Medical Device Regulatory Clearance & Approval Conference, September 12-13 2011, Balt
Providing Clarity & Definition to New & Existing FDA Regulatory Pathways to Ensure Medical Device Approvals in a Timely & Cost Efficient Manner There is no doubt that the medical device industry is currently...
Abbott (NYSE: ABT) today announced it has received U.S. Food and Drug Administration (FDA) approval for the RX Herculink Elite® Renal Stent System for the treatment of renal artery stenosis (narrowing of the main arteries supplying blood to the kidneys) in patients with uncontrolled hypertension...
Relievant Medsystems, Inc. announced the company has received Food and Drug Administration approval of an Investigational Device Exemption (IDE) to begin their SMART pivotal trial to evaluate the safety and effectiveness of the Intracept® System for treatment of chronic low back pain. The SMART...
Pharmalucence, Inc. has received FDA approval expanding the route of administration and use of its Sulfur Colloid Injection (SCI) to include location of lymph nodes in breast cancer patients. Sulfur Colloid Injection (SCI) is a radioactive tracer manufactured by Pharmalucence which labels lymph...
Boca Pharmacal, Inc., announced that it has received approval from the FDA of its Abbreviated New Drug Application (ANDA) for Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5mg / 325mg per 5mL, the generic version of Hycet® Oral Solution distributed by FSC Laboratories, Inc...
Nephros, Inc. (OTC Bulletin Board: NEPH), a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification, announced that the Company has received 510k clearance from the U.S. Food and Drug Administration to market...
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for expansion of its BROADEN™ (BROdmann Area 25 DEep brain Neurostimulation) study for depression. This expansion will allow a maximum of 20...
Medifocus Inc. (OTC:MDFZF.PK) and (TSXV:MFS) is pleased to announce that the Western Institutional Review Board (WIRB) has granted IRB approval to the Comprehensive Breast Center of Coral Springs Florida, a division of 21st Century Oncology to conduct Medifocus' Pivotal Phase III Breast Cancer...
Okay, so I'm 18 (and a half, if it matters) and I really want to go visit my best friend in Germany this summer. My dad is in the Air Force and we used to live abroad, so it would not be my first time traveling alone. I also speak German pretty well, but I could do with some work.
But anyway...
Okay, so I'm 18 (and a half, if it matters) and I really want to go visit my best friend in Germany this summer. My dad is in the Air Force and we used to live abroad, so it would not be my first time traveling alone. I also speak German pretty well, but I could do with some work.
But anyway...
Okay, so I'm 18 (and a half, if it matters) and I really want to go visit my best friend in Germany this summer. My dad is in the Air Force and we used to live abroad, so it would not be my first time traveling alone. I also speak German pretty well, but I could do with some work.
But anyway...
Okay, so I'm 18 (and a half, if it matters) and I really want to go visit my best friend in Germany this summer. My dad is in the Air Force and we used to live abroad, so it would not be my first time traveling alone. I also speak German pretty well, but I could do with some work.
But anyway...
Okay, so I'm 18 (and a half, if it matters) and I really want to go visit my best friend in Germany this summer. My dad is in the Air Force and we used to live abroad, so it would not be my first time traveling alone. I also speak German pretty well, but I could do with some work.
But anyway...
Novartis announced that the US Food and Drug Administration (FDA) approved Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure. Amturnide combines the only approved direct renin inhibitor worldwide, Tekturna (aliskiren), with the widely used...
Editorials have responded to FDA's announcement that it will revoke approval of the drug Avastin to treat metastatic breast cancer because of studies suggesting it does not extend women's lives and carries significant risks. Summaries appear below. ~ Los Angeles Times: FDA's ruling "drew howls...
Allergan, Inc. (NYSE: AGN) announced the U.S. Food and Drug Administration (FDA) Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee has recommended with an 8-2 vote that the FDA extend the currently approved use of the LAP-BAND® System, Allergan's gastric band...
Prism Pharmaceuticals, Inc. announced that the U.S. Food & Drug Administration (FDA) has approved the supplemental new drug application for NEXTERONE® (amiodarone HCl) Premixed Injection, the first and only premixed intravenous (IV) bag formulation of the antiarrhythmic agent amiodarone IV...
China Medical Technologies, Inc. (the "Company") (Nasdaq: CMED), a leading China-based advanced in-vitro diagnostic ("IVD") company, announced that it has received approval for its real-time PCR-based Epidermal Growth Factor Receptor ("EGFR") Assay (the "EGFR PCR Assay") for the use of lung...