St. John’s-based Sparrow BioAcoustics is celebrating Health Canada’s approval of Stethophone, an AI-powered app that allows users to capture and analyze heart sounds using a smartphone.

Designed for both healthcare professionals and personal use, Stethophone helps detect structural and rhythmic heart anomalies. The company is aiming to build the world’s biggest databank of cardiological recordings.

"This authorization from Health Canada allows us to offer Stethophone to every Canadian with a heart concern, whether for themselves or someone in their care," said Mark Opauszky, CEO of Sparrow BioAcoustics in a press release.

Testing and validation of the device involved thousands of patients, supported by doctors from Canada and the international cardiology community.

Just last month, Sparrow closed a $10M funding round. Stethophone won Food and Drug Administration approval in the U.S. in 2023 allowing it to be used by medical professionals in the United States. At the time, the company said it was the first-ever FDA-cleared smartphone stethoscope Software-as-a-Medical-Device.

Stethophone is expected to launch within days.