Breaking News
March 24, 2019 - New nanotechnology approach shows promise in treating triple negative breast cancer
March 24, 2019 - Trevena Announces Publication of APOLLO-1 Results in The Journal of Pain Research Highlighting Oliceridine’s Potential for Management of Moderate-to-Severe Acute Pain
March 24, 2019 - Maternal deaths following C-section 50 times higher in Africa compared to high-income countries
March 24, 2019 - Apple watch could detect irregular heart beat says study
March 24, 2019 - Queen Mary University of London’s BCI boosts radionuclide imaging capabilities with MILabs VECTor technology
March 24, 2019 - Girls should be encouraged to gain more ball skills, shows study
March 24, 2019 - Acute doses of synthetic cannabinoid can impair critical thinking and memory
March 24, 2019 - Presence of bacteria in urine does not always point to infection, shows study
March 24, 2019 - Scientists identify a new role for nerve-supporting cells
March 24, 2019 - Hidden differences between pathology of CTE and Alzheimer’s disease discovered
March 24, 2019 - Knowing causative genes of osteoporosis may open door to more effective treatments
March 24, 2019 - Toilet-seat based cardiovascular monitoring system getting ready to begin commercialization
March 24, 2019 - New model for intensive care identifies factors that send ill patients to ICU
March 24, 2019 - Recommendations Issued for HSCT in Multiple Myeloma
March 24, 2019 - Deep brain stimulation provides sustained relief for severe depression
March 24, 2019 - “Statistical significance” may soon be a thing of past?
March 24, 2019 - Researchers track effects of epigenetic marks carried by sperm chromosomes
March 24, 2019 - AHA News: Family Adopts Three Children With Three Different Heart Conditions
March 24, 2019 - Research into opioid painkillers could provide clues for safer drug development
March 23, 2019 - Lung cancer survivor recounts her lifetime struggles
March 23, 2019 - Radial and femoral approach for PCI achieve similar results in terms of survival
March 23, 2019 - Study sheds light on the optimal timing of coronary angiography in NSTEMI patients
March 23, 2019 - Excess hormones could cause a condition that can lead to blindness in women, study finds
March 23, 2019 - Dramatic shifts in first-time opioid prescriptions bring hope, concern
March 23, 2019 - Antidepressant drugs may not work when neurons are out of shape
March 23, 2019 - TTUHSC El Paso to establish endowed chair in neurology through a major grant
March 23, 2019 - New device approved by FDA for treating patients with moderate-to-severe heart failure
March 23, 2019 - People with peripheral artery disease have lower Omega-3 Index, shows research
March 23, 2019 - Trigger warnings have minimal impact on how people respond to content, shows research
March 23, 2019 - Gilead Announces Data From Two Studies Supporting Further Development of GS-6207, a Novel, Investigational HIV-1 Capsid Inhibitor as a Component of Future Long-Acting HIV Therapies
March 23, 2019 - Selfish genetic elements amplify inflammation and age-related diseases
March 23, 2019 - Study provides new understanding of how the brain recovers from damage caused by stroke
March 23, 2019 - CRISPR/Cas libraries could revolutionize drug discovery
March 23, 2019 - Allergic reaction during pregnancy may alter sexual-development in offspring’s brain
March 23, 2019 - Seeing through a robot’s eyes helps those with profound motor impairments
March 23, 2019 - Recent research shows that ease of breastfeeding after C-section differs culturally
March 23, 2019 - Newly discovered parameters offer more control over efficient release of drugs
March 23, 2019 - ‘De-tabooing’ of abortion- Women would like more support from health care community
March 23, 2019 - Anti-TB drugs can increase susceptibility to Mtb reinfection
March 23, 2019 - New survey indicates need of attention to neglected tropical diseases
March 23, 2019 - Innovative in vitro method to develop easy-to-swallow medicine for children and older people
March 23, 2019 - Sugary drinks could raise risk of early deaths finds study
March 23, 2019 - Lian wins ENGINE grant for stem-cell-based therapy to treat Type 1 diabetes
March 23, 2019 - Overall, Physicians Are Happy and Enjoy Their Lives
March 23, 2019 - Researchers discover how blood vessels protect the brain during inflammation
March 23, 2019 - CDC study shows modest improvement in optimal hospital breastfeeding policy
March 23, 2019 - Family-based prevention program to reduce alcohol use among older teens
March 23, 2019 - Remote monitoring of implanted defibrillators in heart failure patients prevents hospitalizations
March 23, 2019 - Appropriate doffing of personal protective equipment may reduce healthcare worker contamination
March 23, 2019 - Window screens can suppress mosquito populations, reduce malaria in Tanzania
March 23, 2019 - Researchers discover new biomarker for postoperative liver dysfunction
March 23, 2019 - Pregnancy history may be linked to cognitive function in older women, finds study
March 23, 2019 - Study shows ticagrelor is equally safe and effective as clopidogrel after heart attack
March 23, 2019 - FDA Approves First Drug for Postpartum Depression, Zulresso (brexanolone)
March 23, 2019 - New guidelines outline new treatment management for psoriasis
March 23, 2019 - Thermally abused cooking oil may promote progression of breast cancer
March 23, 2019 - High-fructose corn syrup fuels growth of colon tumors in mice
March 23, 2019 - Partnership aims at establishing best practices to promote diversity in clinical trials
March 23, 2019 - New study examines presence of microbes in tap water from residences, office buildings
March 23, 2019 - Early life trauma may affect brain structure, contribute to major depressive disorder
March 23, 2019 - NIH starts clinical trial of drug to treat cravings associated with opioid use disorder
March 23, 2019 - Cervix bacteria, immune factors could be a warning signal of premature birth, reports new research
March 23, 2019 - Worst-ever emergency care performance figures underscore the need to focus on staffing
March 23, 2019 - The Current issue of “The view from here” is concerned with Cancer
March 23, 2019 - Mouse model validates how ‘good’ and ‘bad’ bacteria affect acne
March 23, 2019 - Individual amygdala neurons respond to touch, imagery and sounds
March 23, 2019 - Combination of two topical creams can prevent cancer
March 23, 2019 - Study suggests depression screening when assessing African-Americans for schizophrenia
March 23, 2019 - New electronic support system for choosing drug treatment based on patient’s genotype
March 23, 2019 - First-of-its-kind study provides pregnancy statistics of imprisoned U.S. women
March 23, 2019 - Marinus Pharmaceuticals Initiates Phase 3 Study in Children with PCDH19-Related Epilepsy
March 23, 2019 - Laparoscopy: MedlinePlus Lab Test Information
March 23, 2019 - Shellfish allergies: can they be treated?
March 23, 2019 - Toilet seat heart monitoring system
March 23, 2019 - Researchers identify way to improve common treatment for PTSD
March 23, 2019 - High potency cannabis use linked to psychosis finds study
March 23, 2019 - Evoke Pharma Submits Response to FDA Review Letter for Gimoti NDA
March 23, 2019 - Tracking HIV’s ever-evolving genome in effort to prioritize public health resources
March 23, 2019 - Scientists grow most sophisticated brain organoid to date
March 23, 2019 - ADHD drug raising risk of psychosis
FDA grants marketing authorization for new device to help treat carbon monoxide poisoning

