HTFL Gains FDA Clearance & Cigna Coverage for Next Gen Plaque Analysis

Heartflow HTFL has secured a dual milestone with FDA 510(k) clearance for its Next Gen Plaque Analysis platform and new nationwide coverage from Cigna, effective October. The update enhances detection accuracy by 21% compared to the prior version and offers 3D visualization of plaque type, volume and distribution, enabling clinicians to make more precise and confident care decisions.The update underscores Heartflow’s strategy to pair clinical innovation with broader accessibility, following UnitedHealthcare’s earlier coverage decision. Leveraging data from nearly 273,000 patients, the largest coronary CTA dataset, Heartflow’s advanced algorithm provides an unmatched view into coronary plaque burden. Together with Cigna’s coverage, the platform’s clinical rigor positions Heartflow to accelerate its role in reshaping cardiovascular care nationwide.Likely Trend of HTFL Stock Following the NewsFollowing the announcement, the company's shares have traded flat and closed at $33.06 on Friday. Shares have gained 15% in the last three months compared with the industry’s 3.9% growth. The S&P 500 has gained 8.4% in the same time frame.In the long run, FDA clearance paired with expanded Cigna coverage positions HTFL to drive broader adoption of its Plaque Analysis platform, creating recurring revenue opportunities while strengthening clinical trust. With two major national insurers now on board and a differentiated AI solution backed by the largest coronary CTA dataset, Heartflow is well-placed to scale its technology, deepen integration into standard CAD care pathways and build a durable competitive moat that supports sustained growth and market leadership.Meanwhile, HTFL currently has a market capitalization of $2.76 billion.Image Source: Zacks Investment ResearchMore on the NewsThe Next Gen Heartflow Plaque Analysis platform represents the most advanced iteration of the company’s AI-driven coronary care technology. It is the only FDA-cleared, AI-powered plaque quantification tool, demonstrating a 95% agreement with the gold standard IVUS through blinded core lab adjudication. The updated algorithm improves plaque detection by 21% compared to the first-generation version, while enhanced 3D color-coded visualization enables clinicians to differentiate between plaque types, volumes, and distributions with unprecedented clarity.Backed by a nomogram powered by data from approximately 273,000 patients, which is nine times larger than any other plaque quantification study, this upgrade provides physicians with highly representative insights, allowing for faster and more accurate risk prediction and patient-specific treatment strategies. The platform builds on evidence from the landmark DECIDE Registry, which demonstrated that Heartflow Plaque Analysis altered medical management in more than 50% of patients beyond CTA alone and is expected to result in a 15% reduction in adverse events.The addition of Cigna as the second major national insurer to provide coverage for Heartflow Plaque Analysis, effective Oct. 1, 2025, significantly enhances the platform’s accessibility and adoption. Coverage applies to patients with acute or stable chest pain and mild-to-moderate coronary narrowing (1–69% stenosis) identified on CTA, fully aligning with EviCore guidelines.Following UnitedHealthcare’s earlier move, Cigna’s decision further validates the clinical value of Heartflow’s technology and ensures reimbursement across a broader U.S. patient base. This coverage not only reduces financial barriers for patients and providers but also strengthens Heartflow’s positioning as a standard-of-care tool in CAD diagnosis and management. With its unique ability to quantify and contextualize coronary plaque alongside FFRCT insights, Heartflow is poised to expand utilization, improve patient outcomes, and accelerate its growth trajectory within precision cardiovascular care.HTFL’s Zacks Rank & Stocks to ConsiderHTFL carries a Zacks Rank #3 (Hold) at present.Some better-ranked stocks in the broader medical space are West Pharmaceutical Services, Inc. WST, Medpace Holdings, Inc. MEDP and Envista NVST.West Pharmaceutical reported second-quarter 2025 adjusted earnings per share (EPS) of $1.84, which beat the Zacks Consensus Estimate by 21.9%. Revenues of $766.5 million surpassed the consensus estimate by 5.4%. It currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.West Pharmaceutical has a long-term estimated growth rate of 8.5%. WST’s earnings surpassed estimates in each of the trailing four quarters, with an average surprise of 16.8%.Medpace Holdings, sporting a Zacks Rank of 1, reported second-quarter 2025 EPS of $3.10, which beat the Zacks Consensus Estimate by 3.3%. Revenues of $603.3 million outpaced the consensus mark by 11.5%.Medpace Holdings has a long-term estimated growth rate of 11.4%. MEDP’s earnings surpassed estimates in each of the trailing four quarters, with an average surprise of 13.9%.Envista reported second-quarter 2025 adjusted EPS of 26 cents, which beat the Zacks Consensus Estimate by 8.3%. Revenues of $682 million surpassed the Zacks Consensus Estimate by 6.3%. It currently carries a Zacks Rank #2 (Buy).Envista has a long-term estimated growth rate of 16.8%. 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Click to get this free report West Pharmaceutical Services, Inc. (WST): Free Stock Analysis Report Medpace Holdings, Inc. (MEDP): Free Stock Analysis Report Envista Holdings Corporation (NVST): Free Stock Analysis Report Heartflow, Inc. (HTFL): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks