FDA clears mobile vitals monitor from recent Qualcomm acquisition Capsule

By Jonah Comstock
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Vitals plus screenThe FDA has cleared SmartLinx Vitals Plus, a mobile-connected in-hospital patient monitoring system from Qualcomm Life subsidiary Capsule. It received FDA 510(k) clearance for prescription use as a class II medical device. Qualcomm Life completed the acquisition of the French company just last month.

On its website, Capsule describes Vitals Plus as "an innovative patient monitoring system that uniquely integrates vital signs monitoring, clinical documentation and connectivity into into a single device". It monitors blood pressure, pulse oximetry, pulse rate and temperature and calculates an early warning score based on those vitals. It's one of several different options in Capsule's SmartLinx line of in-hospital medical device connectivity systems, but unlike some of the others it employs a tablet form factor.

"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," Kevin Phillips, vice president of marketing and product management at Capsule, said in a statement. "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."

The company plans to roll out the system almost immediately, with "key customers" receiving it in Q4 2015 and wider distribution beginning next year.

Qualcomm Life's acquisition of Capsule last month, for an undisclosed amount, was notable because it broadened the scope of Qualcomm's healthcare presence from home health care to all remote monitoring connectivity, inside and outside the hospital.