FDA approved several devices from Elecsys® on April 29, 2010, including:
Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV on the MODULAR ANALYTICS E170 Immunoassay Analyzer - P090009
Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV on the cobas e 601 Immunoassay Analyzer - P090008
Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV on the cobas e 411 Immunoassay Analyzer - P090007
These and other devices can be found on FDA's Website
Tuesday, January 25, 2011
Monday, January 24, 2011
FDA Approves Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults
The U.S. Food and Drug Administration today approved Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults.
Major depressive disorder, also called major depression, is characterized by symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of major depression often recur throughout a person's lifetime, although some may experience only a single occurrence.
Signs and symptoms of major depression include: depressed mood, loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide. All people with major depression do not experience the same symptoms.
“Major depressive disorder is disabling and prevents a person from functioning normally,” said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression.”
The most frequent adverse reactions reported by patients taking Viibryd in clinical trials included diarrhea, nausea, vomiting, and insomnia.
The drug will be available in 10, 20 and 40 milligram tablets.
Viibryd and all other antidepressant drugs have a boxed warning and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults ages 18 to 24 during initial treatment.
The warning also says data did not show this increased risk in adults older than 24 and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior. The warning says depression and other serious psychiatric disorders themselves are the most important causes of suicide and that close monitoring of patients starting these medications is necessary.
Viibryd is manufactured by PGxHealth, New Haven, Conn.
Major depressive disorder, also called major depression, is characterized by symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of major depression often recur throughout a person's lifetime, although some may experience only a single occurrence.
Signs and symptoms of major depression include: depressed mood, loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide. All people with major depression do not experience the same symptoms.
“Major depressive disorder is disabling and prevents a person from functioning normally,” said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression.”
The most frequent adverse reactions reported by patients taking Viibryd in clinical trials included diarrhea, nausea, vomiting, and insomnia.
The drug will be available in 10, 20 and 40 milligram tablets.
Viibryd and all other antidepressant drugs have a boxed warning and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults ages 18 to 24 during initial treatment.
The warning also says data did not show this increased risk in adults older than 24 and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior. The warning says depression and other serious psychiatric disorders themselves are the most important causes of suicide and that close monitoring of patients starting these medications is necessary.
Viibryd is manufactured by PGxHealth, New Haven, Conn.
Tuesday, January 18, 2011
FDA Approves Head Lice Treatment for Children and Adults
The U.S. Food and Drug Administration today approved Natroba (spinosad) Topical Suspension 0.9% for the treatment of head lice infestation in patients ages 4 years and older.
Head lice are parasitic insects found on people’s head, eyebrows, and eyelashes. They feed on human blood several times a day but are not known to cause disease. Head lice are spread mainly by direct head-to-head contact with a person who already has head lice. Lice move by crawling and can easily travel from child to child because children play closely together and often in large groups.
“Natroba provides another option for the topical treatment of head lice infestations, which are especially prevalent in the pediatric population,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “Head lice is a common problem among school children in the United States.”
Head lice are parasitic insects found on people’s head, eyebrows, and eyelashes. They feed on human blood several times a day but are not known to cause disease. Head lice are spread mainly by direct head-to-head contact with a person who already has head lice. Lice move by crawling and can easily travel from child to child because children play closely together and often in large groups.
“Natroba provides another option for the topical treatment of head lice infestations, which are especially prevalent in the pediatric population,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “Head lice is a common problem among school children in the United States.”
Brazil, China, and India Expected to Take On the US In Medical Device Innovation
In a 52 page report to be released today PwC has indicated that the US's domination of medical device innovation is slipping. In part because of the emerging presence of Brazil, China, and India.
The report indicates that Brazil, China, and India will most likely overtake the US as the leading innovators of medical supplies into the next decade. Research and capital will most likely go to these nations - which usually provided US firms with grants to conduct their innovative research.
Good paying jobs and supporting infrastructure capital products will likely flow with the migration of medical device innovation.
Currently the United States leads the medical device innovative landscape followed by China and then India. However, the main pillars of success in this field is quickly dissolving. The contributing areas include:
The report indicates that Brazil, China, and India will most likely overtake the US as the leading innovators of medical supplies into the next decade. Research and capital will most likely go to these nations - which usually provided US firms with grants to conduct their innovative research.
Good paying jobs and supporting infrastructure capital products will likely flow with the migration of medical device innovation.
Currently the United States leads the medical device innovative landscape followed by China and then India. However, the main pillars of success in this field is quickly dissolving. The contributing areas include:
- University Involvement in cutting edge research
- A supportive regulatory process
- Patients requesting the latest treatments
- Investment partners
Antibody Test - OraQuick HCV Rapid Antibody Test - P080027
This medical device was FDA approved on June 25, 2010. The medical device is used to detect hepatitis C virus (HCV). It works by detecting if a patient has been exposed to the hepatitis C virus. If this is the case the body elicits an immune response and produces antibodies to fight off the virus. The test allows clinicians to determine if the antibodies are present in the blood.
