Heard on the Street: FDA gives green light to local software firm
Posted by Ambient Clinical Analytics on May 13th, 2015
Jeff Kiger at postbulletin.com writes a feature on Ambient Clinical Anylitics recent FDA Approval.
A Rochester medical software start-up with financial ties to Mayo Clinic says getting approval from the U.S. Food and Drug Administration is a major milestone for the company.
“It’s tough to get. It’s a big deal for us. Historically been rare in the software industry to have these type of devices to fall into that class,” said Al Berning, CEO of Ambient Clinical Analytics.
Berning is known in Rochester as a former IBMer, a co-founder of Pemstar and former CEO of Hardcore Computers/LiquidCool Solutions.
Ambient, which was founded in 2013, makes analytical software that helps physicians make decisions about patient treatment in emergency room and intensive care situations. The FDA gave 510(k) clearance for Ambient’s AWARE software platform as a Class 2 device this week.
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Category: Ambient in the News