Capsule’s patient monitoring system clears the FDA

Capsule SmartLinx Vitals Plus

Qualcomm Life-owned Capsule has received FDA 510(k) clearance for SmartLinx Vitals Plus, a patient monitoring system that integrates vital signs monitoring and clinical documentation into one scalable platform. Part of Capsule’s SmartLinx Medical Device Information System, SmartLinx Vitals Plus is an alternative to traditional low acuity monitors, allowing 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 Neuron 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.”

SmartLinx Vitals Plus offers a compelling alternative to conventional monitoring that typically also requires a connectivity solution to automate charting and integration with the hospital electronic medical record. In that sense — and propelled with this FDA clearance — SmartLinx Vitals Plus wows to create a new product category for health care organizations that are converging their IT and biomed/clinical engineering organizations.

The company is planning limited deployment of its solution to key customers throughout the fourth quarter of 2015, with wider distribution beginning next year.