EXTENSION, INC. Submits Context-Aware Communication Tool for FDA Product Clearance and Seeks a New Device Classification
HealthAlert for Nurses: forging a new path for FDA guidance on clinical alerting and communication tools
FORT WAYNE, Ind. — January 26, 2011 — (BUSINESS WIRE) — EXTENSION, INC. announced that it has recently submitted its HealthAlert™ for Nurses solution to the FDA for product clearance. The solution delivers critical alerts to a nurses Cisco IP handset, or preferred smartphone device whenever, wherever. According to the FDA’s response to EXTENSION’s original inquiry there is no communications tool on the market that is “substantially equivalent” to HealthAlert for Nurses.
EXTENSION’s submission for 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.
According to Todd Plesko, CEO of EXTENSION, “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.”
As hospitals and medical practices begin to implement electronic health records (EHRs), more medical devices and software applications will seek to utilize this information in conjunction with treatment decisions and enhanced communications capabilities – a development that will inevitably draw the attention of the FDA. EXTENSION strives to ensure its products comply with good manufacturing practices and is leading the market in defining the regulatory landscape.
EXTENSION is also a member of 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 MRC is developing a guidance document that will outline industry-wide concerns and propose solutions to the FDA relating to the regulatory oversight of mHealth products.
About EXTENSION, INC.
EXTENSION, INC. is the developer of the patent-pending EXTENSION® Solution Suite (ESS). The EXTENSION suite of software expands Cisco Unified Communications (UC) components and smartphones into critical workflow tools automating notifications using all modern messaging platforms, including Cisco’s award-winning IP phones. EXTENSION integrates any HL7-based application with Cisco Advanced UC using standards-based protocols. EXTENSION has earned the AHA’s exclusive endorsement for its HealthID™ patient smart card solution and has recently earned the ‘Cisco Collaboration Partner of the Year for the US/Canada.’ For more on EXTENSION visit http://www.opentheredbox.com. Visit the Apple AppStore to download a free demo of EXTENSION Mobile for HealthAlert for Nurses and HealthAlert for Physicians.
EXTENSION will showcase its solution suite at the HIMSS11 annual conference in February. Demonstrations in EXTENSION’s booth #1773 can be pre-scheduled by visiting http://www.opentheredbox.com/events_HIMSS11.php.