Qualcomm’s Capsule wins FDA nod for patient monitoring system

Qualcomm (NASDAQ: QCOM) medical data management subsidiary Capsule Tech said it received FDA 510(k) clearance for its SmartLinx Vitals Plus patient monitoring system.

The SmartLinx system integrates remote monitoring of patient vital signs and clinical patient documentation into a single platform as part of Capsule’s broader SmartLinx medical device information system.

“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. 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,” Capsule marketing and product management veep Kevin Phillips said in a press release.

The company said there will be a limited deployment of the newly cleared system throughout the 4th quarter of 2015 with wider distribution coming in 2016.

“SmartLinx Vitals Plus has the potential to deliver more patient data to the medical record with timeliness and accuracy. 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,” Capsule client Lisa Levine of Miramar, Fla.’s Memorial Healthcare System said in prepared remarks.

In September, Quallcomm said its subsidiary Qualcomm Life purchased Capsule for an undisclosed amount.

The San Diego, Calif.-based company said the acquisition will allow Qualcomm Life to expand from into hospitals, taking over Capsule’s 1,930 hospital clients in 38 countries.

“For Qualcomm Life, finding capsule as an established, well executed technology that’s already operating in 2,000 hospitals was really an exciting acquisition opportunity and fits so perfectly with the overall strategy of the internet of medical things,” Qualcomm Life chief medical officer Dr. James Mault told MassDevice.com in an interview.

The company put together an M&A strategy around creating an ‘internet of medical things’, Mault said.

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