FDA Will Strengthen The Supervision Of Used Home Medical Equipment.
As the citizenry ages and medical technology improves, more subjects are using complex medical devices such as dialysis machines and ventilators at home, adding to the requisite for better-educated patients. To join this growing need, the US Food and Drug Administration announced Tuesday that it has started a unfamiliar program to ensure that patients and their caregivers use these devices safely and effectively.
So "Medical gubbins home use is becoming an increasingly important public health issue," Dr Jeffrey Shuren, chief of the FDA's Center for Devices and Radiological Health said during an afternoon news conference. The US populace is aging, and more people are living longer with chronic diseases that demand home care. "In addition, more patients of all ages are being discharged from the hospital to continue their supervision at home".
Meanwhile, medical devices have become more portable and sophisticated, making it possible to treat and monitor long-lived conditions outside the hospital. "A significant number of devices including infusion pumps, ventilators and mortification care therapies are now being used for home care".
Given the growing number of home medical devices, the intervention plans on developing procedures for makers of home-care equipment. Procedures will incorporate post-marketing follow-up, and other things that will encourage the safe use of these devices. The FDA is also developing eye-opening materials on the safe use of these devices, the agency said.
Showing posts with label device. Show all posts
Showing posts with label device. Show all posts
Tuesday 21 January 2020
Friday 2 March 2018
New Treatment For Migraine
New Treatment For Migraine.
The US Food and Drug Administration has approved the commencement thingamajig aimed at easing the pain of migraines preceded by aura - sensory disturbances that come about just before an attack. About a third of migraine sufferers experience auras. The Cerena Transcranial Magnetic Stimulator would be obtained through prescription, the FDA said in a asseveration released Friday Dec, 2013. Patients use both hands to hold the mark of cadency against the back of their head and press a button so that the coat of arms can release a pulse of magnetic energy. This pulse stimulates the brain's occipital cortex, which may stem or ease migraine pain.
And "Millions of people suffer from migraines, and this rejuvenated device represents a new treatment option for some patients," Christy Foreman, director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in the statement. The agency's concurrence is based on a adversity involving 201 patients who had suffered moderate-to-strong migraine with aura.
The US Food and Drug Administration has approved the commencement thingamajig aimed at easing the pain of migraines preceded by aura - sensory disturbances that come about just before an attack. About a third of migraine sufferers experience auras. The Cerena Transcranial Magnetic Stimulator would be obtained through prescription, the FDA said in a asseveration released Friday Dec, 2013. Patients use both hands to hold the mark of cadency against the back of their head and press a button so that the coat of arms can release a pulse of magnetic energy. This pulse stimulates the brain's occipital cortex, which may stem or ease migraine pain.
And "Millions of people suffer from migraines, and this rejuvenated device represents a new treatment option for some patients," Christy Foreman, director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in the statement. The agency's concurrence is based on a adversity involving 201 patients who had suffered moderate-to-strong migraine with aura.
Thursday 28 December 2017
Implantable Devices Are Not A Panacea, But The Ability To Relieve Migraine Attacks
Implantable Devices Are Not A Panacea, But The Ability To Relieve Migraine Attacks.
An implantable plot covert in the nape of the neck may excellent more headache-free days for people with severe migraines that don't respond to other treatments, a unknown study suggests. More than 36 million Americans get migraine headaches, which are marked by perfervid pain, sensitivity to light and sound, nausea and vomiting, according to the Migraine Research Foundation. Medication and lifestyle changes are the first-line treatments for migraine, but not one and all improves with these measures.
The St Jude Medical Genesis neurostimulator is a short, all skin and bones strip that is implanted behind the neck. A battery bunch is then implanted elsewhere in the body. Activating the device stimulates the occipital nerve and can crepuscular the pain of migraine headache. "There are a large number of patients for whom nothing works and whose lives are ruined by the circadian pain of their migraine headache, and this device has the potential to help some of them," said scan author Dr Stephen D Silberstein, director of the Jefferson Headache Center in Philadelphia.
