Treating Morbid Extreme Obesity.
A first-of-its-kind insert that curbs the craving by electrically stimulating stomach nerves was approved Wednesday by the US Food and Drug Administration. The Maestro Rechargeable System is intended to handle sad (extreme) obesity, emblem manufacturer EnteroMedics Inc said in its operation for FDA approval. The implant sends electrical signals to nerves around the tummy that help control digestion vigrx plus precio en mississippi. These signals balk the nerves, decreasing hunger pangs and making the child feel full.
The FDA approved the stratagem for use in people 18 and older who have a body-mass index (BMI) of 35 to 45 and at least one other obesity-related condition, such as personification 2 diabetes. BMI is a correspondence that determines body fat based on a person's elevation and weight. For example, a person who's 5 feet, 8 inches huge and weighs 230 pounds has a BMI of 35. People with a BMI of 30 or higher are considered obese, according to the US Centers for Disease Control and Prevention.
People receiving a Maestro ingraft also must have tried and failed to forfeit charge with a usual weight loss program, the FDA said. The mark of cadency is the first FDA-approved obesity monogram since 2007. In clinical trials, people with a Maestro indoctrinate lost an average 8,5 percent more weight after one year than others who received a factitious implant. About half of the implanted patients down the drain at least 20 percent of their excess weight, and 38 percent wrecked at least 25 percent of their leftovers weight.
EnteroMedics reported that people with fake implants regained about 40 percent of the superiority they had lost within six months of the trial's end, while the mobile vulgus with the Maestro device appeared to authorize their weight loss. According to the CDC, more than one-third of all US adults are obese, and mortals with obesity are at increased risk of heart disease, stroke, classification 2 diabetes and certain cancers.
And "Obesity and its kindred medical conditions are major public haleness problems," Dr William Maisel, chief scientist in the FDA's Center for Devices and Radiological Health, said in an power flash release. "Medical devices can help physicians and patients to come forth comprehensive obesity treatment plans". As corner of the FDA approval, Minnesota-based EnteroMedics must conduct a five-year post-approval analyse that will follow at least 100 patients and collect additional sanctuary and effectiveness data.
Showing posts with label device. Show all posts
Showing posts with label device. Show all posts
Wednesday, June 26, 2019
Tuesday, April 23, 2019
New treatment for migraine
New treatment for migraine.
The US Food and Drug Administration has approved the foremost legend aimed at easing the soreness of migraines preceded by aura - sensory disturbances that arise just before an attack. About a third of migraine sufferers trial auras. The Cerena Transcranial Magnetic Stimulator would be obtained through prescription, the FDA said in a proclamation released Friday Dec, 2013. Patients use both hands to hold the ruse against the back of their cranium and press a button so that the device can release a pulse of charismatic energy white sugar daddy in port elizabeth. This pulse stimulates the brain's occipital cortex, which may obstruction or ease migraine pain.
And "Millions of subjects suffer from migraines, and this new device represents a new care 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 agreement is based on a hard times involving 201 patients who had suffered moderate-to-strong migraine with aura.
The US Food and Drug Administration has approved the foremost legend aimed at easing the soreness of migraines preceded by aura - sensory disturbances that arise just before an attack. About a third of migraine sufferers trial auras. The Cerena Transcranial Magnetic Stimulator would be obtained through prescription, the FDA said in a proclamation released Friday Dec, 2013. Patients use both hands to hold the ruse against the back of their cranium and press a button so that the device can release a pulse of charismatic energy white sugar daddy in port elizabeth. This pulse stimulates the brain's occipital cortex, which may obstruction or ease migraine pain.
And "Millions of subjects suffer from migraines, and this new device represents a new care 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 agreement is based on a hard times involving 201 patients who had suffered moderate-to-strong migraine with aura.
Friday, February 22, 2019
New Methods Of Diagnosis Of Stroke
New Methods Of Diagnosis Of Stroke.
The clue to correctly diagnosing when a lawsuit of dizziness is just wooziness or a life-threatening stroke may be surprisingly simple: a pair of goggles that measures leer movement at the bedside in as little as one minute, a unique study contends. "This is the first study demonstrating that we can accurately segregate strokes and non-strokes using this device," said Dr David Newman-Toker, leash author of a paper on the technique that is published in the April climax of the journal Stroke click here. Some 100000 strokes are misdiagnosed as something else each year in the United States, resulting in 20000 to 30000 deaths or savage natural and speech impairments, the researchers said.
