Camden, NJ (PRWEB) October 22, 2013 -- mVisum, Inc., an innovative provider of alarm management technology solutions for health systems, announced today that its Alert Alarm Management platform meets the U.S. Food and Drug Administration's (FDA) recently-announced final regulatory guidance for mobile medical applications. The mVisum platform is the first and only FDA 510(k)-cleared alarm management solution compatible with major smart devices and mobile operating systems. The full guidance document is available on the FDA website.
The FDA’s guidance for mobile medical applications, which it announced in late September, reiterates the FDA’s stance that any hardware or software that serves as an accessory to regulated medical devices must also be regulated. Systems with even a single unregulated component, such as an alarm handling software application or endpoint device, now create regulatory risk for health systems that use them.
“With its publication of this final guidance, the FDA is establishing important guidelines that impact the handling of critical alert data through the entire lifecycle of the alarm signal,” said Praveen Dala, CEO of mVisum. “As a result, hospitals and health systems can confidently implement technology solutions that meet the highest standards for quality, safety, performance and compatibility.”
The mVisum Alarm Management solution delivers audio-visual alarm notifications, waveforms, vital signs and other key alarm data to nurses on the care floor in real time via connected smart devices. With the ability to instantly differentiate alarms by source and criticality and view waveforms and other clinical evidence, clinicians have the information they need to provide a rapid, medically-accurate and patient-specific response to every critical alert.
As an FDA 501(k)-cleared true closed-loop technology platform, the mVisum Alarm Management solution enables hospitals and health systems to implement a traceable, floor-specific workflow that greatly reduces alarm noise while improving response time and accuracy. In addition, all data is constantly analyzed to enable nurse managers to configure and fine-tune alert triggers from monitoring devices to minimize overload from false positives.
“Alarm fatigue is a significant and under-publicized threat to patient safety,” said Dala. “We are proud to bring health systems a game-changing platform for resolving alarm fatigue that meets both 510(k) and mobile-app-specific FDA guidelines for medical devices, which makes it unique among currently-available alarm management technologies.”
Please click a link below to view related materials:
- mVisum’s FDA 510(k) Clearance Notice
- FDA Mobile Medical Application Guidance (PDF)
About mVisum
mVisum is a leading provider of Enterprise-wide technology solutions that drive quality, safety, productivity and value for hospitals. mVisum’s alarm management platform helps hospitals resolve alarm fatigue, improve care quality, support unified care workflows, and enhance patient safety and satisfaction. For more information, visit http://www.mvisum.com/.
Dave Clossey, mVisum, http://www.mvisum.com, +1 301-294-9900, [email protected]
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