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Extension submits HealthAlert for Class III Medical Device clearance

Extension has submitted HealthAlert for Nurses solution to the US Food and Drug Administration (FDA) for Class III Medical Device clearance.

The solution delivers critical alerts to a nurses Cisco IP handset, or preferred smartphone device.

Extension’s submission voluntarily subjects HealthAlert for Nurses to the FDA’s highest level of Quality System (QS) Regulation and Medical Device Good Manufacturing Practices.

Extension CEO Todd Plesko said this submission for FDA clearance culminates two years of research and 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," Plesko said.

Extension said more medical devices and software applications will seek to utilize the information in conjunction with treatment decisions and enhanced communications capabilities, as hospitals and medical practices begin to implement electronic health records (EHRs).