As with basics attacks, the key to treating strike and potentially saving a person's life is speed. Magnetic resonance imaging (MRI), the on the qui vive gold standard for assessing stroke, can believe up to six hours to complete and costs $1200, said Newman-Toker, who is an confidant professor of neurology and otolaryngology at Johns Hopkins Hospital in Baltimore. Sometimes hoi polloi don't even get as far as an MRI, and may be sent people's home with a first "mini stroke" that is followed by a caustic second stroke.
The new study findings come with some significant caveats, however. For one thing, the analysis was a small one, involving only 12 patients. "It is unachievable for a small study to uphold 100 percent accuracy," said Dr Daniel Labovitz, conductor of the Stern Stroke Center at Montefiore Medical Center in New York City, who was not confusing with the study. About 4 percent of dizziness cases in the exigency range 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 blessing for use in assessing balance. It has been present in Europe for that purposefulness for about a year. The device - known as a video-oculography automobile - is a modification of a "head impulse test," which is reach-me-down regularly for people with chronic dizziness and other inner ear-balance disorders.
The clue to correctly diagnosing when a lawsuit of dizziness is just wooziness or a life-threatening stroke may be surprisingly simple: a pair of goggles that measures leer movement at the bedside in as little as one minute, a unique study contends. "This is the first study demonstrating that we can accurately segregate strokes and non-strokes using this device," said Dr David Newman-Toker, leash author of a paper on the technique that is published in the April climax of the journal Stroke click here. Some 100000 strokes are misdiagnosed as something else each year in the United States, resulting in 20000 to 30000 deaths or savage natural and speech impairments, the researchers said.
As with basics attacks, the key to treating strike and potentially saving a person's life is speed. Magnetic resonance imaging (MRI), the on the qui vive gold standard for assessing stroke, can believe up to six hours to complete and costs $1200, said Newman-Toker, who is an confidant professor of neurology and otolaryngology at Johns Hopkins Hospital in Baltimore. Sometimes hoi polloi don't even get as far as an MRI, and may be sent people's home with a first "mini stroke" that is followed by a caustic second stroke.
The new study findings come with some significant caveats, however. For one thing, the analysis was a small one, involving only 12 patients. "It is unachievable for a small study to uphold 100 percent accuracy," said Dr Daniel Labovitz, conductor of the Stern Stroke Center at Montefiore Medical Center in New York City, who was not confusing with the study. About 4 percent of dizziness cases in the exigency range 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 blessing for use in assessing balance. It has been present in Europe for that purposefulness for about a year. The device - known as a video-oculography automobile - is a modification of a "head impulse test," which is reach-me-down regularly for people with chronic dizziness and other inner ear-balance disorders.
Thursday, November 12, 2015
FDA Will Strengthen The Supervision Of Used Home Medical Equipment
FDA Will Strengthen The Supervision Of Used Home Medical Equipment.
As the citizenry ages and medical technology improves, more living souls are using complex medical devices such as dialysis machines and ventilators at home, adding to the poverty for better-educated patients online. To link up this growing need, the US Food and Drug Administration announced Tuesday that it has started a unusual program to secure that patients and their caregivers use these devices safely and effectively.
So "Medical gadget diggings use is becoming an increasingly weighty public health issue," Dr Jeffrey Shuren, conductor of the FDA's Center for Devices and Radiological Health said during an afternoon release conference. The US population is aging, and more relatives are living longer with chronic diseases that be lacking home care. "In addition, more patients of all ages are being discharged from the dispensary to continue their care at home".
Meanwhile, medical devices have become more carry-on and sophisticated, making it possible to treat and monitor inveterate conditions outside the hospital. "A significant number of devices including infusion pumps, ventilators and slit care therapies are now being worn for home care".
Given the growing number of home medical devices, the means plans on developing procedures for makers of home-care equipment. Procedures will contain post-marketing follow-up, and other things that will help the safe use of these devices. The FDA is also developing scholastic materials on the safe use of these devices, the agency said.
As the citizenry ages and medical technology improves, more living souls are using complex medical devices such as dialysis machines and ventilators at home, adding to the poverty for better-educated patients online. To link up this growing need, the US Food and Drug Administration announced Tuesday that it has started a unusual program to secure that patients and their caregivers use these devices safely and effectively.
So "Medical gadget diggings use is becoming an increasingly weighty public health issue," Dr Jeffrey Shuren, conductor of the FDA's Center for Devices and Radiological Health said during an afternoon release conference. The US population is aging, and more relatives are living longer with chronic diseases that be lacking home care. "In addition, more patients of all ages are being discharged from the dispensary to continue their care at home".
Meanwhile, medical devices have become more carry-on and sophisticated, making it possible to treat and monitor inveterate conditions outside the hospital. "A significant number of devices including infusion pumps, ventilators and slit care therapies are now being worn for home care".
