Baltimore-based Sonavi Labs recently ticked off a key milestone for a medtech company on the path to commercialization: approval from the U.S. Food and Drug Administration.

The medical device clearance, known as 510(k) in regulatory parlance, is for the hardware portion of the company’s systems. Called Feelix, it enables the stethoscope that’s a familiar feature of any doctor’s visit to be used beyond the clinic. Designed to detect respiratory ailments, the device contains a microphone array and noise suppression technology.

“It removes ambient noises from any environment,” said Chief Business Development Officer Brandon Dottin-Haley.

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