KardioDiagnostix Eyes Clinical Study

by | Sep 27, 2024 | Success Story

From: Entrevestor
Date: Sept. 25, 2024

The developer of cardiology AI is collaborating with N.L.’s Sparrow Bioacoustics.

KardioDiagnostix, the Halifax maker of AI for analyzing paediatric heart murmurs, has expanded its research and development efforts via an agreement with a clinic in Toronto after gathering data from about 400 patients in Nova Scotia.

In an interview this week, Co-Founders Dr. Robert Chen, Dr. Santokh Dhillon and Mohammed Shameer Iqbal, the CEO, said they hope to commence similar operations in the United States, Saudi Arabia and India by the end of this year.

The final regulatory hurdle KardioDiagnostix must clear to receive Health Canada approval is conducting a clinical study to prove the software is effective. With the right staffing, which the founders plan to fund with an in-progress, $2 million raise, Iqbal said the study will likely take about five months.

“The sensitivity of our tool now is as good, maybe even better than a cardiologist,” said Chen. “Specificity is the same as a cardiologist. So basically, the tool gives access to a paediatric cardiologist to every primary care person.”

Iqbal said Canadian regulators are willing to accept some types of data from research conducted in the U.S., while American regulators have requirements that are in some ways stricter, such as in their requirements about the demographic makeup of studies. That, plus, the fact the data is being gathered in Canada, makes it possible that approval could come before the U.S. sign-off, but he hopes to commercialize in both countries at relatively the same time.

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