk of cardiovascular disease (CVD).
The U.S. and Japan want to remove barriers to timely medical device approvals through the "Harmonization by Doing" (HBD) initiative, aimed at developing common protocols for premarket clinical studies of new cardiovascular technologies.
PharmaMedDevice, a forum representing the convergence of the device, pharmaceutical and biologic industries, will hold its inaugural event alongside the Interphex conference April 2426, 2007, in New York.
The Immunology Devices Panel of the FDA's Medical Devices Advisory Committee Nov. 16 recommended approval with conditions for the Veridex GeneSearch lymph node assay by a vote of 9-1.
Bausch & Lomb's MoistureLoc contact lens solution was cited as "adulterated" in a recent FDA warning letter, which followed an agency inspection that found the firm did not conform to good manufacturing practice requirements.
A recent study shows that angioplasty with the use of stents -- also known as percutaneous coronary intervention (PCI) -- may offer no significant benefit compared with standard drug therapy in treating heart-attack patients.
A new study has found that a noninvasive, computer-based test is at least as effective as an invasive and more expensive test in predicting a patient's risk of sudden cardiac death.