FDA Permits Marketing Miris Human Milk Analyzer Diagnostic Test To Aid Healthcare Professionals

Miris HMA - Human Milk Analyzer from Camilla Sandberg on Vimeo.

The U.S. Food and Drug Administration, FDA, allowed marketing of the Miris Human Milk Analyzer in the USA.,THe Miris Device is a new diagnostic test to aid healthcare professionals to analyze and measure nutrients in breast milk. The measurements include the concentration of fat, carbohydrate, protein, total solids and energy. These results of the analysis will provide healthcare professionals with a new tool to aid in the nutritional management of newborns and young infants at risk for growth failure due to prematurity or other medical conditions.

“Breast milk provides many health benefits to infants, and for many babies it can meet their early nutritional needs. But some infants — including those who may be born preterm or have certain health conditions — may need additional nutrients in order to support their optimal growth. For the first time, doctors have access to a test to help analyze the nutrients in breast milk. While this test is not for everyone, it has the potential to aid parents and healthcare providers, mainly in a hospital setting, in better assessing the nutrient needs of certain babies who are not growing as expected.” said Courtney Lias, Ph.D. director of the Division of Chemistry and Toxicology Devices in the FDA’s Center for Devices and Radiological Health.

FDA Release

Today, the U.S. Food and Drug Administration permitted marketing of the Miris Human Milk Analyzer, a new diagnostic test to aid healthcare professionals in measuring nutrients in breast milk, including the concentration of fat, carbohydrate, protein, total solids and energy. The test provides healthcare professionals with a new tool to aid in the nutritional management of newborns and young infants at risk for growth failure due to prematurity or other medical conditions.

“Breast milk provides many health benefits to infants, and for many babies it can meet their early nutritional needs. But some infants — including those who may be born preterm or have certain health conditions — may need additional nutrients in order to support their optimal growth."said Courtney Lias, Ph.D. director of the Division of Chemistry and Toxicology Devices in the FDA’s Center for Devices and Radiological Health. "For the first time, doctors have access to a test to help analyze the nutrients in breast milk. While this test is not for everyone, it has the potential to aid parents and healthcare providers, mainly in a hospital setting, in better assessing the nutrient needs of certain babies who are not growing as expected.”

Some infants who are born prematurely or with health conditions may have special nutritional needs. Breast milk composition can vary in individuals, and, in certain cases, breast milk may not contain sufficient protein and energy levels for these infants with increased nutrient needs. In those instances, healthcare professionals may want to test the nutrient content of the milk to help guide nutritional care. Knowing the macronutrient content of the breast milk may help the health care team and parents make informed decisions on how to fortify the breast milk based on the individual needs of the infant.

The Miris Human Milk Analyzer uses an infrared spectroscopy system to analyze samples of human milk and provide a quantitative measurement of fat, protein and total carbohydrate content as well as calculations of the total solids and energy content contained in the milk. This is a prescription device intended for use by trained health care personnel at clinical laboratories.

The FDA reviewed data submitted by the sponsor of 112 samples of human milk to analyze the performance of the device. For the study, the sponsor tested the same 112 samples in the machine and compared them to the expected true values obtained by independent methods; both systems provided similar results for each test. The data showed that the Miris Human Milk Analyzer test was effective at determining levels of protein, fat and carbohydrate in the milk. There may be conditions that limit the information available from the Miris Human Milk Analyzer. For example, certain medications that a nursing mother may be taking could interfere with the test’s ability to accurately measure nutrient levels in breast milk.

Health care professionals should carefully evaluate the Miris Human Milk Analyzer test results in conjunction with clinical assessments (such as weight and growth) to inform their discussions with parents in creating a nutritional management plan for an infant or newborn.

The FDA reviewed the Miris Human Milk Analyzer test through the De Novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. Along with this authorization, the FDA is establishing criteria, called special controls, to provide for the accuracy and reliability of tests intended to measure the nutritional content of human milk to aid in the nutritional management of certain infants. These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type, including the same intended use, may go through the FDA’s 510(k) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

The FDA granted marketing authorization of the Miris Human Milk Analyzer test to Miris AB.

Medical Device Makers Led By Medtronic, Baxter and Abbot, Spend Millions Lobbying For Deregulations.

NBC News reports steps taken by Medical device manufacturers to loosen the laws and rules governing those devices. It is an alarming revelation that everyone must be aware of.  Simply put, a cardiologist had this to say;
“It makes things easier for industry, it makes things worse for patients,” said cardiologist Rita Redberg about a recent industry-backed rule change.

