Heartflow (HTFL) FDA Approvals $28.85 -0.70 (-2.37%) Closing price 04:00 PM EasternExtended Trading$27.98 -0.87 (-3.01%) As of 05:48 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsHeadlinesInsider TradesOwnershipSEC FilingsShort InterestTrendsBuy This Stock Heartflow's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Heartflow (HTFL). Over the past two years, Heartflow has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as FISH&CHIPS. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. FISH&CHIPS FDA Regulatory Events FISH&CHIPS is a drug developed by Heartflow for the following indication: Heartflow Plaque Analysis with Heartflow Plaque Staging. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Presentation - November 9,2025Presentation Drug: FISH&CHIPSAnnounced Date: November 9, 2025Indication: Heartflow Plaque Analysis with Heartflow Plaque StagingAnnouncementHeartflow, Inc announced late-breaking data from the FISH&CHIPS Study presented at the American Heart Association (AHA) Scientific Sessions 2025.AI SummaryHeartflow, Inc. announced late-breaking data from the FISH&CHIPS Study presented at the AHA Scientific Sessions 2025. A retrospective analysis of nearly 8,000 symptomatic patients validated Heartflow Plaque Staging based on total plaque volume (TPV) — the largest validation to date. Patients in the highest TPV stage had more than a fivefold higher risk of major cardiovascular events than those in the lowest stage (hazard ratio 5.10, p<0.0001). Higher plaque stages were independently linked to increased rates of cardiovascular death and myocardial infarction over a median 3.3 years. These associations held after adjusting for coronary stenosis, FFRCT and standard risk factors. Investigators said TPV-based staging can help predict who is most at risk and support personalized treatment to prevent heart attacks and death. Heartflow says the data add to growing evidence that AI-powered plaque measurement can change clinical decision making and guide more targeted care.Read Announcement Heartflow FDA Events - Frequently Asked Questions Has Heartflow received FDA approval? As of now, Heartflow (HTFL) has not received any FDA approvals for its therapy in the last two years. What drugs has Heartflow submitted to the FDA? In the past two years, Heartflow (HTFL) has reported FDA regulatory activity for FISH&CHIPS. What is the most recent FDA event for Heartflow? The most recent FDA-related event for Heartflow occurred on November 9, 2025, involving FISH&CHIPS. The update was categorized as "Presentation," with the company reporting: "Heartflow, Inc announced late-breaking data from the FISH&CHIPS Study presented at the American Heart Association (AHA) Scientific Sessions 2025." What conditions do Heartflow's current drugs treat? Currently, Heartflow has one therapy (FISH&CHIPS) targeting the following condition: Heartflow Plaque Analysis with Heartflow Plaque Staging. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events argenex FDA EventsAxsome Therapeutics FDA EventsBiogen FDA EventsCabaletta Bio FDA EventsDyne Therapeutics FDA EventsFibroBiologics FDA EventsIDEAYA Biosciences FDA EventsLexicon Pharmaceuticals FDA EventsMannKind FDA EventsInsulet FDA EventsTG Therapeutics FDA EventsTenaya Therapeutics FDA EventsJohnson & Johnson FDA EventsCandel Therapeutics FDA EventsCelcuity FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Celcuity FDA Events Veracyte FDA Events Definium Therapeutics FDA Events Viridian Therapeutics FDA Events CareDx FDA Events Personalis FDA Events Castle Biosciences FDA Events Fulgent Genetics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:HTFL last updated on 11/10/2025 by MarketBeat.com Staff. 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Presentation - November 9,2025Presentation Drug: FISH&CHIPSAnnounced Date: November 9, 2025Indication: Heartflow Plaque Analysis with Heartflow Plaque StagingAnnouncementHeartflow, Inc announced late-breaking data from the FISH&CHIPS Study presented at the American Heart Association (AHA) Scientific Sessions 2025.AI SummaryHeartflow, Inc. announced late-breaking data from the FISH&CHIPS Study presented at the AHA Scientific Sessions 2025. A retrospective analysis of nearly 8,000 symptomatic patients validated Heartflow Plaque Staging based on total plaque volume (TPV) — the largest validation to date. Patients in the highest TPV stage had more than a fivefold higher risk of major cardiovascular events than those in the lowest stage (hazard ratio 5.10, p<0.0001). Higher plaque stages were independently linked to increased rates of cardiovascular death and myocardial infarction over a median 3.3 years. These associations held after adjusting for coronary stenosis, FFRCT and standard risk factors. Investigators said TPV-based staging can help predict who is most at risk and support personalized treatment to prevent heart attacks and death. Heartflow says the data add to growing evidence that AI-powered plaque measurement can change clinical decision making and guide more targeted care.Read Announcement