The study, which was funded by monogram manufacturer St Jude Medical Inc, is slated for debut on Thursday at the International Headache Congress in Berlin, and is the largest study to date on the device. The partnership is now seeking approval for the device in Europe and then plans to submit their data to the US Food and Drug Administration for sanction in the United States.
Researchers tested the new device in 157 populace who had severe migraines about 26 days out of each month. After 12 weeks, those who received the restored device had seven more headache-free days per month, compared to one more headache-free day per month seen amongst people in the control group.
Individuals in the control arm did not receive stimulation until after the anything else 12 weeks. Study participants who received the stimulator also reported less severe headaches and improvements in their dignity of life. After one year, 66 percent of people in the study said they had ripping or good pain relief.
The pain reduction seen in the study did fall short of FDA standards, which whoop for a 50 percent reduction in pain. "The device is invisible to the eye, but not to the touch". The implantation course of action involves local anesthesia along with conscious sedation so you are awake, but not fully aware.
There may be some forbearing pain associated with this surgery. Study co-author Dr Joel Saper, collapse and director of Michigan Head Pain and Neurological Institute in Ann Arbor, and a associate of the advisory board for the Migraine Research Foundation, said this therapy could be an important option for some bodies with migraines.
An implantable plot covert in the nape of the neck may excellent more headache-free days for people with severe migraines that don't respond to other treatments, a unknown study suggests. More than 36 million Americans get migraine headaches, which are marked by perfervid pain, sensitivity to light and sound, nausea and vomiting, according to the Migraine Research Foundation. Medication and lifestyle changes are the first-line treatments for migraine, but not one and all improves with these measures.
The St Jude Medical Genesis neurostimulator is a short, all skin and bones strip that is implanted behind the neck. A battery bunch is then implanted elsewhere in the body. Activating the device stimulates the occipital nerve and can crepuscular the pain of migraine headache. "There are a large number of patients for whom nothing works and whose lives are ruined by the circadian pain of their migraine headache, and this device has the potential to help some of them," said scan author Dr Stephen D Silberstein, director of the Jefferson Headache Center in Philadelphia.
The study, which was funded by monogram manufacturer St Jude Medical Inc, is slated for debut on Thursday at the International Headache Congress in Berlin, and is the largest study to date on the device. The partnership is now seeking approval for the device in Europe and then plans to submit their data to the US Food and Drug Administration for sanction in the United States.
Researchers tested the new device in 157 populace who had severe migraines about 26 days out of each month. After 12 weeks, those who received the restored device had seven more headache-free days per month, compared to one more headache-free day per month seen amongst people in the control group.
Individuals in the control arm did not receive stimulation until after the anything else 12 weeks. Study participants who received the stimulator also reported less severe headaches and improvements in their dignity of life. After one year, 66 percent of people in the study said they had ripping or good pain relief.
The pain reduction seen in the study did fall short of FDA standards, which whoop for a 50 percent reduction in pain. "The device is invisible to the eye, but not to the touch". The implantation course of action involves local anesthesia along with conscious sedation so you are awake, but not fully aware.
There may be some forbearing pain associated with this surgery. Study co-author Dr Joel Saper, collapse and director of Michigan Head Pain and Neurological Institute in Ann Arbor, and a associate of the advisory board for the Migraine Research Foundation, said this therapy could be an important option for some bodies with migraines.
Thursday 22 June 2017
Device Resynchronization Therapy-Defibrillator Prolongs Life Of Patients With Heart Failure
Device Resynchronization Therapy-Defibrillator Prolongs Life Of Patients With Heart Failure.
Canadian researchers on that an implantable badge called a resynchronization therapy-defibrillator helps remain the left side of the heart pumping properly, extending the life of heart breakdown patients. Cardiac-resynchronization therapy, or CRT-D, also reduces heart failure symptoms, such as edema (swelling) and shortness of breath, as well as hospitalizations for some patients with reasonable to severe heart failure, the scientists added. "The unharmed idea of the therapy is to try to resynchronize the heart," said lead researcher Dr Anthony SL Tang, from the University of British Columbia in Vancouver.
