Medical Devices Could Face Cyber Threats, Warns FDA
Michael Harper for redOrbit.com – Your Universe Online The conversation of cyber security has largely focused on the issue of protecting national security and the private sector. Without proper preventive measures in place, hackers, spies and...
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The DrugRisk Resource Center is the Web’s largest source for information on prescription drug research, side effects and legal news. Visit http://www.DrugRisk.com New York, NY (PRWEB) June 19, 2013 The birth control safety advocates at DrugRisk.com are announcing new information on the site for women using the IUD contraceptive Mirena. A new report shows the FDA has received over 70,000 reports of Mirena side effects, many involving serious injury or requiring surgery*. DrugRisk was...
McGuff Pharmaceuticals, Inc. (MPI) continues to pursue the approval of an Abbreviated New Drug Application (ANDA) for Hydroxyprogesterone Caproate Injection, USP 250mg/mL, 5mL, multiple dose vial; a generic version of Bristol-Myers Squibb’s drug formerly known as Delalutin™. While McGuff Pharmaceuticals can not predict when the FDA will complete its review, MPI remains committed to bringing the drug product to market as quickly as possible. Santa Ana, CA (PRWEB) June 19, 2013 McGuff...
Delivering Diagnostic Confidence in Cardiac Disease Management BREA, Calif., June 19, 2013 /PRNewswire/ -- Continuing its long history of proven clinical performance in diagnosis of myocardial infarction (MI), Beckman Coulter, Inc. announces the U.S. Food and Drug Administration (FDA) 510(k) clearance of its new Access AccuTnI+3 troponin I assay for use on its Access 2 immunoassay system. "Clinicians have depended on Beckman Coulter's troponin I test for over 12 years and the new...
MUMBAI, India, June 19, 2013 /PRNewswire/ -- Bharat Book Bureau has recently added DrugPatentWatch to its extensive list of Online Databases. (http://www.bharatbook.com/drugpatentwatch-tour.pdf) (Logo: http://photos.prnewswire.com/prnh/20130128/590935 ) DrugPatentWatch provides comprehensive information on pharmaceutical, drug patents and their expirations. This value-added information supports the critical business functions of patent agents and attorneys,...
ATLANTA, June 19, 2013 /PRNewswire/ -- CryoLife, Inc. (NYSE: CRY), a leading tissue processing and medical device Company focused on cardiac and vascular surgery, announced today that it has received conditional approval of its Investigational Device Exemption (IDE) for PerClot from the United States Food and Drug Administration (FDA). PerClot is a unique hemostat composed of absorbable polysaccharide granules and is intended for use in surgical procedures as an adjunctive hemostatic...
PARSIPPANY, N.J., June 19, 2013 /PRNewswire/ -- Actavis, Inc. (NYSE: ACT) and Kissei Pharmaceutical Co., LTD today confirmed that they have filed lawsuits against Sandoz Inc., Hetero USA, Inc., Hetero Labs Limited and Hetero Labs Limited, Unit III in the U.S. District Court for the District of Delaware for infringement of U.S. Patent No. 5,387,603 (the '603 patent) covering Rapaflo(®), a treatment for the signs and symptoms of benign prostatic hyperplasia (BPH). Actavis and Kissei's...
Nathalie Chevreau of Tatalou Science announces summer buy-one-get-one-free deal on Brain Clarity and Bene-Fiit products in a new blog post on Tatalou Science’s website. Salt Lake City, Utah (PRWEB) June 18, 2013 Registered Dietitian Nathalie Chevreau, PhD, R.D., announced today on her blog that her company, Tatalou Science, has launched a summer deal offering buy-one-get-one-free on Tatalou’s natural health supplements. The details of the deal and the coupon code were published to the...
DrugRisk is the Web’s largest source for information on prescription drug warnings, side effects and legal news. Visit http://www.DrugRisk.com Los Angeles, CA (PRWEB) June 18, 2013 The diabetes drug safety center at DrugRisk.com is announcing updated information for patients taking the medication Byetta. The FDA met with drug makers last week to decide additional safety studies of the drug after reports linking it to pancreatic cancer*. The goal of DrugRisk is to improve the safety of...
Advanced Device Prototypes on the Way Along with FDA 510k and PMA Applications. Irvine, CA (PRWEB) June 18, 2013 EP Global Communications, Inc. (the Company), (Stock Ticker: EPGL) EPGL Medical Sciences, is pleased to announce several new devices resulting from the TopSpin technology recently announced. Many of these devices have not been revealed before today. To Compliment the MPDD, the new MPTT will be first to become a prototype this fall and new FDA 510k and PMA Applications are...
Researchers offer new framework to improve the safety and effectiveness of surgical procedures and implantable devices An international team of investigators co-led by Weill Cornell Medical College is offering a new framework for evidence-based surgery and device research, similar to the kind of risk and benefit analysis used in evidence-based medicine. "Currently, there is no dynamic research framework to systematically detect devices and surgeries that don't offer any benefits to...
Latest Food and Drug Administration Reference Libraries
The Chilean sea bass is the North American name for the Patagonian toothfish. The Chilean sea bass name derived in 1977 from Lee Lantz, a fish wholesaler looking for a more attractive name for the American fish market. In 1994 the Food and Drug Administration (FDA) accepted the Chilean sea bass as an alternative name for the Patagonian toothfish. This species is native to the southern Pacific, Atlantic, and Indian Oceans, around seamounts and continental shelves in the colder waters. The...