After Teresa Hershey nearly died from complications of a hysterectomy, she wanted future patients to know about the potential dangers of choosing robotic surgery for the operation. In 2013, the California woman added a detailed account of how the robot that operated on her had burned a hole in her bowels to a database maintained by the Food and Drug Administration.

The database is meant to warn the medical community about the risks associated with medical devices. Hershey’s was one of hundreds of similar accounts about the same robotic device.

But earlier this year, the FDA made a rule change that could curtail that database, which was already considered to be of limited scope by medical researchers and the FDA itself.

Portable Migraine Zapper Tested

Portable device effective in zapping away migraine pain

COLUMBUS, Ohio – A novel electronic device designed to "zap" away migraine pain before it starts has proven to be the next form of relief for those suffering from the debilitating disease, according to a study conducted at The Ohio State University Medical Center.

Results of the study, to be presented Friday (6/27) at the annual American Headache Society meeting in Boston, found that the experimental device is safe and effective in eliminating headaches when administered during the onset of the migraine.

With one in eight Americans suffering from chronic migraines, Dr. Yousef Mohammad, a neurologist and principal investigator of the study at Ohio State's Medical Center, says the study's results are promising given that only 50 to 60 percent of migraine patients respond to traditional migraine drug treatments.

The noninvasive transcranial magnetic stimulator (TMS) device interrupts the aura phase of the migraine, often described as electrical storms in the brain, before they lead to headaches. Migraine sufferers often describe "seeing" showers of shooting stars, zigzagging lines and flashing lights, and experiencing loss of vision, weakness, tingling or confusion, followed by intense throbbing head pain, nausea and vomiting.

Previous studies, conducted at Ohio State, using a heavy and bulky TMS device, reduced headache pain. To expedite treatment at home, a portable hand-held device was developed and tested.

"Stimulation with magnetic pulses from the portable TMS device proved effective for the migraine patients," said Mohammad. "Because of the lack of adverse events in this trial and the established safety of the TMS device, this is a promising treatment for migraines with aura. This sets the stage for future studies in migraines without aura."

The TMS device sends a strong electric current through a metal coil, which creates an intense magnetic field for about one millisecond. This magnetic pulse, when held against a person's head, creates an electric current in the neurons of the brain, interrupting the aura before it results in a throbbing headache.

"The device's pulses are painless and safe," Mohammad said. "Since almost all migraine drugs have some side effects, and patients are prone to addiction from narcotics, or developing headaches from frequent use of over-the-counter medication, the TMS device holds great promise for migraine sufferers."

Of the 164 patients involved in the multi-center, randomized clinical trial receiving TMS treatment, 39 percent were pain free at the two-hour post-treatment point, compared to 22 percent in the group receiving "sham" pulses. There were no differences reported related to adverse reactions between the two groups.

It was previously believed that migraine headaches start with vascular constriction, which results in an aura, followed by vascular dilation that will lead to a throbbing headache. However, in the late 1990's it was suggested that neuronal electrical hyperexcitablility resulted in a throbbing headache. This new understanding of the migraine mechanism assisted in the development of the TMS device.

Contact: Sherri L. Kirk
Sherri.Kirk@osumc.edu
614-293-3737
Ohio State University Medical Center

NeuraLieve, manufacturer of the device located in Sunnyvale, Ca., provided the funding and equipment for the study. Mohammad serves on the company's board of directors.

Tags: Medical Devices, migraine, American Headache Society, transcranial magnetic stimulator, NeuraLieve

NeuRx DPS RA/4 Respiratory Stimulation System Approved By FDA

FOR IMMEDIATE RELEASE June 18, 2008

Media Inquiries: Peper Long, 301-827-0599 Consumer Inquiries: 888-INFO-FDA

FDA Approves Diaphragm-Pacing Device
Device can help paralysis patients breathe without a ventilator for at least four hours

The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator.

Spinal cord injuries can cause paralysis, which can impact the muscles of the chest and abdomen, including the diaphragm—the lower abdominal muscle essential for breathing. Normally, a person inhales when the diaphragm contracts and the lungs expand with air—a person exhales when the diaphragm relaxes and the air flows back out of the lungs.

"While the NeuRx RA/4 does not cure paralysis of the diaphragm, allowing patients to be free from a mechanical ventilator for at least four hours a day may enhance their quality of life," said Daniel G. Schultz, M.D., director of the FDA's Center for Devices and Radiological Health.

Patients with severe spinal cord injuries who cannot control their diaphragms often need mechanical ventilation to help them breathe. This usually requires a full-time connection to a ventilation machine.

The NeuRx DPS RA/4 uses four electrodes implanted in the muscle of the diaphragm to electronically stimulate contraction; this stimulation allows the patient to inhale.