FDA grants marketing authorization for new device to help treat carbon monoxide poisoning

image_pdfDownload PDFimage_print

The U.S. Food and Drug Administration today allowed marketing of a new device, ClearMate, intended to be used in an emergency room setting to help treat patients suffering from carbon monoxide poisoning. The device uses a novel method for quickly removing carbon monoxide from the body by increasing a patient’s rate of breathing.

“Carbon monoxide poisoning is a serious issue, affecting thousands of people each year,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices in the FDA’s Center for Devices and Radiological Health. “While the current standard treatment of administering 100 percent oxygen through a mask can be done anywhere, hyperbaric treatment, which is necessary for severe carbon monoxide poisoning, is less accessible because there are only 60 medical centers with hyperbaric units in the entire U.S. Moreover, those medical facilities are seldom in rural areas, so treatment in those areas could be delayed considerably due to transport time. Today’s marketing authorization provides patients with access to a simple, yet lifesaving device that may minimize the delay of getting vital treatment, especially in severe cases of carbon monoxide poisoning.”

Carbon monoxide is a colorless, odorless gas that is extremely poisonous and can kill within minutes. In the U.S. each year, nearly 500 people die while as many as 20,000 visit emergency rooms for unintended exposure to carbon monoxide, primarily from poorly-maintained heating systems, or gas stoves or gas-powered generators used for heat or power during storms. The most common symptoms of carbon monoxide poisoning are headache, dizziness, weakness, upset stomach, vomiting, chest pain and confusion. Carbon monoxide poisoning occurs when carbon monoxide attaches to the hemoglobin in the blood exactly where oxygen is supposed to attach, reducing the amount of oxygen carried to the brain and other tissues.

The standard form of treatment for carbon monoxide poisoning is to have the patient breathe 100 percent oxygen through a mask. In severe cases, a hyperbaric chamber may be used, which delivers oxygen under higher than normal pressure.

ClearMate-;a device consisting of a gas mixer, valves, meters, breathing circuits, an oxygen reservoir, a mask and hoses-;works by speeding up the elimination of carbon monoxide from the body. It delivers both 100 percent oxygen to the patient, as well as a mixture of oxygen and carbon dioxide, causing the patient to breathe faster. The increased breathing accelerates the rate at which the carbon monoxide leaves the patient’s body, allowing a normal amount of oxygen to attach to hemoglobin and be carried where it is needed throughout the body.

In authorizing marketing of ClearMate, the FDA reviewed data from multiple clinical studies, which tested the effectiveness of the device on 100 patients. The studies demonstrated the device was effective at eliminating carbon monoxide. The combination of oxygen and carbon dioxide in the ClearMate resulted in a faster elimination of carbon monoxide than treatment with 100 percent oxygen alone but was not faster than hyperbaric oxygen therapy.

Patients did not experience any device-related complications in the clinical studies of efficacy or in a separate study of the device’s safety.

ClearMate was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

The FDA granted marketing authorization of ClearMate to Thornhill Research, Inc.

Source:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633533.htm

Tagged with:

About author

Related Articles