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.
The FDA has three classes with highest level being Class 3, which is typically used for implantable devices like pacemakers and heart valves. Dental floss is categorized as a Class 1 device. An example of a device with a Class 2 ranking is a condom.
Ambient, which licenses the core of the AWARE software from Mayo Clinic, describes it as "a clinical decision support tool."
Berning explained that means it uses algorithms to shift through massive amounts patient data, prescription reports and more to select the most important information for the clinical staff to consider during real-time treatment of patients.
"It takes a lot of administrative and IT drudgery off of the physician to allow them to focus on medical care," he said.
Ambient has 10 employees and it's based in the Mayo Clinic Biobusiness Accelerator in the Minnesota Biobusiness Center. Berning says the firm plans to add more employees within the next several months.
"We could need to double or triple our staff," he said.
Berning plans to announce the commercial availability of AWARE at the top health care software industry conference next week in Chicago.
"That's where we'll let everyone know that we are open for business," he said.