The medical device works by attaching themselves to the antibodies – a chemical reaction causes the test strip to change color indicating the presence.
False positives should be verified with other tests to rule out error.
Ophthalmic - Implantable Miniature Telescope™ - P050034
This medical device was FDA approved on July 1st, 2010. It is an implantable miniature telescope that is used to treat patients with age-related macular degeneration (AMD).
Macular Degeneration is a disease that affects adults over the age of 60 and is the leading cause of vision loss.
It is denoted by a loss of “central vision” which is critical for doing such tasks as reading or driving. The macula is the region of the eye that helps with seeing fine detail when it begins to become affected vision loss can occur. Sometimes it happens slowly and affects both eyes or can have a rapid onset.
HBV test - Abbott RealTime HBV Assay - P080026
This medical device was FDA approved on August 13, 2010 and is a lab kit. It works by measuring blood levels of hepatitis B viral DNA. The test is used (along with other lab tests and clinical information) to measure an individual (infected by the HBV - hepatitis B virus) prior to and during treatment and provides a quantitative analysis of how the patient is responding to treatment.
Defibrillator - Boston Scientific Cardiac Resynchronization Therapy Defibrillators - P010012/S230
This medical device was FDA approved on September 16, 2010. The Resynchronization Therapy Defibrillator (CRT-D) is an implantable (below the collar bone under the skin) medical device that is used for therapy – by delivering small electrical impulses to the heart. The pulses help synchronize heart beats.
The three leads of the medical device are placed: the right atrium (of the heart), the right ventricle and the last lead is placed on the coronary vein of the left ventricle.
The medical device senses and works to correct problems (abnormal heart rhythms) also know as arrhythmias.
An arrhythmia is a heart disorder that affects the rhythm of the heart. This can result if the heart beats come at abnormal pulses (i.e. irregular pattern) or if the heart beats too fast or too slow (bradycardia, tachycardia respectively).
Intraocular Lens - EC-3 Posterior Chamber Intraocular Lenses (IOLs)
EC-3 Posterior Chamber Intraocular Lenses (IOLs), Models EC-3 and EC-3 Precision Aspheric Lens (PAL) - P100016
The medical device was FDA approved on October 19, 2010.
This device is used to replace the natural lens of the eye and restore image. It is used after the lens is removed during cataract surgery.
The difference between the two is the shape of the circular portion of the artificial lens.
It is indicated for patients who have had their natural lens removed during cataract surgery.
Cancer Test - Dako HercepTest™ - P980018/S010
Dako HercepTest™ - P980018/S010
The medical device was FDA approved on October 20, 2010. HercepTest™ is a lab test that is used to quantify the HER2 protein being produced by cancer cells.
It was previously used to detect protein made by breast cancer cells and now has the indication to test for spreading stomach cancer (cancer that has gone metastatic).
The test along with other lab tests will determine candidates for Herceptin® therapy.
Cancer Test - Dako HER2 FISH pharmDx™ - P040005/S005
Dako HER2 FISH pharmDx™ - P040005/S005
This medical device was FDA approved on October 20, 2010.
The HER2 FISH pharmDx™ is a lab test that uses fluorescent dye to detect the HER2 gene located on Chromosome #17. The tagged DNA probes attach themselves allowing the detection of the gene. The method is also known as the FISH or fluorescent in situ hybridization method.
The method has been used for the detection of breast cancer and now has the new indication for detecting metastatic (spreading) stomach cancer.
Fig.1 Fish or fluorescent in situ hybridization method – allows researchers to visualize the genetic material in a subject’s cells. It has the specificity of single gene or even segments of a gene which is referred to Locus specific probes. It doesn’t have to be performed on cells that are actually undergoing division.
KODAK DirectView CR Mammography System - P080018
KODAK DirectView CR Mammography System - P080018
FDA Approved on November 3rd, 2010, the product is manufactured by Carestream Health – a subdivision of Kodak
This medical device is a mammography system that utilizes the Kodak Directview CR Mammography Cassette. It utilizes an X-ray generator to produce mammography images on both hard copy (printed on film) and soft copy (digital image format).
The device is used for diagnosis in mammography but also has the indication for screening (i.e. for cancer, abnormalities, etc).
Note: Since the FDA Approval of this product the FDA has come out with less stringent regulations for submitting applications. They are now accepting 510(k) applications for CR Mammography units that have appropriate medical device predicats.
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