MiraDry
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MiraDry
miraDry is a microwave-based medical device developed by Miramar Labs which is used in the treatment of axillary hyperhidrosis. It was approved by the US Food and Drug Administration (FDA) in 2011 and was also approved in Europe. miraDry selectively destroys axillary sweat glands without affecting the superficial layers of the skin. In addition to sweat glands, miraDry destroys hair follicles in the axillary region regardless of hair color. It is about 72.5 to 90% effective and sweat is reduced by about 82% on average. It also reduces axillary hair by about 75%.https://corp.miradry.com/wp-content/uploads/2023/03/LB0322.D-MD4000-MC-User-Manual-freshConnect.pdf The effects of miraDry are noticeable almost immediately and are long-lasting or permanent. A case of death due to miraDry caused by necrotizing fasciitis Necrotizing fasciitis (NF), also known as flesh-eating disease, is an infection that kills the body's soft tissue. It is a serious disease that begins and spreads quickl ...
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Axillary Hyperhidrosis
Hyperhidrosis is a medical condition in which a person exhibits excessive sweating, more than is required for the regulation of body temperature. Although it is primarily a physical burden, hyperhidrosis can deteriorate the quality of life of the people who are affected, frequently leading to psychological, physical, and social consequences. Hyperhidrosis can lead to difficulties in professional fields, with more than 80% of patients experiencing moderate to severe emotional effects from the disease. This excess of sweat happens even if the person is not engaging in tasks that require muscular effort, and it does not depend on the exposure to heat. Common places to sweat can include underarms, face, neck, back, groin, feet, and hands. It has been called by some researchers 'the silent handicap'. Both ''diaphoresis'' and ''hidrosis'' can mean either ''perspiration'' (in which sense they are synonymous with ''sweating'') or ''excessive perspiration'', in which case they refer to a ...
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Microwave
Microwave is a form of electromagnetic radiation with wavelengths shorter than other radio waves but longer than infrared waves. Its wavelength ranges from about one meter to one millimeter, corresponding to frequency, frequencies between 300 MHz and 300 GHz, broadly construed. A more common definition in radio-frequency engineering is the range between 1 and 100 GHz (wavelengths between 30 cm and 3 mm), or between 1 and 3000 GHz (30 cm and 0.1 mm). In all cases, microwaves include the entire super high frequency, super high frequency (SHF) band (3 to 30 GHz, or 10 to 1 cm) at minimum. The boundaries between far infrared, terahertz radiation, microwaves, and ultra-high-frequency (UHF) are fairly arbitrary and differ between different fields of study. The prefix ' in ''microwave'' indicates that microwaves are small (having shorter wavelengths), compared to the radio waves used in prior radio technology. Frequencies in the micr ...
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Medical Device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of Archaeology, archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it was not until the Federal Food, Drug, and Cosmetic Act ( ...
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Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is ...
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Europe
Europe is a continent located entirely in the Northern Hemisphere and mostly in the Eastern Hemisphere. It is bordered by the Arctic Ocean to the north, the Atlantic Ocean to the west, the Mediterranean Sea to the south, and Asia to the east. Europe shares the landmass of Eurasia with Asia, and of Afro-Eurasia with both Africa and Asia. Europe is commonly considered to be Boundaries between the continents#Asia and Europe, separated from Asia by the Drainage divide, watershed of the Ural Mountains, the Ural (river), Ural River, the Caspian Sea, the Greater Caucasus, the Black Sea, and the waterway of the Bosporus, Bosporus Strait. "Europe" (pp. 68–69); "Asia" (pp. 90–91): "A commonly accepted division between Asia and Europe ... is formed by the Ural Mountains, Ural River, Caspian Sea, Caucasus Mountains, and the Black Sea with its outlets, the Bosporus and Dardanelles." Europe covers approx. , or 2% of Earth#Surface, Earth's surface (6.8% of Earth's land area), making it ...
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Axilla
The axilla (: axillae or axillas; also known as the armpit, underarm or oxter) is the area on the human body directly under the shoulder joint. It includes the axillary space, an anatomical space within the shoulder girdle between the arm and the thoracic cage, bounded superiorly by the imaginary plane between the superior borders of the first rib, clavicle and scapula (above which are considered part of the neck), medially by the serratus anterior muscle and thoracolumbar fascia, anteriorly by the pectoral muscles and posteriorly by the subscapularis, teres major and latissimus dorsi muscle. The soft skin covering the lateral axilla contains many hair and sweat glands. In humans, the formation of body odor happens mostly in the axilla. These odorant substances have been suggested by some to serve as pheromones, which play a role related to mate selection, although this is a controversial topic within the scientific community. The underarms seem more importa ...