It improves the heart's skill to pact and pump blood throughout the body. This study demonstrates that, in adding up to symptom relief, the CRT-D extends life and keeps heart failure patients out of the hospital. Tang added that patients will endure to need medical therapy and an implantable cardioverter-defibrillator (ICD) in totting up to a CRT-D.
And "We are saying people who are receiving good medical therapy and are now active to get a defibrillator, please go ahead and also do resynchronization therapy as well. This is worthwhile, because they will live longer and be more like as not to stay out of the hospital". The report is published in the Nov 14, 2010 online number of the New England Journal of Medicine, to coincide with a scheduled presentation of the findings Sunday at the American Heart Association annual session in Chicago.
Tang's team randomly assigned 1,798 patients with bland or moderate heart failure to have a CRT-D plus an ICD implanted or only an ICD implanted. Over 40 months of follow-up, the researchers found that those who received both devices capable a 29 percent reduction in their symptoms, compared with patients who did not be given the resynchronization device. In addition, there was a 27 percent reduction in deaths and guts failure hospitalizations among those who also had a CRT-D, they found.
More than 22 million kinfolk worldwide, including 6 million patients in the United States, endure from heart failure. These patients' hearts cannot adequately pump blood through the body. And although deaths from humanity disease have fallen over the last three decades, the death bawl out for heart failure is rising, the researchers said. Treating heart failure is also expensive, costing an estimated $40 billion each year in the United States alone.
In cardiac-resynchronization therapy, a stopwatch-sized artifice is implanted in the loftier chest to resynchronize the contractions of the heart's upper chambers, called ventricles. This is done by sending electrical impulses to the empathy muscle. Resynchronizing the contractions of the ventricles can relieve the heart pump blood throughout the body more efficiently.
Canadian researchers on that an implantable badge called a resynchronization therapy-defibrillator helps remain the left side of the heart pumping properly, extending the life of heart breakdown patients. Cardiac-resynchronization therapy, or CRT-D, also reduces heart failure symptoms, such as edema (swelling) and shortness of breath, as well as hospitalizations for some patients with reasonable to severe heart failure, the scientists added. "The unharmed idea of the therapy is to try to resynchronize the heart," said lead researcher Dr Anthony SL Tang, from the University of British Columbia in Vancouver.
It improves the heart's skill to pact and pump blood throughout the body. This study demonstrates that, in adding up to symptom relief, the CRT-D extends life and keeps heart failure patients out of the hospital. Tang added that patients will endure to need medical therapy and an implantable cardioverter-defibrillator (ICD) in totting up to a CRT-D.
And "We are saying people who are receiving good medical therapy and are now active to get a defibrillator, please go ahead and also do resynchronization therapy as well. This is worthwhile, because they will live longer and be more like as not to stay out of the hospital". The report is published in the Nov 14, 2010 online number of the New England Journal of Medicine, to coincide with a scheduled presentation of the findings Sunday at the American Heart Association annual session in Chicago.
Tang's team randomly assigned 1,798 patients with bland or moderate heart failure to have a CRT-D plus an ICD implanted or only an ICD implanted. Over 40 months of follow-up, the researchers found that those who received both devices capable a 29 percent reduction in their symptoms, compared with patients who did not be given the resynchronization device. In addition, there was a 27 percent reduction in deaths and guts failure hospitalizations among those who also had a CRT-D, they found.
More than 22 million kinfolk worldwide, including 6 million patients in the United States, endure from heart failure. These patients' hearts cannot adequately pump blood through the body. And although deaths from humanity disease have fallen over the last three decades, the death bawl out for heart failure is rising, the researchers said. Treating heart failure is also expensive, costing an estimated $40 billion each year in the United States alone.
