Medical News Today -- Teleflex Medical, a leading global supplier of disposable products for critical care and surgical applications, has received clearance from the FDA to market the Hudson RCI Neb-U-Mask®, a respiratory device that allows for the concurrent delivery of aerosolized medication and a...

SHENZHEN, China, Sept. 25 /Xinhua-PRNewswire/ -- Winner Medical Group Inc. (OTC Bulletin Board: WMDG; "Winner Medical" or "the Company") announced that it has entered into an agreement with Shanghai Hongsong Company, under which Shanghai Hongsong Company will exclusively sell the...

ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ - News) today announced U.S. Food and Drug Administration (FDA) clearance of its SJM Confirm™ implantable cardiac monitor (ICM), a compact device designed to help physicians diagnose abnormal heart rhythms.

CQ -- A new report from the Advanced Medical Technology Association, or AdvaMed, aims to stress the safety and efficacy of the current Food and Drug Administration (FDA) process for approving medical devices to counter criticism of the process that could appear in an upcoming Government Accountabili...

BETHLEHEM, Pa.--(BUSINESS WIRE)--B. Braun Medical Inc. today announced it had received 510(k) clearance from the FDA for the industry’s first silver-impregnated antibacterial Luer Access Device (LAD) designed to reduce potential catheter-related bloodstream infections.

AP -- Government regulators have issued new rules designed to keep drug warning labels clear and concise, though some say the new guidelines would also shield drugmakers from lawsuits. The Food and Drug Administration regulations, which were released last week and take effect next month, explain whe...

DOTmed -- The Advanced Medical Technology Association (AdvaMed) has released a white paper explaining the history and evolution of FDA's premarket notification, or "510(k)," process for medical devices and diagnostics. Approximately 90 percent of the medical devices available in the U.S...

August 15, 2008, Jacksonville, FL: ENCO Analytix announces the U.S. Food and Drug Administration (FDA) completed a comprehensive inspection at the company’s facility in Jacksonville, FL on July 29-30, 2008. The inspection was related to the company’s registration with the FDA as an Analytical Labora...

Guidance for Industry - Medical Device Tracking; Guidance for Industry and FDA Staff.

Dublin, Ireland, August 11th, 2008 – ICON plc (NASDAQ: ICLR; ISIN:IE0005711209), a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that its Medical Imaging division has become the first commercial imaging core lab...