FDA clears connected surveillance product Capsule Vitals Plus

By Laura Lovett
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The FDA has recently cleared a second generation of Qualcomm Life’s Capsule Vitals Plus, a connected monitoring product. Capsule Vitals Plus records medical device data and continuous vital signs monitoring. It then analyzes the information at the patient's bedside. 

“As a fundamentally connected monitor evolved from Capsule’s approach to connectivity and experience in nursing workflows, Vitals Plus improves the timeliness, accuracy, and completeness of bedside information,” Andy Wescott, senior global product manager, wrote in an email to MobiHealthNews. “This may change patient care in terms of decreasing the indirect time spent on documentation while increasing overall care team communication and coordination.”

The company said that once a doctor logs in, Capsule Vitals Plus captures the patient’s blood pressure, oxygen saturation, pulse rate and temperature. It can also calculate an early warning score and transmit the validated data to the EHR. 

Different from the first generation of the product, vital plus now supports automatic intervals for non-invasive blood pressure measurements, continuous Sp02 monitoring and physiological alarms. The first generation of the product is upgradeable to the second. 

The product is intended to be used in non-critical care setting, such as the medical-surgical floor and emergency department, as opposed to the ICU.

“As non-critical care environments are rapidly changing, we developed a mobile connectivity solution to increase surveillance, improve workflow and reduce patient risk,” Dr. James Mault, senior vice president and chief medical officer at Qualcomm Life, said in a statement. “Capsule Vitals Plus was designed by clinicians for clinicians to offer advanced usability, chartability and remote management.”

In 2014 Qualcomm acquired French-based, Capsule Technology, a clinical data management company. This acquisition allowed the company to move into the the space of connecting devices within the hospital to the hospital’s EHR and IT systems. 

"Qualcomm is focused on strengthening its position in specific Internet of Everything verticals, like healthcare," Derek Aberle, president of Qualcomm, said in a statement in 2014 about the acquisition. "The acquisition of Capsule expands the breadth of our healthcare platform, enabling us to provide connectivity solutions for the entire care continuum and create one of the world's largest connected health ecosystems. This will be an important step in advancing the Internet of Medical Things.”

In 2015, the first generation of the platform, called Qualcomm’s SmartLinx Vitals Plus, received FDA clearance. It similarly works as a patient monitoring system the integrates vital signs clinical documentation and connectivity into one device.

Qualcomm has recently announced that it is working with Benchmark, an electronics company, to create low-cost, disposable biometric patches that will monitor patients inside and outside of the hospital. The patch will measure temperature and 3D motion.