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Sweat Gland
Sweat glands, also known as sudoriferous or sudoriparous glands, , are small tubular structures of the skin that produce sweat. Sweat glands are a type of exocrine gland, which are glands that produce and secrete substances onto an epithelial surface by way of a duct. There are two main types of sweat glands that differ in their structure, function, secretory product, mechanism of excretion, anatomic distribution, and distribution across species: * Eccrine sweat glands are distributed almost all over the human body, in varying densities, with the highest density in palms and soles, then on the head, but much less on the trunk and the extremities. Their water-based secretion represents a primary form of cooling in humans. * Apocrine sweat glands are mostly limited to the axillae (armpits) and perineal area in humans. They are not significant for cooling in humans, but are the sole effective sweat glands in hoofed animals, such as the camels, donkeys, horses, and cattle. Ceru ...
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Hair Follicle
The hair follicle is an organ found in mammalian skin. It resides in the dermal layer of the skin and is made up of 20 different cell types, each with distinct functions. The hair follicle regulates hair growth via a complex interaction between hormones, neuropeptides, and immune cells. This complex interaction induces the hair follicle to produce different types of hair as seen on different parts of the body. For example, terminal hairs grow on the scalp and lanugo hairs are seen covering the bodies of fetuses in the uterus and in some newborn babies. The process of hair growth occurs in distinct sequential stages: ''anagen'' is the active growth phase, ''catagen'' is the regression of the hair follicle phase, ''telogen'' is the resting stage, ''exogen'' is the active shedding of hair phase and ''kenogen'' is the phase between the empty hair follicle and the growth of new hair. The function of hair in humans has long been a subject of interest and continues to be an impor ...
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Hair Color
Human hair color is the pigmentation of human hair follicles and shafts due to two types of melanin: eumelanin and pheomelanin. Generally, the more melanin present, the darker the hair. Its tone depends on the ratio of black or brown eumelanin to yellow or red pheomelanin. Melanin levels can vary over time, causing a person's hair color to change, and one person can have hair follicles of more than one color. Some hair colors are associated with some ethnic groups because of the observed higher frequency of particular hair colors within their geographical region, e.g. straight, dark hair amongst East Asians, Southeast Asians, Polynesians, some Central Asians, and Native Americans; a large variety of dark, fair, curly, straight, wavy or bushy amongst Europeans, West Asians, some Central Asians, and North Africans; and curly, dark, and uniquely helical hair amongst Sub Saharan Africans. Bright red hair is found in some European populations, and hair turns gray, white ...
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Necrotizing Fasciitis
Necrotizing fasciitis (NF), also known as flesh-eating disease, is an infection that kills the body's soft tissue. It is a serious disease that begins and spreads quickly. Symptoms include red or purple or black skin, swelling, severe pain, fever, and vomiting. The most commonly affected areas are the limb (anatomy), limbs and perineum. Bacterial infection is by far the most common cause of necrotizing fasciitis. Despite being called a "flesh-eating disease", bacteria do not eat human tissue. Rather, they release toxins that cause tissue death. Typically, the infection enters the body through a break in the skin such as a cut or burn. Risk factors include recent trauma or surgery and immunodeficiency, a weakened immune system due to diabetes or cancer, obesity, alcoholism, intravenous drug use, and peripheral artery disease. It does not usually spread between people. The disease is classified into four types, depending on the infecting organisms. Medical imaging is often helpfu ...
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Streptococcal Toxic Shock Syndrome
''Streptococcus'' is a genus of gram-positive spherical bacteria that belongs to the family Streptococcaceae, within the order Lactobacillales (lactic acid bacteria), in the phylum Bacillota. Cell division in streptococci occurs along a single axis, thus when growing they tend to form pairs or chains, which may appear bent or twisted. This differs from staphylococci, which divide along multiple axes, thereby generating irregular, grape-like clusters of cells. Most streptococci are oxidase-negative and catalase-negative, and many are facultative anaerobes (capable of growth both aerobically and anaerobically). The term was coined in 1877 by Viennese surgeon Albert Theodor Billroth (1829–1894), by combining the prefix "strepto-" (from ), together with the suffix "-coccus" (from Modern , from .) In 1984, many bacteria formerly grouped in the genus ''Streptococcus'' were separated out into the genera ''Enterococcus'' and ''Lactococcus''. Currently, over 50 species are recogni ...
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Medical Devices
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of Archaeology, archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it was not until the Federal Food, Drug, and Cosmetic Act ( ...
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