FDA clears Heartflow’s AI plaque analysis tool, Cigna to cover it

MOUNTAIN VIEW, Calif. - Heartflow, Inc. (NASDAQ:HTFL), a medical technology company with a market capitalization of $2.75 billion, announced Monday that the FDA has granted 510(k) clearance for its Next Gen Heartflow Plaque Analysis algorithm, which is now available for clinical use. The company, which maintains strong liquidity with a current ratio of 3.6, also secured coverage from Cigna for the technology across all its health plans beginning in October. According to InvestingPro analysis, the stock currently appears overvalued relative to its Fair Value.

The AI-powered plaque quantification tool features an updated algorithm with a reported 21% improvement in plaque detection compared to its first-generation version. According to the company, which boasts an impressive gross profit margin of 75.34%, the technology has demonstrated 95% agreement with intravascular ultrasound (IVUS), which is considered the gold standard for plaque assessment.

Cigna becomes the second national insurer to cover Heartflow Plaque Analysis, following UnitedHealthcare. The coverage will apply to Cigna patients with acute or stable chest pain who have mild-to-moderate narrowing of coronary arteries identified on coronary CT angiography.

"Cigna’s decision to cover Heartflow Plaque Analysis is a testament to the power of our technology," said John Farquhar, President and CEO of Heartflow, in the press release.

The updated platform provides 3D color-coded visualization of plaque type, volume, and distribution. The company states its enhanced nomogram is powered by data from approximately 273,000 patients.

Matthew Budoff, Professor of Medicine at UCLA Medical Center, noted in the statement that understanding plaque type and distribution "is critical in predicting patient risk and guiding personalized treatment."

The company recently presented data from its DECIDE Registry showing that Heartflow Plaque Analysis led to medical management changes in over 50% of patients beyond coronary CT angiography alone.

Heartflow’s technology is designed to help clinicians assess coronary artery disease without invasive procedures by creating 3D models from CT images.

In other recent news, Heartflow Inc reported its Q2 2025 financial results, revealing revenue of $43.4 million, slightly surpassing Canaccord Genuity’s estimate of $43.2 million. Following this announcement, Canaccord Genuity raised its price target for Heartflow to $39, maintaining a Buy rating. Morgan Stanley initiated coverage on Heartflow with an Equalweight rating and a price target of $35, commenting on the stock’s valuation compared to its peers. Canaccord Genuity also initiated coverage, expressing optimism about Heartflow’s AI cardiac tools and setting a price target of $35 with a Buy rating.

Piper Sandler joined the coverage with an Overweight rating and a $38 price target, highlighting Heartflow’s AI potential in coronary artery disease diagnostics. JPMorgan also initiated an Overweight rating with a $36 price target, emphasizing Heartflow’s role in the AI healthcare sector. These developments reflect the growing interest and varied perspectives among analysts regarding Heartflow’s market position and future potential.

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