AirStrip gets FDA clearance for its self-administered non-stress tests for prenatal care
SAN ANTONIO — The Food and Drug Administration on Wednesday cleared the AirStrip Sense4Baby wireless maternal/fetal monitoring system to be marketed for use in the United States by pregnant patients to self-administer non-stress tests.
Sense4Baby already received 510(k) clearance from the FDA for use accompanied by medical professionals. Sense4Baby also received the CE mark from the European Commission in 2013 for self-administration, including the home.
This new clearance is an important step toward integrating out-of-hospital perinatal monitoring data into the AirStrip ONE interoperable mobility platform and application. AirStrip ONE provides vendor- and data source-agnostic information from multiple data sources and care settings to support coordination among caregivers natively on smartphones, tablets and personal computers.
"AirStrip Sense4Baby can supplement care for patients with a prescribed need for NSTs that — with proper training and a care team's interpretation of data — offers a safe, convenient and cost-effective monitoring method in settings beyond hospital walls," said Matt Patterson, AirStrip president. "Sense4Baby is a natural extension of AirStrip ONE, creating a new avenue for seamless mobile monitoring that can connect patients with their care team while encouraging true patient engagement and peace of mind."
The University of Utah will conduct a research study to test AirStrip Sense4Baby in a local high-risk population. The goal is to assess the feasibility of integrating an at-home NST monitoring program into an established health care system, as well as to evaluate patient and provider satisfaction.
The University of Utah aims to show that mobile connectivity can positively impact prenatal care for both low- and high-risk pregnancies. Currently, NSTs are typically conducted in clinics or hospitals.
"Patients may need to travel for extended periods of time, multiple times per week, in order to receive these tests," said Erin Clark, assistant professor of maternal/fetal medicine in the Department of Obstetrics and Gynecology at Utah. "At-home fetal monitoring may allow patients to save time and money related to travel for NSTs, and may also increase the capacity and flexibility of health systems to conduct NSTs. The University of Utah strives to provide the very best prenatal care to our patients, with the highest patient satisfaction, at the lowest cost to patients and to the healthcare system. Strategies that employ mobile connectivity may be a key part of this vision."
The FDA clearance is the latest in a series of announcements since AirStrip acquired the assets of Sense4Baby in 2014. In February, AirStrip announced agreements to launch Sense4Baby in Europe, Africa and Australia/New Zealand. More international expansion announcements are expected soon.
Hi-Tech Pharmaceuticals launches Fastin Rapid Release diet aid
NORCROSS, Ga. — Hi-Tech Pharmaceuticals is launching its Fastin Rapid Release diet aid beyond its exclusive debut with Rite Aid, the company announced Tuesday.
Hi-Tech has initiated a multi-million dollar advertising campaign to support the launch.
"The nationwide launch of Fastin Rapid Release is an important development for men and women who struggle with being overweight with and need help with weight management beyond diet and exercise," stated Jared Wheat, Hi-Tech's president and CEO. "Fastin Rapid Release really is the pre-eminent diet aid on the market right now because, unlike most of the weight-loss supplements, on the market, it actually has two product-specific studies that provide evidence of efficacy. One study was conducted on Fastin Rapid Release and its effects on the metabolic rate. The second study was an eight-week weight loss and fat loss study that showed it caused people to lose 208% more weight and 385% more fat than placebo."
Fastin Rapid Release is made with "Explotab technology" for an immediate burst of the active ingredients, providing rapid onset of energy and thermogenesis, the company stated.
New dry mouth solution Salese hits market
SANTA CLARA, Calif. — Nuvora on Monday announced a solution for dry mouth called Salese.
“The duration of existing lozenge treatments is too short to be effective. For truly effective treatment of oral care issues and relief arising from dry mouth, you have to have the right ingredients and literally bathe the tissues in the mouth over a sustained period of time," stated Jerry Gin, Nuvora CEO. "Most oral care products remain in the mouth for only a very brief time and are then swallowed or spit out, ending up where they don’t really do much good.”
Salese uses a patented sustained release drug delivery technology that provides continuous relief from dry mouth, Gin said. The lozenges last significantly longer than typical treatments, offering hours of dry mouth relief by restoring a moist mouth feel, while treating the oral cavity with a controlled release of substantially lower therapeutic doses of natural active ingredients.
“When dry mouth happens, then there’s not enough saliva to wash away bacteria, and this can trigger bad breath and a cascade of oral health problems – cavities, gingivitis and periodontitis, on top of other health issues,” Gin said. “These natural ingredients in Salese, in addition to offering relief for dry mouth, promote oral health by killing plaque bacteria with xylitol and essential oils, neutralize acids from bacteria that cause cavities, and freshen breath by using zinc to capture volatile sulfur compounds from bacteria that cause bad breath (halitosis).”
According to the company, as many as 70 million Americans suffer from dry mouth and 75% of prescription drugs (approximately 1,800 medications) cause it.
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