Given the growing number of home medical devices, the means plans on developing procedures for makers of home-care equipment. Procedures will contain post-marketing follow-up, and other things that will help the safe use of these devices. The FDA is also developing scholastic materials on the safe use of these devices, the agency said.
Friday, September 6, 2013
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 gubbins unseen in the nape of the neck may exceptional more headache-free days for populace with severe migraines that don't rejoin to other treatments, a new study suggests. More than 36 million Americans get migraine headaches, which are prominent by animated pain, sensitivity to light and sound, nausea and vomiting, according to the Migraine Research Foundation vitoviga. Medication and lifestyle changes are the first-line treatments for migraine, but not person improves with these measures.
The St Jude Medical Genesis neurostimulator is a short, scant swathe that is implanted behind the neck. A battery deck is then implanted elsewhere in the body. Activating the logotype stimulates the occipital nerve and can obscured the pain of migraine headache. "There are a large number of patients for whom nothing mechanism and whose lives are ruined by the daily pain of their migraine headache, and this ruse has the potential to help some of them," said weigh author Dr Stephen D Silberstein, director of the Jefferson Headache Center in Philadelphia.
The study, which was funded by logo industrialist St Jude Medical Inc, is slated for delivery on Thursday at the International Headache Congress in Berlin, and is the largest review to date on the device. The company is now seeking approval for the design in Europe and then plans to submit their data to the US Food and Drug Administration for imprimatur in the United States.
Researchers tested the unusual device in 157 people who had severe migraines about 26 days out of each month. After 12 weeks, those who received the revitalized mark of cadency had seven more headache-free days per month, compared to one more headache-free date per month seen among people in the conduct group.
Individuals in the control arm did not receive stimulation until after the victory 12 weeks. Study participants who received the stimulator also reported less savage headaches and improvements in their quality of life. After one year, 66 percent of populate in the study said they had peerless or good pain relief.
The pain reduction seen in the study did succumb short of FDA standards, which call for a 50 percent reduction in pain. "The emblem is invisible to the eye, but not to the touch," said Silberstein. The implantation ways and means involves neighbourhood anesthesia along with conscious sedation so you are awake, but not fully aware.
There may be some calming pain associated with this surgery, he said. Study co-author Dr Joel Saper, establisher and director of Michigan Head Pain and Neurological Institute in Ann Arbor, and a colleague of the hortatory board for the Migraine Research Foundation, said this treatment could be an important option for some people with migraines.
An implantable gubbins unseen in the nape of the neck may exceptional more headache-free days for populace with severe migraines that don't rejoin to other treatments, a new study suggests. More than 36 million Americans get migraine headaches, which are prominent by animated pain, sensitivity to light and sound, nausea and vomiting, according to the Migraine Research Foundation vitoviga. Medication and lifestyle changes are the first-line treatments for migraine, but not person improves with these measures.
The St Jude Medical Genesis neurostimulator is a short, scant swathe that is implanted behind the neck. A battery deck is then implanted elsewhere in the body. Activating the logotype stimulates the occipital nerve and can obscured the pain of migraine headache. "There are a large number of patients for whom nothing mechanism and whose lives are ruined by the daily pain of their migraine headache, and this ruse has the potential to help some of them," said weigh author Dr Stephen D Silberstein, director of the Jefferson Headache Center in Philadelphia.
The study, which was funded by logo industrialist St Jude Medical Inc, is slated for delivery on Thursday at the International Headache Congress in Berlin, and is the largest review to date on the device. The company is now seeking approval for the design in Europe and then plans to submit their data to the US Food and Drug Administration for imprimatur in the United States.
Researchers tested the unusual device in 157 people who had severe migraines about 26 days out of each month. After 12 weeks, those who received the revitalized mark of cadency had seven more headache-free days per month, compared to one more headache-free date per month seen among people in the conduct group.
Individuals in the control arm did not receive stimulation until after the victory 12 weeks. Study participants who received the stimulator also reported less savage headaches and improvements in their quality of life. After one year, 66 percent of populate in the study said they had peerless or good pain relief.
The pain reduction seen in the study did succumb short of FDA standards, which call for a 50 percent reduction in pain. "The emblem is invisible to the eye, but not to the touch," said Silberstein. The implantation ways and means involves neighbourhood anesthesia along with conscious sedation so you are awake, but not fully aware.
There may be some calming pain associated with this surgery, he said. Study co-author Dr Joel Saper, establisher and director of Michigan Head Pain and Neurological Institute in Ann Arbor, and a colleague of the hortatory board for the Migraine Research Foundation, said this treatment could be an important option for some people with migraines.
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