YOQNEAM, ISRAEL–(Marketwire – 03/10/11) – Given Imaging Ltd. (NASDAQ:GIVN – News), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced updated clearance from the U.S. Food and Drug Administration (FDA) for the PillCam SB video capsule, including clearance to promote its use in monitoring lesions that may indicate Crohn’s disease. [...]

MINNEAPOLIS–(BUSINESS WIRE)– Medtronic, Inc. (NYSE:MDT – News) today announced that the U.S. Food and Drug Administration (FDA) has informed the company that issues noted in two warning letters — one from November 2009 regarding the company’s Mounds View, Minnesota facility and another from June 2009 regarding the company’s manufacturing facility in Juncos, Puerto Rico — [...]

(Reuters) – Johnson & Johnson, which has been plagued by repeated recalls of its consumer medicines and medical devices over the past year, on Wednesday said it recalled 107 batches of surgical sutures in December due to potential sterility problems. The recall came to light on Wednesday after the United Kingdom Medicines and Healthcare products [...]

12/21/2010 MINNEAPOLIS–(BUSINESS WIRE)–An estimated 1.2 million people in the United States have an abdominal aortic aneurysm (AAA) – a dangerous bulge or ballooning in their bodies’ main artery1 that typically causes no symptoms until it ruptures, which can be deadly – and most of them don’t know it. But for those with a known AAA [...]

BRIDGEWATER, N.J., Dec. 8, 2010 /PRNewswire/ –Valeritas, Inc., a medical technology company committed to the development and commercialization of innovative drug delivery solutions, announced today that the US Food and Drug Administration has cleared the company’s V-Go Disposable Insulin Delivery Device for the continuous subcutaneous delivery of insulin in preset basal rates and with on-demand bolus dosing [...]

If you watch television or read the newspapers, you know that practically every personal injury lawyer in the U.S. has been fishing for potential clients to sue DePuy over its recalled ASR XL Acetabular hip replacement system. The product was recalled in August 2010. Numerous lawsuits have been filed throughout various jurisdictions throughout the U.S. [...]

ISSUE: WalkMed Infusion LLC notified healthcare professionals of a nationwide recall of the Triton Pole Mount Infusion Pump, serial numbers 001 through 500 and serial numbers TR1401 through TR 2559, manufactured and sold before June 2010. If the pump door is not closed and latched per the instructions for use located on the side of [...]

Hospira Symbiq One and Two Channel Infuser Recall Class: I Date Recall Initiated: February 22, 2010 Products: Symbiq Infusion System Brand Name: Symbiq One-Channel Infuser Symbiq Two-Channel Infuser Model Numbers: 16026 Symbiq One-Channel Infuser 16027 Symbiq Two-Channel Infuser The affected units were distributed from December 23, 2006 to January 22, 2010. All lots are affected [...]

MINNEAPOLIS–(BUSINESS WIRE)–Medtronic, Inc. (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) has classified the company’s previous action related to the Octopus Nuvo Tissue Stabilizer as a Class I recall. FDA classifies a recall as Class I when the agency believes that there is a reasonable probability that use of the recalled product [...]

Latest innovation in plastic biliary stent technology includes features for enhanced deliverability, efficiency and procedural control PR Newswire NATICK, Mass., Oct. 21 NATICK, Mass., Oct. 21 /PRNewswire-FirstCall/ — Boston Scientific Corporation (NYSE: BSX) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration and CE Mark approval to market its Advanix Biliary [...]