FDA clears Mayo Clinic spin-off's decision support software

By Aditi Pai
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Ambient Clinical Analytics AWARERochester, Minnesota-based Mayo Clinic spin-off Ambient Clinical Analytics has received FDA 510(k) clearance for a software-based decision support tool, called AWARE.

AWARE stands for Ambient Warning and Response Evaluation. It’s an interface for EMR data that prioritizes and organizes a patient’s medical information in three ways: by organ, chronologically as a timeline, or as a customized checklist that displays only the next steps relevant to that case.

According to Ambient, 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".

“Being able to combine the massive amounts of EMR data with lab data and monitor data and integrate it all into a concise viewer that sorts and provides the information that’s needed at that time for that patient is novel,” CEO Al Berning told MobiHealthNews told MobiHealthNews when the company raised $1.1 million last year. “Throughout the industry, clinicians have adopted it and published research and done conferences throughout the world and gotten feedback from their peers that there’s nothing out there that does that combination.”

Ambient has developed two other offerings. One, called YES Board, is a patient tracking tool for emergency departments. The system, which has been used at Mayo for about five years, allows all staff members in the emergency department to monitor the location and status of all patients from monitor screens throughout the department. The other, called Synthesis, is a mobile viewer for both AWARE and YES Board, allowing doctors to access the same information from their iPads or iPhones.