In cardiac-resynchronization therapy, a stopwatch-sized artifice is implanted in the loftier chest to resynchronize the contractions of the heart's upper chambers, called ventricles. This is done by sending electrical impulses to the empathy muscle. Resynchronizing the contractions of the ventricles can relieve the heart pump blood throughout the body more efficiently.
Monday 16 January 2017
New Methods Of Diagnosis Of Stroke
New Methods Of Diagnosis Of Stroke.
The opener to correctly diagnosing when a instance of dizziness is just vertigo or a life-threatening stroke may be surprisingly simple: a pair of goggles that measures look movement at the bedside in as little as one minute, a new study contends. "This is the in front study demonstrating that we can accurately discriminate strokes and non-strokes using this device," said Dr David Newman-Toker, first author of a paper on the technique that is published in the April issue of the minute-book Stroke. Some 100000 strokes are misdiagnosed as something else each year in the United States, resulting in 20000 to 30000 deaths or demanding physical and speech impairments, the researchers said.
As with insensitivity attacks, the key to treating stroke and potentially saving a person's life is speed. Magnetic resonance imaging (MRI), the progress gold standard for assessing stroke, can take up to six hours to ended and costs $1200, said Newman-Toker, who is an associate professor of neurology and otolaryngology at Johns Hopkins Hospital in Baltimore. Sometimes grass roots don't even get as far as an MRI, and may be sent retreat with a first "mini stroke" that is followed by a devastating second stroke.
The new study findings come with some significant caveats, however. For one thing, the scrutiny was a small one, involving only 12 patients. "It is unworkable for a small study to prove 100 percent accuracy," said Dr Daniel Labovitz, the man of the Stern Stroke Center at Montefiore Medical Center in New York City, who was not complex with the study. About 4 percent of dizziness cases in the emergency area are caused by stroke.
The other caveat is that the device is not yet approved in the United States for diagnosing stroke. The US Food and Drug Administration only recently gave it licence for use in assessing balance. It has been at one's disposal in Europe for that purpose for about a year. The device - known as a video-oculography machine - is a modification of a "head impulse test," which is Euphemistic pre-owned regularly for people with chronic dizziness and other inner ear-balance disorders.
The opener to correctly diagnosing when a instance of dizziness is just vertigo or a life-threatening stroke may be surprisingly simple: a pair of goggles that measures look movement at the bedside in as little as one minute, a new study contends. "This is the in front study demonstrating that we can accurately discriminate strokes and non-strokes using this device," said Dr David Newman-Toker, first author of a paper on the technique that is published in the April issue of the minute-book Stroke. Some 100000 strokes are misdiagnosed as something else each year in the United States, resulting in 20000 to 30000 deaths or demanding physical and speech impairments, the researchers said.
As with insensitivity attacks, the key to treating stroke and potentially saving a person's life is speed. Magnetic resonance imaging (MRI), the progress gold standard for assessing stroke, can take up to six hours to ended and costs $1200, said Newman-Toker, who is an associate professor of neurology and otolaryngology at Johns Hopkins Hospital in Baltimore. Sometimes grass roots don't even get as far as an MRI, and may be sent retreat with a first "mini stroke" that is followed by a devastating second stroke.
The new study findings come with some significant caveats, however. For one thing, the scrutiny was a small one, involving only 12 patients. "It is unworkable for a small study to prove 100 percent accuracy," said Dr Daniel Labovitz, the man of the Stern Stroke Center at Montefiore Medical Center in New York City, who was not complex with the study. About 4 percent of dizziness cases in the emergency area are caused by stroke.
The other caveat is that the device is not yet approved in the United States for diagnosing stroke. The US Food and Drug Administration only recently gave it licence for use in assessing balance. It has been at one's disposal in Europe for that purpose for about a year. The device - known as a video-oculography machine - is a modification of a "head impulse test," which is Euphemistic pre-owned regularly for people with chronic dizziness and other inner ear-balance disorders.
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