FDA Alerts
FDA Approves Blood Pump System
The U.S. Food and Drug Administration today approved the Impella 2.5 System, a miniature blood pump system intended to help certain patients maintain stable heart function and circulation during certain high-risk percutaneous coronary intervention (HRPCI) procedures.
FDA Clears System to Reduce Stroke Risk during Stent and Angioplasty Procedures
The U.S. Food and Drug Administration today cleared for marketing the ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS), for use during a minimally invasive procedure to restore normal blood flow to narrowed carotid arteries.
FDA Approves Anti-Clotting Drug Savaysa
The U.S. Food and Drug Administration today approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
FDA Clears Test That Helps Predict Heart Disease Risk
The U.S. Food and Drug Administration today cleared a new screening test that predicts a patient’s risk of future coronary heart disease (CHD) events, such as heart attacks.
FDA Warns Consumers Not to Buy Weight Loss Product
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Super Extreme Accelerator, a product promoted and sold for weight loss on various websites, and possibly in some retail stores.
FDA Notifies Public of Hidden Ingredient in V26 Slimming Coffee
The Food and Drug Administration (FDA) is advising consumers not to purchase or use V26 Slimming Coffee, a product promoted and sold for weight loss on various websites and possibly in some retail stores.
FDA: Sit and Slim II Contains Hidden Drug Ingredients
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Sit and Slim II, a product promoted and sold for weight loss on various websites and possibly in some retail stores.
FDA Approves New Device to Open Blocked Arteries
The U.S. Food and Drug Administration today approved the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB).
FDA Approves New Use of Glucose Monitoring System for Hospitals
Today the U.S. Food and Drug Administration cleared a new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized.
Rx for Rare Genetic Disorder Now Approved for Patients of All Ages
The U.S. Food and Drug Administration today announced the approval of Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are less than 8 years of age.