The FDA approved the distribution of this device under a Humanitarian Device Exemption, an approval process for devices intended to treat or diagnose conditions that affect fewer than 4,000 people per year.

In a multi-center trial, the device has been demonstrated to be safe and to have probable benefit to the patient by allowing at least four hours per day of freedom from a mechanical ventilator.

NeuRx DPS RA/4 is manufactured by Synapse Biomedical of Cleveland, Ohio.

Tags: FDA Approval, Medical Devices, Diaphragm-Pacing Device, Respiratory Stimulation System, NeuRx DPS RA/4, Synapse Biomedical of Cleveland

FDA Approves Coronary Artery Plaque Imaging Device.

Coronary Artery Plaque Imaging Device Cleared by FDA

The U.S. Food and Drug Administration has cleared for marketing a device that a doctor can use to see inside a blood vessel to assess the fat content of the plaque which builds up on the wall of the coronary arteries.

Plaque is a deposit made up of cholesterol-rich fat, calcium, and other substances found in the blood. As plaque accumulates on the artery wall, it reduces blood flow to the heart muscle and increases the risk of blood clots which can lead to a heart attack.

Nearly one million Americans suffer a heart attack every year and about half die. Many heart attacks occur when a fatty coronary plaque ruptures, forming dangerous blood clots. Pathologic studies of patients who died from heart attack have identified a large lipid (fatty) core among features of coronary artery disease that were associated with plaque rupture and thrombosis (blood clots). Research is currently underway to determine how plaques that are prone to rupture can best be identified before they cause a heart attack.

“This is the first device that can help assess the chemical make-up of coronary artery plaques and help physicians identify those plaques with lipid cores, which may be of particular concern,” said Daniel Schultz, M.D., director of the Center for Devices and Radiological Health.

The InfraReDx LipiScan NIR Catheter Imaging System uses infrared imaging to detect lipid core-containing plaques of interest and assess a patient's coronary artery lipid core burden index. The device works by placing a catheter equipped with a fiber-optic laser light into the artery. The device shines the near infrared light delivered through the blood to the artery wall, and measures the light reflected back from the artery wall, a technique called spectroscopy. The reflected wavelengths vary depending on how much fat and other substances are in the plaque in the illuminated portion of the wall.

LipiScan is manufactured by InfraReDx Inc. of Burlington, Mass. The device is cleared for use by physicians who are evaluating patients with symptoms of coronary heart disease during a heart test known as cardiac angiography, to help in detection of plaques that have lipid (fatty) cores.

tag: FDA Approval, Medical Devices, InfraReDx LipiScan NIR Catheter Imaging System, blood clots,

CONTAK RENEWAL® 3 AVT® Cardiac Resynchronization Defibrillator

Product Name: CONTAK RENEWAL® 3 AVT® Cardiac Resynchronization Defibrillator (CRT-D), Models M150, M155, M157, and M159
PMA Applicant:Guidant Corporation, a Boston Scientific Company
Address: 4100 Hamline Ave North , St. Paul, MN 55112
Approval Date: March 13, 2008
Approval Letter: In PDF Format

What is it? The CONTAK RENEWAL® 3 AVT CRT-D® is an implantable cardioverter defibrillator (ICD) that also delivers cardiac resynchronization therapy (CRT) and atrial therapies.

How does it work? The CONTAK RENEWAL® 3 AVT CRT-D® consists of an implantable pulse generator (IPG), made up of a battery and electronic circuitry connected to three independent leads (insulated wires). The IPG is usually implanted below the collarbone, just beneath the skin. The leads are placed in three different areas:

• One in an upper heart chamber (the right atrium)
• A second lead in a lower heart chamber (the right ventricle), and
• A third lead in a vein that overlies the left ventricle.

When the device is functioning as an ICD, it senses dangerous abnormal heart rhythms and shocks the heart back into a normal rhythm. The CRT portion of the device uses small electrical impulses to coordinate the beating of the left and right ventricles so that they work together more effectively to pump blood throughout the body. The atrial therapy portion of the device detects and treats rapid heart rates in the atrium with antitachycardia pacing or shock therapy.

When is it used? CONTAK RENEWAL® 3 AVT® is used in certain patients who have:

• symptoms of advanced heart failure despite taking heart failure medication, and
• a heart rhythm problem (arrhythmia) that may cause the lower chambers (ventricles) of the heart to beat in an uncoordinated manner
• and may have a history of or may develop heart rhythm problems in the upper chambers (atria) of the heart.

CONTAK RENEWAL® 3 AVT® CRT-Ds are indicated for patients with moderated to severe heart failure (NYHA III/IV) who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (EF /= 120 ms.

