HEALTH

Nordic Naturals expands Omega Boost Junior line

BY Michael Johnsen

WATSONVILLE, Calif. – Nordic Naturals recently introduced its Omega Boost Junior in a paradise punch flavor in support of brain and eye health and healthy immune and nervous system function in children two years and older. A half-teaspoon serving offers 285 mg of omega-3s.
 
Like all Nordic Naturals omega-3 products, Omega Boost Junior surpasses the strictest international standards for purity, freshness, and quality. Its creamy emulsion formulation, paired with the triglyceride molecular form that Nordic Naturals insists on for its products, means fast absorption of essential omega-3s. Omega Boost Junior is kid-friendly with no gluten, corn, dairy, yeast, GMOs, or artificial colors or flavors.
 
“We have always been committed to making products that taste great so that people want to take them," stated Joar Opheim, Nordic Naturals CEO. "This is particularly important with products for children. Omega Boost Junior is not only delicious, it has a creamy consistency that kids like. It also offers meaningful levels of omega-3s, which parents will appreciate.”
 
Omega Boost Junior is the newest member of the Omega Boost family of products. Omega Boost is also available in creamy lemon and tropical mango flavors. Formulated with families in mind, the Omega Boost line offers a product for everyone.
 
Based in Watsonville, CA, Nordic Naturals is committed to delivering the world’s safest, most effective omega oils to help further its mission of correcting the global omega-3 deficiency. Distributing to more than 35 countries, Nordic Naturals offers over 200 products in a variety of flavors and formulations for adults, kids, athletes, and pets. As the number one fish oil in the United States, Nordic Naturals has revolutionized omega-3s, pioneering a new definition of fish oil quality as it relates to purity, freshness, taste, and dosage. Further information is available at www.nordicnaturals.com.
 
 
 
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FDA to review homeopathy regulations in April meeting

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration will be hosting a public hearing on the current use of homeopathic medicines, as well as the agency’s regulatory framework for such products, on April 20 and 21.
 
The FDA will be evaluating both prescription homeopathic remedies and over-the-counter solutions. 
 
The agency is looking to explore attitudes toward homeopathic remedies from both consumers and healthcare providers, as well as explore a regulatory framework that can better assess the risks and benefits associated with these medicines. The agency also will consider regulatory frameworks from other countries. 
 
The agency will use the forum to examine whether some of the uses indicated for homeopathic remedies are appropriate for the OTC arena. For example, the agency two weeks ago issued a warning to consumers to avoid use of over-the-counter asthma products labeled as homeopathic as "the products have not been evaluated for safety and effectiveness."
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AirStrip gets FDA clearance for its self-administered non-stress tests for prenatal care

BY Michael Johnsen

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.
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