Following on the heels of the reveal of an EXTENSION Mobile app for EXTENSION HealthAlert for Nurses and HealthAlert for Physicians, EXTENSION, Inc. has submitted it HealthAlert for Nurses solution to the FDA for product clearance.
Organizations can now download the EXTENSION Mobile app and demo for the iPhone and iPod Touch for free via the Apple AppStore, as well as be assured of its quality after FDA clearance. Class III Medical Device clearance voluntarily subjects HealthAlert for Nurses to the FDA's highest level of Quality System (QS) Regulation and Medical Device Good Manufacturing Practices and by extension, the highest possible standards available. Without making a substantial investment, organizations therefore will be able to get first-hand knowledge of the capabilities of the solutions. According to the FDA's response to EXTENSION's inquiry there is no communications tool on the market that is "substantially equivalent" to HealthAlert for Nurses.
HealthAlert for Nurses is a solution delivering critical alerts to a nurse’s Cisco IP handset or now with affordable bundled packages on Apple iPhone or iPod Touch, any preferred smartphone device. In a press release, Steve Tyler, CTO of EXTENSION, said, “The EXTENSION vision has always been about enabling context-aware communication on the users preferred device.”
Meeting preferences was a way of pleasing the customer, and acquiring FDA clearance is step in ensuring the customer. In a press release, Todd Plesko, CEO of EXTENSION, said, "This submission for FDA clearance culminates two years of research and tremendous effort designed to differentiate EXTENSION from similar - but certainly not equal products - currently available in the marketplace. It also offers comfort to our growing hospital client base seeking to utilize their existing Cisco infrastructure and/or the emergence of smartphones, and serves as future-proofing for our clients and partners in the face of more FDA regulation in the middleware communication space. I think everyone in the industry agrees more FDA regulation in mobile health and communication is on the horizon. We've positioned ourselves well ahead of the pack both for Cisco IP-based handsets and smartphones."
EXTENSION, INC. announced that it has joined the mHealth Regulatory Coalition (MRC), an organization comprised of industry stakeholders seeking to determine the quality and safety issues that are created when mobile health technologies combine to create a network of communications products and services. The partnership will assist with the development of a guidance document, which will outline industry-wide concerns and propose solutions to the FDA relating to the regulatory oversight of mHealth products.
Jaclyn Allard is a HealthTechZone copy editor. She most recently worked on the production team at Juran Institute, a quality consulting firm producing its own training and marketing materials. Previously, she interned at Curbstone Press, a nonprofit publishing press in Willimantic, CT, and fulfilled the role of Editor-in-Chief for the literature and arts journal published by the University of Connecticut. To read more of her articles, please visit her columnist page.Edited by
Jaclyn Allard