CONTAK RENEWAL® 3 AVT® provides atrial antitachycardia pacing and atrial defibrillation treatment for patients with a history of, or who are at risk of developing atrial arrhythmias.

What will it accomplish? CONTAK RENEWAL® 3 AVT® will deliver:

• CRT to help coordinate the beating of the heart, and
• A life-saving shock to attempt to return the heart to normal heart rhythm.

Together, these two therapies may reduce the combined risk of death or first hospitalization as well as the risk of death alone. It may also relieve some of the symptoms associated with heart failure, including shortness of breath and fatigue during exercise, which may result in a better quality of life.

CONTAK RENEWAL® 3 AVT® will also deliver:

• Atrial antitachycardia pacing and atrial defibrillation to terminate atrial arrhythmias.

When should it not be used? There is no contraindication for this device.

Additional information: The Summary of Safety and Effectiveness and labeling is available at FDA.

tag: Medical Devices, Medical Devices approvals, Defibrillator, CONTAK RENEWAL, Guidant Corporation,

FDA Approves FreeStyle Navigator® Continuous Glucose Monitoring System

Product Name: FreeStyle Navigator® Continuous Glucose Monitoring System
PMA Applicant:Abbott Diabetes Care
Address: 1360 South Loop Road, Alameda, CA 94502
Approval Date: March 12, 2008
Approval Letter: http://www.fda.gov/cdrh/pdf5/p050020a.pdf

What is it? The FreeStyle Navigator Glucose Monitoring System is a glucose sensor that reports glucose values continuously for up to 120 hours. These readings are used with fingerstick results to detect trends and patterns in glucose levels in adults, age 18 and over, with diabetes.

How does it work? The sensor is inserted in either the abdomen or the back of the upper arm. After a 10 hour start-up period, the FreeStyle Navigator Continuous Glucose Monitoring System is calibrated with a fingerstick measurement taken by a built-in glucose meter. After calibration, the FreeStyle Navigator System provides continuous glucose readings and updated glucose trend information for viewing. The FreeStyle Navigator Continuous Glucose Monitoring System also contains a built-in alarm that can be programmed to alert the user when results fall below pre-set low and pre-set high levels, and another alarm to alert users before their results reach pre-set levels.

When is it used? The FreeStyle Navigator Continuous Glucose Monitoring System is used with fingerstick measurements to provide additional glucose information to adults with diabetes, age 18 and over, and their healthcare practitioners. The Indications for Use are:

The FreeStyle Navigator Continuous Glucose Monitoring System is indicated for continually recording interstitial fluid glucose levels in people (ages 18 and older) with diabetes mellitus for the purpose of improving diabetes management. Readings and alarms about glucose levels from the FreeStyle Navigator Continuous Glucose Monitoring System are not intended to replace traditional blood glucose monitoring. Before adjusting therapy for diabetes management based on the results and alarms from the FreeStyle Navigator Continuous Glucose Monitoring System, traditional blood glucose tests must be performed. The FreeStyle Navigator Continuous Glucose Monitoring System provides a built-in blood glucose meter to confirm the continuous glucose result.

The FreeStyle Navigator Continuous Glucose Monitoring System provides real-time readings, graphs, trends and glucose alarms directly to the user. The FreeStyle Navigator Continuous Glucose Monitoring System is intended to be used in home settings to aid people with diabetes in predicting and detecting episodes of hypoglycemia and hyperglycemia and in clinical settings to aid healthcare professionals in evaluating glucose control. The FreeStyle Navigator Continuous Glucose Monitoring System is available only by prescription.

What will it accomplish? Additional glucose information may help people with diabetes and their healthcare practitioners to better manage their disease by providing more information on glucose trends and patterns than can be obtained with fingerstick glucose measurements alone.

When should it not be used?

• Results from this device are not designed to replace blood glucose meter measurements.
• Treatment decisions should not be based solely on results from the FreeStyle Navigator Continuous Glucose Monitoring System. You must confirm with a blood glucose meter measurement before making therapeutic adjustments.
• Symptoms related to low or high blood glucose levels should not be ignored. If you have symptoms of low or high glucose, use your blood glucose meter to check the FreeStayle Navigator System results.

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf5/p050020.html

Diabetes Information:
http://www.nlm.nih.gov/medlineplus/diabetes.html

Interactive Tutorial on Diabetes (requires Flash plug-in): http://www.nlm.nih.gov/medlineplus/tutorials/diabetesintroduction/htm/index.htm

tag: FDA Approval, Medical Devices, FreeStyle Navigator® Continuous Glucose Monitoring System