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In a first for Apple, FDA clears EKG device for Apple Watch

BY Michael Johnsen

Mountain View, Calif.-based AliveCor on Thursday announced FDA clearance of KardiaBand in the U.S., allowing Apple Watch users to discreetly capture their EKG anytime, anywhere in order to quickly detect normal sinus heart rhythms and atrial fibrillation, the most common heart arrhythmia.

The first FDA-cleared medical device accessory for Apple Watch, KardiaBand can record an EKG in 30 seconds with just a touch of its integrated sensor. Results from the Kardia App are displayed on the face of Apple Watch.

"KardiaBand paired with SmartRhythm technology will be life-changing for people who are serious about heart health," stated Vic Gundotra, CEO, AliveCor. "These capabilities will allow people to easily and discreetly check their heart rhythms when they may be abnormal, capturing essential information to help doctors identify the issue and inform a clear path of care to help manage AFib, a leading cause of stroke, and other serious conditions."

AliveCor is also introducing SmartRhythm, a new feature within the Kardia app for Apple Watch. SmartRhythm uses artificial intelligence in concert with inputs from Apple Watch's heart rate and activity sensors to continuously evaluate the correlation between heart activity and physical activity. When SmartRhythm detects that heart rate and activity are out of sync, the device notifies users to capture an EKG with KardiaBand, or with KardiaMobile, AliveCor's popular, portable EKG reader.

Atrial Fibrillation, is the most common heart arrhythmia, and a leading cause of stroke. AFib affects more than 30 million people worldwide, and one in four people over the age of 40 are at risk for developing it. Millions of people around the world are unknowingly living with AFib. Yet, two out of three strokes are preventable when AFib is detected and treated appropriately.

"This is a paradigm shift for cardiac care as well as an important advance in healthcare," said Ronald Karlsberg, cardiologist and clinical professor of medicine, Cedars Sinai Heart Institute and David Geffen School of Medicine UCLA. "Today, EKGs are available only in offices and hospitals, using complex equipment, and usually only after a life threatening event, for example a stroke. With an EKG device on the wrist, AFib can be detected wherever the patient is, 24 hours a day. In randomized research trials, KardiaMobile, the first AliveCor EKG device, proved to be superior to routine care provided by physicians. Today, KardiaBand is a giant leap in personalized health care."

As a medtech leader, AliveCor uses advanced artificial intelligence, mobile, cloud and micro-electrode technology to change the dynamic in cardiac care. AliveCor empowers people worldwide to proactively manage heart health and to vastly improve the quality of care in the fight against heart disease. AliveCor's KardiaMobile and KardiaBand enable people and their care teams to easily, quickly and inexpensively detect and manage possible abnormal heart rhythms.

KardiaBand is available starting today for $199 and requires subscription to AliveCor's Premium service for $99 a year. The combined system includes SmartRhythm notifications on Apple Watch; unlimited EKG recordings; automatic detection of Atrial Fibrillation or normal sinus rhythm; the unlimited ability to send EKG readings to anyone via email; unlimited cloud history and reporting of all EKGs ever taken; weight and medication tracking; and a mailed monthly paper report on readings taken each calendar month.

 

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NIH maps indoor allergens prevelance nationwide

BY Michael Johnsen

Allergens are widespread, but highly variable in U.S. homes, according to the nation’s largest indoor allergen study to date. Researchers from the National Institutes of Health on Thursday reported that more than 90% of homes had three or more detectable allergens, and 73% of homes had at least one allergen at elevated levels.

“Elevated allergen levels can exacerbate symptoms in people who suffer from asthma and allergies, so it is crucial to understand the factors that contribute,” stated Darryl Zeldin, senior author and scientific director at the National Institute of Environmental Health Sciences, which is part of NIH.

Using data from the 2005-2006 National Health and Nutrition Examination Survey (NHANES), the researchers studied levels of eight common allergens – cat, dog, cockroach, mouse, rat, mold, and two types of dust mite allergens – in the bedrooms of nearly 7,000 U.S. homes.

They found that the presence of pets and pests had a major influence on high levels of indoor allergens. Housing characteristics also mattered – elevated exposure to multiple allergens was more likely in mobile homes, older homes, rental homes, and homes in rural areas.

The findings were published November 30 in the Journal of Allergy and Clinical Immunology.

For individual allergens, exposure levels varied greatly with age, sex, race, ethnicity and socioeconomic status. Differences were also found between geographic locations and climatic conditions. For example, elevated dust mite allergen levels were more common in the South and Northeast, and in regions with a humid climate. Levels of cat and dust mite allergens were also found to be higher in rural areas than in urban settings.

 

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Tena improves incontinence line with new breathable technology

BY Michael Johnsen

Philadelphia-based Tena on Thursday announced its Premium Briefs, Protective Underwear and Heavy Pad incontinence products will now feature Tena ConfioAir 100% breathable technology, which allows excess moisture to evaporate, to help maintain skin's natural moisture balance and improve comfort for wearers.

"We look beyond the product to focus on the individuals, and are dedicated to finding new solutions that offer optimum fit and functionality while improving quality of care," stated Jessica Lan, director product management for Essity Health and Medical Solutions, North America, which manufactures the products. "With this upgrade to our absorbent line, we are pleased to provide more options that help maintain a care routine and lead to better skin health."

"Tena ConfioAir 100% breathable technology is unlike any other innovation in the field of adult incontinence," noted Tony Forsberg, national clinical director for Essity Health and Medical Solutions, North America. "While almost every other product has breathable materials from the front to back of the brief, with ConfioAir we can now keep moisture away from the skin and protect it with a whole vapor- and heat- permeable product."

Tena's ConfioAir technology features a unique outer layer with micro-pores that allows moisture from the inner absorbent core to evaporate. This helps maintain skin's natural moisture balance, allowing it to breathe and keeping the skin on the inside of the product comfortable and dry. This technology is now included across Tena's premium absorbent product line at no additional cost to the customer.

For the large population that suffers from incontinence, discomfort can happen quickly. Many incontinent individuals are elderly and have fragile skin that faces a variety of threats including skin ulcers, incontinence-associated dermatitis and infection as well as greater potential for injury as healing slows down. Recognizing that skin health is important for incontinent individuals, who are at risk of painful irritations from prolonged exposure to moisture, it is vital to provide comfort and care to the perineal area and support the overall quality of life for product users.

 

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