June 18 A new Food and Drug Administration- approved system developed in partnership with an Army command at Fort Detrick better preserves the quality of collected red blood cells while extending the product's shelf life, potentially saving the Pentagon millions of dollars annually. Called SOLX (r) System, the product received approval from the F
ALBANY, N.Y., June 18, 2013 AngioDynamics, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced the U.S. Food& Drug Administration has granted Investigational Device Exemption approval to conduct a clinical study of the NanoKnife System for the ablat
By a News Reporter-Staff News Editor at Pharma Business Week Blue Belt Technologies, Inc., an innovative medical technology company commercializing robotic-assisted solutions for orthopedic surgery, announced that it has received 510 clearance from the U.S. Food and Drug Administration to market its STRIDE? Unicondylar Knee implant system.
The U.S. Food and Drug Administration today approved the MemoryShape Breast Implant to increase breast size for use in women at least 22 years old and to rebuild breast tissue in women of any age. The FDA's approval is based on six years of data from 955 women demonstrating that there is a reasonable assurance of safety and effectiveness for this i
In partnership with the U.S. Army Medical Materiel Development Activity, Hemerus Medical LLC received U.S. Food and Drug Administration approval of the New Drug Application for its SOLX System April 25. This system has been approved in the United States by the FDA for six weeks red blood cell storage and was previously approved in Europe for eight
FDA Grants Priority Review to Bristol-Myers Squibb and AstraZeneca's Metreleptin, an Investigational Agent for Treatment of Metabolic Disorders Associated with Rare Forms of Lipodystrophy. By a News Reporter-Staff News Editor at Diabetes Week Bristol-Myers Squibb Company and AstraZeneca announced that the U.S. Food and Drug Administration has...
By a News Reporter-Staff News Editor at Pharma Business Week Celgene Corporation announced the U.S. Food and Drug Administration has approved the company's supplemental new drug application for REVLIMID for the treatment of patients with mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which inclu
Washington, D.C., June 14- Senator Lamar Alexander today praised the signing into law of legislation that he said would "reduce farmers' costs by reducing the average waiting time for the FDA to approve generic animal drugs by 450 days and eliminating a backlog of applications." Alexander, the Ranking Republican on the Senate health committee, said
Senator Lamar Alexander today praised the signing into law of legislation that he said would "reduce farmers' costs by reducing the average waiting time for the FDA to approve generic animal drugs by 450 days and eliminating a backlog of applications." Alexander, the Ranking Republican on the Senate health committee, said of the Animal Drug User Fe
By a News Reporter-Staff News Editor at Health& Medicine Week Breathe Technologies, Inc., a manufacturer of innovative medical devices for people with respiratory conditions announced the Food and Drug Administration has granted the company 510 clearance to market its Sleep System in the US for treatment of Obstructive Sleep Apnea. The Breathe Sl
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release: The U.S. Food and Drug Administration today approved the MemoryShape Breast Implant to increase breast size for use in women at least 22 years old and to rebuild breast tissue in women of any age. The MemoryShape Breast Implants are man
June 13 The Food and Drug Administration on Thursday expanded the approved use of Amgen Inc.' s Xgeva for treating giant cell tumor of the bone. Amgen is now clear to offer Xgeva as a treatment for giant cell tumor of the bone, or GCTB, a rare and typically noncancerous tumor. "Advances in our understanding of the underlying biology of this rare
The company's MemoryShape breast implant uses a cross-linking gel design that the FDA says is firmer than previous implants. FDA regulators approved the new implant for breast enhancement and reconstruction in women at least 22 years old. The FDA banned sales of silicone breast implants in 1992, saying manufacturers had not provided enough medical
Mary Green, M.D., PhD of Eye Excellence, a Cataract and LASIK practice located in Houston Texas, now has a new a new tool in her arsenal for taking care of cataracts, and mild to moderate open-angle glaucoma at the same time: the iStent Trabecular Micro-Bypass. Having received FDA approval, the iStent is not only the only implant approved for
Mentor Worldwide LLC, the U.S. market leader in breast aesthetics, today announced the U.S. Food and Drug Administration has approved MENTOR MemoryShape? Breast Implants, providing new options for women looking for a more natural shape and youthful feel from breast enhancement or reconstruction surgery. "We understand each woman has different
St. Jude Medical, Inc., a global medical device company, announced U.S. Food and Drug Administration approval of its next-generation Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators. Anne B. Curtis, Chairman of the Department of Medicine with the University at Buffalo.
June 13 The U.S. Food and Drug Administration on Thursday expanded the approved use of Amgen Inc.' s Xgeva for treating giant cell tumor of the bone. Amgen is now clear to offer patients a new tool in their fight against giant cell tumor of the bone, a rare and typically noncancerous tumor. "Advances in our understanding of the underlying biolog
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. The U.S. Food and Drug Administration today expanded the approved use of Xgeva to treat adults and some adolescents with giant cell tumor of the bone, a rare and usually non-cancerous tumor. "Today's approval of Xgeva provides a neede
Teleflex Inc., a provider of medical deices for critical care and surgery, has announced it has received FDA 510 clearance to market its Arrow NextStep Retrograde Femoral Length Dialysis Catheters. "Providing clinicians with the Arrow NextStep Femoral Length Catheters continues a series of new product introductions that demonstrates our commitment
Cordis Corporation today announced it has received clearance from the Food and Drug Administration of its latest innovation in guiding catheters: the ADROIT TM 6 F Guiding Catheter. The new ADROIT TM Guiding Catheter, allows physicians to have more options for treating a wide range of challenging cases. These features enhance treatment options f
Release date- 11062013- Swedish Orphan Biovitrum AB today announced receipt of approval from the Food and Drug Administration for the manufacture of drug substance for Kineret at Boehringer Ingelheim's microbial site in Vienna, Austria. 'We are very pleased that the FDA has approved our technology transfer of Kineret manufacturing from Amgen to Boe
WASHINGTON Shares of St. Jude Medical moved higher Wednesday after regulators unexpectedly approved two new heart devices from the company, despite ongoing safety issues at the company's plant in California. The Ellipse is an implantable defibrillator, while the Assura combines a pacemaker and a defibrillator. In November the FDA released an ins
Today at the Society of Nuclear Medicine and Molecular Imaging meeting, GE Healthcare announced that it has received FDA clearance of its latest Xeleris Processing and Review workstation software, adding to one of the most innovative suites of Molecular Imaging solutions in the industry. The latest release of Xeleris enables automation, personaliza
St. Jude Medical, Inc., a global medical device company, today announced U.S. Food and Drug Administration approval of its next-generation Ellipse? and SJM Assura? portfolio of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators. Anne B. Curtis, Chairman of the Department of Medicine with the University
