Cleerly
Cleerly makes FDA-cleared AI software that reads heart CT scans to measure plaque and blocked arteries.
On the record
Checkpoint: Markman hearing and preliminary injunction motions in HeartFlow v. Cleerly, E.D. Texas
The call
Cleerly has the regulatory approvals, billing code, and hospital deals to grow, but a patent and trade secret lawsuit from HeartFlow now sits over its core product.
Cleerly builds computer software that reads heart scan images to help doctors decide if patients need surgery. The company has real advantages: the FDA has approved it, insurance companies cover it for millions of patients, and hospitals are buying it. However, HeartFlow, a bigger company that makes similar software, sued Cleerly in April 2026, claiming Cleerly stole its ideas and technology. HeartFlow says Cleerly's top leader used to work for HeartFlow and saw how their software worked. The lawsuit outcome in the next few years will decide whether Cleerly survives and grows or gets blocked from selling its main product.
Why
01
AI pressure: None apparent. The threat here isn't a generic AI model eating the business, it's a rival AI diagnostics company with more patents and a head start. Could AI do the core job? Unlikely.
02
Bigger players: HeartFlow, Inc.. HeartFlow sued Cleerly in April 2026 claiming its plaque analysis tech and trade secrets came from the CEO's prior consulting work at HeartFlow. Could a giant copy it? Probably.
03
What protects it. FDA clearances, a dedicated CPT billing code, coverage for 86 million lives, and 15 years of proprietary scan data from over 40,000 patients.
What would change this call
Ruling or settlement in HeartFlow v. Cleerly (E.D. Texas, Case 2:2026cv00292). Determines whether Cleerly can keep selling its core product without restriction.
Preliminary-injunction motion or Markman hearing scheduling in the case. Signals rising odds of a court-ordered restriction on Cleerly's product.
Continued monthly payer-coverage additions (e.g., beyond Aetna, Cigna, Humana) through 2026. Shows Cleerly's commercial adoption is still expanding despite litigation risk.
Preliminary-injunction motion or Markman hearing scheduling in the case. Signals rising odds of a court-ordered restriction on Cleerly's product.
Continued monthly payer-coverage additions (e.g., beyond Aetna, Cigna, Humana) through 2026. Shows Cleerly's commercial adoption is still expanding despite litigation risk.
Key numbers
- 86M+ covered lives across major payers
- $106M raise led by Insight Partners, ~$386.5M total
- Headcount grew from 163 to 354 in two years
Named risks
- HeartFlow patent and trade-secret lawsuit could restrict core product sales if Cleerly loses.
- Trade-secret claims tied directly to CEO's prior HeartFlow consulting relationship, 2012 to 2017.
- Shared CPT code with HeartFlow and Elucid since January 2026 erodes reimbursement differentiation.
- Conflicting, unverified third-party revenue estimates undermine financial transparency.
- Cheaper non-contrast competitor HeartLung.AI attacking value proposition of CCTA-based analysis.
Rivals, as read in July 2026
| Rival | Direction | Evidence |
|---|---|---|
| HeartFlow | losing to | HeartFlow sued Cleerly for patent and trade-secret infringement, filed April 13, 2026, E.D. Texas |
| HeartFlow | contesting | HeartFlow holds 600+ patents and FDA clearance since 2014 versus Cleerly's newer clearances |
| Elucid | contesting | Named alongside Cleerly and HeartFlow under shared CPT code effective January 2026 |
| HeartLung.AI | gaining on | Runs 'Why Pay More and Get Less?' campaign against Cleerly's contrast-based CCTA pricing |
Questions people ask
- Is Cleerly profitable?
- No public revenue or profitability figures exist. Third-party estimates conflict sharply, from ~$35.8M/year (Growjo, 2022) to $4.3M (Datanyze, undated), and neither is verified. Cleerly is venture-backed and privately held, having raised roughly $386.5M through a Dec 4, 2024 Series C extension.
