Nanowear gains FDA approval for first-of-its-kind wearable: undergarment that tracks cardiac health
NEW YORK — Nanowear, an early stage developer of cloth-based diagnostic monitoring nanosensor technology, on Thursday announced that it has received FDA Class II 510(k) clearance for its first product, SimplECG, a remote cardiac monitoring undergarment.
SimplECG collects continuous multi-channel ECG, heart rate and respiratory rate data from the garment and transfers it to a web-based portal for review by a physician, by way of a mobile application. The initial version of the product is iPhone-based.
"This is a big milestone for our young company," stated Venk Varadan, CEO Nanowear. "The FDA's decision not only positions us for commercial opportunities in remote cardiac monitoring, but more importantly, it provides accreditation of the company's one-of-a-kind, cloth-based sensor technology as medical-grade," he said. "This is the first step and foundation of what we believe to be an extensive array of applications for our nanosensor technology – including numerous other electrical, biometric and biochemical signals that can be measured directly from the skin without conductive gels, adhesives or skin preparation. The market of applications for healthcare alone is a multi-billion-dollar opportunity, but as we look beyond to consumer, industrial, clinical research, military and public sector applications, the addressable market expands exponentially."
This marks the company's first FDA clearance, and reflects Nanowear's strategy of differentiating itself in an otherwise crowded market for wearables, with an eye towards the future of the "Connected Self." SimplECG will provide an easier and more patient-friendly means of capturing and transmitting diagnostic data via everyday garments in an effort to monitor heart behavior and prevent cardiac-related events.
"As healthcare continues to evolve and move beyond the walls of the hospital, easy-to-use and clinically validated solutions are essential to ensure patient compliance and actionable diagnostic insights for physicians and providers," stated John Zimmerman, chief medical officer, Nanowear.
The company has worked in partnership with the FDA since early 2015 to understand the unique dynamics of this device, specifically the nanosensor technology. "Our discussions were collaborative and interactive, culminating in this announcement," Varadan said.
Having spent the last two years focused solely on product development and the regulatory process, Nanowear will now focus its near-term efforts on product commercialization, strategic partnerships and continued development of complementary products and applications for chronic disease states.
DoSomething.org and Truth call on pharmacy to ban tobacco sales
NEW YORK — DoSomething.org and the tobacco prevention campaign Truth on Thursday teamed up for its "Take Back the Shelves" initiative, a campaign that asks young people to creatively use social media to demand that pharmacies remove tobacco from shelves.
Beginning Dec. 1 and through the end of the month, millennials are encouraged to sign up for the campaign at DoSomething.org/shelves where they will be asked to download a template and create artwork with items they want to see behind pharmacy checkout counters instead of tobacco products. Young people will then share their drawings on social media with #TakeBacktheShelves tagging a pharmacy to ask them to remove tobacco products from their shelves.
"Tobacco and pharmacies just don't mix," said Aria Finger, CEO at DoSomething.org. "In 2014, CVS Health stopped selling tobacco products and we hope that other pharmacies will follow their lead and listen to young people. We are working with Truth in asking pharmacies to remove tobacco products altogether because we believe this can be the generation to end smoking for good."
Kira Kosarin, the 19-year-old star of Nickelodeon's "The Thundermans" recorded the public service announcement above to encourage fans to join the effort and show pharmacies what they want to see on the shelves instead of tobacco products.
"Smoking is the leading cause of preventable death in the U.S. and that's why I'm proud to join the movement to end smoking. I want to do anything I can to inform and keep my generation from starting to smoke in the first place," Kosarin said.
"At Truth, we never shy away from speaking out about the tactics used and products sold by Big Tobacco – this campaign with DoSomething.org is no different," said Eric Asche, chief marketing officer, Truth Initiative, the organization that runs truth. "The power to create social change is in the hands of today's young people. We know that creativity and social influence are tools that we can use to encourage pharmacies to remove tobacco products; a decision that is truly in the best interest of the consumer. We invite all pharmacies to join the Finish It movement to end smoking and the deadly impact it has on society."
While the teen cigarette smoking rate is 7% – an all-time low – Truth and DoSomething.org are building on this momentum and rallying a new generation to finish smoking for good. By encouraging young people to use their creativity, they are building the generation to '#FinishIT.'
CRN CEO named to U.S. Chamber of Commerce’s Association Committee of 100
WASHINGTON — Steve Mister, president and CEO of the Council for Responsible Nutrition, has been named to the U.S. Chamber of Commerce’s Association Committee of 100 (C100). For more than 50 years, leading association executives have gathered under the banner of the U.S. Chamber’s C100 to network, build partnerships, discuss current issues and represent the association community before the U.S. Chamber’s Board of Directors.
“The Chamber’s Committee of 100 has a long-standing reputation as one of the most prestigious appointments in the association community,” stated Rob Engstrom, SVP political affairs and federation relations at the U.S. Chamber.
Mister is one of six new members recently welcomed to the C100. According to Mister, the C100 provides CRN with new opportunities to collaborate in the Chamber’s lobbying and coalition work, to recommend programming, and to strengthen its outreach to the business and association communities. “I’m honored by this appointment and look forward to representing our member companies’ and our industry’s interests,” Mister said.
Mister has been president and CEO of CRN, a leading trade association for the dietary supplement industry, since 2005. Under his leadership, CRN has experienced substantial increases in membership and revenue, sharpened its strategic focus on dietary supplements and functional foods, and launched a number of initiatives that center on increasing industry responsibility, cultivating CRN’s reputation for thoughtful, credible and respected advocacy, and developing consumer education programming.