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Ambient Clinical Analytics Receives FDA 510(k) Clearance for Clinical Decision Support Tool AWARE

Ambient Clinical Analytics Receives FDA 510(k) Clearance for Clinical Decision Support Tool AWARE

FDA approval of Ambient Clinical Analytics key clinical EMR tools means the company’s medical IT products are commercially available today.

Rochester, MN — Ambient Clinical Analytics announced today it received 510(k) U.S. Food and Drug Administration (FDA) clearance for AWARE.  AWARE is a clinical decision support tool, combined with a scientifically supported EMR viewer.  The product reduces clinician information overload by using analytics to filter relevant patient data and provide timely, actionable information.  The goal of the product is to clearly and concisely present actionable information to all care team members to improve patient outcomes, reduce the cost of care, and support best-care practices for ICUs and other critical care areas. 

The FDA 510(k) clearance is for Class 2 medical devices that provide analytics-based clinical decision support beyond that provided by Class 1 viewers and dashboards. 

“FDA clearance is an important step for Ambient Clinical Analytics in providing a comprehensive clinical decision support system that is available for installation today. We are excited to be launching AWARE at HIMSS15,” said Al Berning, CEO.   

AWARE is a pivotal technology in Ambient’s portfolio of technologies, licensed from Mayo Clinic, that are changing the way critical care providers operate. 

Ambient Clinical Analytics provides clinical decision support tools for the ICU, Emergency Departments and other critical care areas right at the patient’s bedside.

In addition to AWARE, Ambient Clinical Analytics’ technologies include:

• Mayo Clinic YES Board®, a multi-patient management tool that provides real-time situational awareness for Emergency Departments and hospital Pediatric departments;

• Syndromic Surveillance, which delivers Smart alerts or “sniffers” that address important clinical problems such as sepsis; and

• Synthesis, a component for both the YES Board and AWARE, which connects patients’ data with mobile devices.

Ambient Clinical Analytics is announcing the commercial availability of AWARE at HIMSS15, the healthcare IT event of the year being held April 12 – 15 in Chicago.

One of the event’s cutting-edge health IT products, AWARE will be on display with Mayo Clinic YES Board®, and Syndromic Surveillance in Booth # 5443. 

Ambient Clinical Analytics was launched last year at HIMSS by a world-class founding clinical team from Mayo Clinic, including physicians from multiple specialties, who joined CEO Al Berning, a technology veteran of 20 years. 

About Ambient Clinical Analytics

Ambient Clinical Analytics sells powerful bedside real-time healthcare data assimilation, communication, and analytics based clinical decision support tools that support the ICU, Emergency Department and other critical care areas. Our business model is supported by software license fees, SaaS, Cloud and system integration revenue.  Ambient Clinical Analytics have an MD and executive team with strong track records in medicine, clinical research and informatics, medical products and IT.

Additional information about Ambient Clinical Analytics can be found by visiting:

Media Contact
Company Name: Ambient Clinical Analytics
Contact Person: Patti Hill
Email: Send Email
Phone: 512-218-0401
City: Rochester
State: MN
Country: United States


February 2018
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