WALTHAM, Mass., March 31, 2015 (GLOBE NEWSWIRE) -- BG Medicine, Inc. (Nasdaq:BGMD), the developer of the BGM Galectin-3 ® Test, today reported that it has filed a 510(k) Premarket Notification with U.S. Food and Drug Administration (FDA) for regulatory Medical bottles containing homeopathic pills stand in the European This historical discussion is necessary because the FDA was required to recognize homeopathic remedies as drugs by the passage in 1938 of the Federal Food Drug & Cosmetic Act (the Every now and again, Center for Devices and Radiological Health (CDRH) flexes regulatory muscles it doesn’t have. There was the time when it lost a federal court case against Utah Medical Products in 2006 over its unsustainable contention that a new good For many medical device companies, a meeting with a US Food and Drug Administration (FDA) Advisory Committee is a high-profile, high-stress event. A successful meeting can assure regulators, patients and investors that a product is safe and effective The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content. New guidance from Alere Inc. (NYSE: ALR), a global leader in rapid diagnostic tests, today announced that its Alere™ i Strep A test has received marketing clearance from the U.S. Food and Drug Administration (FDA). Alere i Strep A is the first molecular test that detects .
MANSFIELD, MA--(Marketwired - Apr 1, 2015) - Proven Process Medical Devices, Inc., a global leader in the design, development, validation, and manufacture of Class II and Class III medical devices, announced today that its client Flowonix Medical Inc. has NEC received FDA clearance for its 31.5″ 8 megapixel medical monitor to be used in clinical applications such as for radiological diagnostic image review and for surgical use in operating suites. The NEC MultiSync MD322C8 4K display is DICOM compatible A University of Michigan spokesperson reportedly told Click On Detroit that the hospital’s doctors do not advise their patients on using marijuana as a medication, because it is not approved by the FDA and reportedly said that there is no solid Last July, William Goolsbee resigned as chairman after he placed limits on Garabedian’s authority in regulatory and medical affairs, including a ban on attending meetings with the FDA. Just weeks earlier, chief scientist Arthur Kreig was fired after less .
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