- Who owns Cleerly?
- Cleerly, Inc. is privately held and venture-backed, not publicly traded. Major investors include Insight Partners, Battery Ventures, T. Rowe Price, Fidelity, Vensana Capital, and Cigna Ventures, with the latest $106M raise closing December 4, 2024 led by Insight Partners.
- Is Cleerly being sued by HeartFlow?
- Yes. HeartFlow, Inc. filed suit against Cleerly, Inc. on April 13, 2026 in the Eastern District of Texas (Case 2:2026cv00292), alleging infringement of six patents plus trade-secret misappropriation tied to CEO Dr. James K. Min's 2012-2017 HeartFlow consulting history. Cleerly's answer was due July 8, 2026.
- Could AI replace Cleerly?
- Cleerly's product is itself an AI diagnostic, so generic AI displacement isn't the risk; competitive AI from rivals is. Its moat rests on FDA clearances, a dedicated CPT code (75580), and a 15-plus year, 40,000-patient imaging dataset cited as of January 6, 2026, which slows but doesn't block well-funded peers like HeartFlow.
- Is Cleerly's biggest competitor HeartFlow?
- Yes. HeartFlow has FDA de novo clearance since 2014, over 600 patents, and is described as the most-utilized AI-CCTA technology in the US. HeartFlow sued Cleerly for patent and trade-secret infringement on April 13, 2026, directly contesting Cleerly's core technology claims.
- Does Cleerly have FDA clearance?
- Yes. Cleerly Labs is FDA-cleared for CCTA plaque and stenosis analysis, Cleerly ISCHEMIA received FDA 510(k) clearance and launched January 9, 2024, and its CAD Staging System received FDA Breakthrough Device Designation and TAP Pilot entry on March 5, 2024.
Timeline
- 2026-05-20MemorialCare adopts Cleerly system-wide, first LA County hospital system to do so
- 2026-04-17Cleerly publicly calls HeartFlow suit an attempt to limit competition, vows to defend
- 2026-04-13HeartFlow sues Cleerly for patent infringement and trade-secret misappropriation in E.D. Texas
- 2026-01-06Aetna approves Cleerly coverage; company claims 86 million-plus covered lives
- 2026-01New shared Category I CPT code for AI coronary plaque analysis takes effect
- 2024-12-04Cleerly raises $106M Series C extension led by Insight Partners
- 2024-03-05Cleerly CAD Staging System receives FDA Breakthrough Device Designation
- 2024-01-09Cleerly ISCHEMIA launches with FDA 510(k) clearance and CPT code 75580
- 2022-07-25Cleerly closes Series C funding round, later extended to $223M
- 2021-06Cleerly raises $43M Series B led by Vensana Capital
Revision history
22 July 2026
First assessed. Losing its protection. The text above is fixed as of this date and is not edited afterwards.
In the same band
Sources
- Cleerly Raises $106 Million in Funding Led by Insight Partners (2024-12-04)
- Cleerly 2026 Company Profile
- Cleerly Raises $106 Million in Funding Led by Insight Partners (2024-12-04)
- Recognition, Growth, Continuous Innovation at Cleerly (2023-12-21)
- Aetna Approves Coverage for Cleerly's AI Cardiovascular Imaging Analysis (2026-01-06)
- MemorialCare Heart & Vascular Institute Becomes First Hospital in LA County to Offer Cleerly (2026-05-20)
- Cleerly Launches Cleerly ISCHEMIA Solution for Heart Disease Analysis (2024-01-09)
- Cleerly Receives FDA Breakthrough Device Designation for Heart Disease Risk Staging System (2024-03-05)
- New Category I CPT code issued for AI-enabled coronary plaque analysis software (2024-10-18)
- Cleerly - Headcount, Funding & Open Jobs (2026-06-20)
- Heartflow sues Cleerly over alleged patent infringement (2026-04-15)
- AI Medical Technology Meets IP Law in Patent Infringement Suit