Sparrow BioAcoustics, legally incorporated as Sparrow Acoustics Inc., is a Canadian medical software company that develops software for the recording and analysis of heart and lung sounds. Founded in 2019 and based in St. John's, Newfoundland and Labrador, the company's principal product is Stethophone, a software as a medical device (SaMD) application that uses a smartphone's built‑in microphone to perform cardiac and pulmonary auscultation without additional hardware. Stethophone received U.S. Food and Drug Administration (FDA) 510(k) clearance as a Class II device in 2023 and was licensed by Health Canada in 2024.
History Sparrow Acoustics Inc. was incorporated in Canada in 2019. It was co‑founded by Nadia Ivanova, the company's chief product officer, and Yaroslav Shpak, a cardiologist who serves as chief medical officer. Mark Attila Opauszky, previously chief executive of the software company PathFactory, joined as chief executive officer. The first version of the software, then named "Stethophone v1," was cleared by the FDA as a Class II medical device on March 29, 2023, permitting health care professionals to capture heart and lung sounds through a smartphone microphone. In October 2023, Stethophone received FDA clearance for its intended use by both healthcare professionals and lay users in clinical and non‑clinical environments. In June 2023, Stethophone received the initial certification from the Ukrainian Center for Medical Certification and Prognostication. In February 2024, Sparrow Acoustics Inc. launched Stethophone in the United States. In June 2024, the company launched Stethophone in Ukraine, allowing users to record, analyze, store, and share heart sound recordings. On September 19, 2024, the software received FDA clearance under the device name "Stethophone Pro" intended for use by healthcare professionals or on the order of healthcare professionals, and includes prescription‑only automated analysis of heart sounds and phonocardiograms. On September 20, 2024, Stethophone received a Health Canada license as a Class 2 medical device. In November 2024, Sparrow Acoustics Inc. launched Stethophone in Canada. In September 2025, Stethophone Pro was cleared by the FDA – the fourth FDA clearance in the product line.
Financing In September 2021, Sparrow Acoustics Inc. raised $3.25 million CAD in a pre‑Series A round from Killick Capital Inc. and Klister Credit Corp. The same month, Mark Attila Opauszky, previously chief executive of Toronto‑based marketing technology company PathFactory for nine years, joined as chief executive officer, with co‑founder Nadia Ivanova moving into the role of chief product officer. In October 2024, following its FDA and Ukrainian regulatory clearances, the company closed a further $10 million in seed financing, again led by Killick Capital and Klister Credit, with participation from Newfoundland and Labrador‑based venture firm Pelorus Ventures. A company statement described the combined round as $13 million; BetaKit reported that Opauszky attributed the figure to the 2021 raise (approximately $3 million) plus the new $10 million. The same year, in November 2024, the Government of Newfoundland and Labrador announced C$380,000 in research‑and‑development funding to help Sparrow BioAcoustics complete a proof of concept for an AI‑enhanced version of Stethophone intended to seek FDA clearance, alongside a C$500,000 contribution from the Atlantic Canada Opportunities Agency and C$349,000 from the company itself, for total project funding of C$1,229,000. In October 2025, the company closed an additional all‑equity round of $10 million CAD, again led by Killick Capital and Klister Credit, with participation from Pelorus VC, Brinex Capital, and the family office of former Verafin vice‑president Kevin Baker. BetaKit reported that the round brought the company's total funding to date to approximately $23 million.
Products and technology Stethophone is a software application for iOS smartphones that records chest sounds through the smartphone's microphone and applies signal‑processing algorithms intended to make heart and lung sounds audible without an external sensor or attachment. Recordings can be stored, replayed and shared, and are presented visually as an oscillogram and a spectrogram. The application offers a set of selectable audio filters, including:
Bell – traditional filter used in stethoscopes for low‑frequency sounds, Diaphragm – traditional filter used for higher‑frequency sounds of heart and lungs, and Starling – filter for listening to the full frequency of chest sounds. The software performs an automated analysis of recorded heart sounds. According to the FDA clearance summary, the software analyzes heart sounds and phonocardiograms and can automatically detect murmurs that may be present, sound timing and character, including S1, S2, and the absence of a heart murmur. Unlike Stethophone in Canada and Ukraine, the analysis feature in Stethophone Pro is restricted to use by or on the order of a licensed health care practitioner and is intended to support, not replace, clinical judgement.
Regulatory status United States – FDA 510(k) clearances have been issued for Stethophone (K222871, 2023; K231551, 2023) and for Stethophone Pro with heart‑sound analysis (K240901, 2024; K252595, 2025). The device is classified as Class II. Canada – Stethophone is a licensed Class II medical device in Health Canada's Medical Devices Active Licence Listing. Ukraine – Stethophone received the initial certification from the Ukrainian Center for Medical Certification and Prognostication.
Clinical research In March 2026, Sunnybrook Health Sciences Centre and KMH Cardiology Centres announced the SAGE Trial, described as the first randomised trial in Canada to evaluate a smartphone application for the early detection of aortic stenosis in primary care. Patients seen in community primary care offices are eligible. The trial's co‑principal investigators are Nick Bowers, an interventional and structural cardiologist in Sunnybrook's Schulich Heart Program, and Derrick Tam, a cardiac surgeon at the same hospital.
Recognition In November 2023, Stethophone received the Best Tech Award at the Tech Forward Awards, presented annually by the Atlantic Canadian technology association Digital Nova Scotia. Sparrow BioAcoustics was named among the winners of the 2025 CIO Awards Canada, presented by the research firm International Data Corporation.
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