Heartflow sues cardiology AI rival Cleerly over alleged patent infringement
Heartflow, the California-based artificial intelligence (AI) company known for its coronary CT angiography (CCTA) automated analysis algorithms, has filed a patent infringement lawsuit against one of its biggest rivals.
According to the lawsuit, filed in the U.S. District Court for the Eastern District of Texas, Denver-based Cleerly is infringing on six different Heartflow patents with its own AI-powered CCTA software offerings. The lawsuit describes Cleerly’s actions as “one of the most egregious examples of piracy in the medical technology industry” and highlights the time James K. Min, MD, Cleerly’s founder and CEO, spent as a Heartflow consultant.
Cleerly also brought in Brent Ness, a Heartflow executive from 2014 to 2015, to serve as the company’s president and chief commercial officer from 2019 to 2021. According to the lawsuit, Ness had access to “intimate knowledge of Heartflow’s technology, its patents, its commercial strategies, and its competitive advantages” from those early years he spent with Heartflow. Heartflow alleges that Cleerly used this information to “develop and market its infringing products.”
“Heartflow pioneered a significant medical technology that has touched over 600,000 patients' lives,” John Farquhar, Heartflow’s CEO, said in a prepared statement. “Our team has worked tirelessly since 2010 to develop the Heartflow platform, a first-of-its-kind AI solution that has been used to detect and manage coronary artery disease. We take seriously our responsibility to protect the intellectual property that supports this field and the clinicians and patients it serves.”
Heartflow is seeking damages, including years of lost profits, and demanding a jury trial. Click here to read the company’s lawsuit in full.
Heartflow's Plaque Analysis software on display at TCT 2024.
Cleerly remains confident in the value, integrity of its AI algorithms
Cleerly has acknowledged Heartflow’s lawsuit and responded with a statement of its own.
“We are confident in our extensive and well-established intellectual property portfolio and the originality of our technology,” Min said in the company’s statement. “Cleerly has published landmark clinical science that has redefined how cardiovascular disease is understood and treated, which has formed the basis of our novel technologies that provide physicians with actionable insights into their patients’ heart health. Cleerly was founded on a mission to create a world without heart attacks, and we have never been more focused in our mission and committed to the patients and physicians who count on us.”
One of healthcare’s biggest trends
The AI-powered heart assessments sold by Heartflow and Cleerly represent one of the biggest trends in both cardiology and radiology. These automated tests are noninvasive and help cardiologists provide preventive care and develop personalized treatment strategies for their patients.
The U.S. Food and Drug Administration (FDA) has approved AI-enabled CCTA analysis tools from Heartflow, Cleerly, Elucid, Circle Cardiovascular Imaging, Caristo Diagnostics, Artrya and Keya Medical. These technologies have also received improved Medicare coverage and new Category 1 CPT codes. In addition, an updated payment policy first announced in 2024 more than doubled the reimbursements hospitals receive for performing CCTA; this improved access to these tools for healthcare providers all over the country.
Click here and here for recent Cardiovascular Business video interviews on the value of AI-powered CCTA evaluations.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.