Qualcomm’s Capsule Receives FDA Clearance of SmartLinx Vitals Plus

Launches innovative new product to integrate vital signs monitoring, documentation and connectivity in a single device

Qualcomm Incorporated has announced that Capsule, a wholly owned subsidiary of Qualcomm Life, Inc., has received FDA 510(k) clearance of SmartLinx Vitals Plus, an innovative patient monitoring system that uniquely integrates vital signs monitoring and clinical documentation into one scalable platform. SmartLinx Vitals Plus, part of Capsule’s SmartLinx Medical Device Information System™, is a powerful alternative to traditional low acuity monitors. It provides new functionality in a single platform that allows hospitals and other health care facilities to streamline user authentication, patient identification, vitals measurement, and clinical documentation by integrating vital signs modules and components directly to the SmartLinx NeuronTM 2 mobile clinical computer.

“Today’s patient bedside is crowded with technology used to capture, chart and review the complete set of patient vitals, and we see tremendous opportunity in technological convergence – the ability to combine these multiple components into a single device or ‘all-in-one’ solution requiring one workflow,” said Kevin Phillips, vice president, marketing and product management, Capsule. “In SmartLinx Vitals Plus, we developed a fully integrated mobile system that streamlines the patient monitoring and clinical documentation process through a clinician-friendly, flexible workflow – complete with an early warning scoring system – that presents vitals data all on one screen, right at the point-of-care.”

As health care facilities retire older vital signs monitors, SmartLinx Vitals Plus offers a compelling alternative to conventional monitoring, which typically also requires a connectivity solution to automate charting and integration with the hospital electronic medical record. SmartLinx Vitals Plus transforms a clinical IT device into a biomedical device to create a new product category for health care organizations that are converging their IT and biomed/clinical engineering organizations.

“SmartLinx Vitals Plus has the potential to deliver more patient data to the medical record with timeliness and accuracy.” said Capsule client Lisa Levine, MSN, BSN, RN-BC, supervisor, clinical systems, Memorial Healthcare System in Miramar, FL. “The workflow was designed with the clinician in mind, allowing for increased efficiency. IT will re-use the existing SmartLinx MDIS infrastructure for management and connectivity, making it an easy transition to use SmartLinx Vitals Plus.”

The Company is planning limited deployment of SmartLinx Vitals Plus to key customers throughout the fourth quarter of 2015, with wider distribution beginning in 2016.
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