AI technology for coronary artery disease

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Heartflow Announces FDA 510(k) Clearance and Launch of Next Generation Heartflow Plaque Analysis Platform
Globenewswire· 2025-09-22 20:05
Core Insights - Heartflow, Inc. has received FDA 510(k) clearance for its Next Gen Heartflow Plaque Analysis algorithm, which is now available for use [1][2] - Cigna will cover Heartflow Plaque Analysis across all its lines of business starting in October 2025, following similar coverage by UnitedHealthcare [1][4] Technology Advancements - The Heartflow Plaque Analysis is the only FDA-cleared AI-powered plaque quantification tool, showing a 95% agreement with the gold standard, IVUS [2] - The new algorithm demonstrates a 21% improvement in plaque detection compared to the first-generation algorithm, enhancing clinician confidence in diagnosing CAD [2][3] - The updated platform features advanced 3D color-coded visualization of plaque type, volume, and distribution, providing clinicians with critical insights for care decisions [1][3][13] Clinical Impact - The enhanced nomogram is based on data from approximately 273,000 patients, which is nine times larger than any current plaque quantification study [3] - Heartflow Plaque Analysis has led to medical management changes in over 50% of patients beyond coronary CTA alone, with an expected event reduction of around 15% [5] Industry Position - Heartflow is recognized as a leader in coronary plaque analysis, with a commitment to transforming the management of coronary artery disease [5][6] - The company has supported nearly 500,000 patients worldwide, leveraging clinical rigor and a vast dataset of coronary CTA images [6]
Heartflow to Participate in the Morgan Stanley 23rd Annual Global Healthcare Conference
Globenewswire· 2025-08-27 20:24
Company Overview - Heartflow, Inc. is a leader in AI technology for coronary artery disease (CAD) [1] - The company is advancing coronary care by transforming CAD into a screenable, diagnosable, and manageable condition [3] - Heartflow One is the only complete, non-invasive, precision coronary care platform providing patient insights throughout the guideline-directed CCTA pathway [3] - The AI-driven platform includes Roadmap™ Analysis, FFRCT Analysis, and Plaque Analysis, supported by the ACC/AHA Chest Pain Guideline and backed by over 600 peer-reviewed publications [3] - Heartflow has assisted clinicians in managing over 400,000 patients worldwide [3] Upcoming Events - Members of Heartflow management will participate in a fireside chat at the Morgan Stanley 23 Annual Global Healthcare Conference on September 10, 2025, at 6:15 a.m. PT / 9:15 a.m. ET [1] - A live and archived version of the fireside chat will be available on the Investor Relations section of the Heartflow website [2]
Heartflow, Inc. Announces Pricing of Upsized Initial Public Offering
Globenewswire· 2025-08-08 00:27
Core Points - Heartflow, Inc. has priced its upsized initial public offering (IPO) of 16,666,667 shares at $19.00 per share, aiming for gross proceeds of approximately $316.7 million before expenses [1] - The company has granted underwriters a 30-day option to purchase an additional 2,500,000 shares at the IPO price [1] - Trading on the Nasdaq Global Select Market is set to begin on August 8, 2025, under the ticker symbol "HTFL," with the offering closing expected on August 11, 2025 [1] Company Overview - Heartflow is focused on transforming coronary artery disease (CAD) into a screenable, diagnosable, and manageable condition through its AI-driven platform, Heartflow One [5] - The platform includes features such as Roadmap™ Analysis, FFRCT Analysis, and Plaque Analysis, and is supported by the ACC/AHA Chest Pain Guideline [5] - Heartflow has assisted clinicians in managing over 400,000 patients globally, backed by more than 600 peer-reviewed publications [5]