Articles from Cleerly

Cleerly, the leader in cardiovascular AI imaging, has announced revolutionary findings from its late-breaking clinical trial presented at the American College of Cardiology's Annual Scientific Session + Expo (ACC.25) in Chicago, Illinois. The study, titled “Artificial Intelligence-based Quantitative Computed Tomography (AI-QCT) Coronary Plaque Features Predict Risk More Pronounced in Females: The International Multicentric Registry CONFIRM2,” was led by Gudrun M. Feuchtner, MD, MBA, and presented during the Clinical and Investigative Horizons I session on March 31st, 2025. This research is simultaneously published today in Circulation: Cardiovascular Imaging, a peer-reviewed journal of the American Heart Association.

Cleerly, the leader in cardiovascular AI imaging, announces its participation in the American College of Cardiology Annual Scientific Session + Expo (ACC.25) from March 29-31, 2025, at the McCormick Place Convention Center in Chicago, Illinois. Cleerly will share its late-breaking findings on Artificial Intelligence-based Quantitative Computed Tomography’s (AI-QCT’s) role in identifying risks of future major adverse cardiovascular events (MACE) in women. Onsite, Cleerly will demonstrate the company’s AI-enabled coronary computed tomography angiography (CCTA) solution to help guide personalized prognosis, diagnosis, and treatment of coronary artery disease (CAD).

Cleerly, a leader in AI imaging technology, is proud to support the American College of Cardiology’s (ACC) Chicago Community Health Fair. This event will take place on Tuesday, March 25, from 3-7 p.m. CT at The Salvation Army Ray & Joan Kroc Corps Community Center.

Bunkerhill Health, a leader in AI-enabled early disease detection, and Cleerly, a pioneer in advanced cardiovascular imaging, announced today a strategic partnership to expand access to their technologies for coronary artery disease detection and risk assessment. The collaboration leverages both companies’ FDA-cleared solutions to help health systems identify at-risk patients earlier and deliver comprehensive cardiovascular care.

Cleerly, a leader in advanced cardiovascular imaging, announced it will be presenting at the American Heart Association (AHA) Scientific Sessions November 16 to 18 in Chicago, IL, at the McCormick Place Convention Center. Cleerly will share findings from AI-Quantitative Coronary CT (AI-QCT) imaging on coronary artery plaque characteristics, sex and age-related differences, and the implications of revascularization and atherosclerosis progression. Onsite, Cleerly will demonstrate the company’s AI-enabled coronary computed tomography angiography (CCTA) solution to help guide personalized prognosis, diagnosis, and treatment of coronary artery disease (CAD).

Late-breaking study results were presented today at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 conference as part of the CONFIRM2 global multicenter study, which demonstrated how a non-invasive, comprehensive AI-based analysis of cardiac computed tomography (CT) can predict serious heart-related events in patients who show symptoms of coronary artery disease (CAD).

Cleerly, a pioneer in advanced cardiovascular imaging, is thrilled to announce that the American Medical Association (AMA) has approved a CPT Category I code for its AI-QCT advanced plaque analyses. This significant milestone, set to take effect January 1, 2026, marks a transformative step in the recognition and reimbursement of AI-driven technologies aimed at improving patient outcomes in cardiovascular care.

Several Medicare Administrative Contractors (MACs) have officially approved Artificial Intelligence-enabled Quantitative Coronary Topography (AI-QCT) scans for Medicare recipients with stable and acute symptoms suspicious of coronary artery disease. Cleerly, the company on a mission to eradicate heart attacks, requested the decision on MAC coverage in February of 2023 to expand coverage of potentially life-saving AI technology to Medicare recipients at risk for future heart attacks.

Cleerly, the company on a mission to create a new standard of care to aid in the diagnosis of heart disease, shared findings from a study published online in the Journal of the American College of Cardiology: Cardiovascular Imaging on March 13, 2024. The study describes the validation of Cleerly's artificial intelligence-guided quantitative coronary CT angiography (AI-QCT) ISCHEMIA technology for diagnostic accuracy and prognostic risk stratification.

Cleerly, the company on a mission to create a new standard of care to aid in the diagnosis of heart disease, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its Coronary Artery Disease (CAD) Staging System. The CAD Staging System is a noninvasive imaging-based investigational software device that analyzes important and actionable features of coronary atherosclerosis, stenosis and ischemia. Its purpose is to support physicians with a more accurate and personalized risk assessment for patients at risk of major adverse cardiovascular events (MACE), including heart attacks, before they happen.

Cleerly, the company creating a new standard of care to aid in the diagnosis of heart disease, announced that its recently U.S. Food and Drug Administration (FDA)-cleared Cleerly ISCHEMIA software device applied to a non-invasive coronary CT angiogram (CCTA) can be billed using the new Category I CPT® code 75580. The American Medical Association (AMA) defines this service as a complementary augmented intelligence tool for noninvasive estimates of fractional flow reserve (FFR) to assist healthcare professionals in clinical diagnosis and decision making. The Category I CPT® code is an addition to the Category III CPT® codes (CPT® 0623T, 0624T, 0625T, 0626T) used for reporting Cleerly’s advanced coronary atherosclerosis analysis.

Cleerly, the company working to create a new standard of care to aid in the diagnosis of heart disease, announced continued strong scientific evidence supporting the clinical utility of its products.

Cleerly, the company working to create a new standard of care for the diagnosis of heart disease, today announced the launch of Cleerly ISCHEMIA, which recently received U.S. Food and Drug Administration (FDA) 510(k) medical device clearance. Cleerly ISCHEMIA analysis software is an automated machine learning-based decision support tool, intended as a diagnostic aid for patients undergoing coronary computed tomography angiography (CCTA) analysis using Cleerly Labs software.

Cleerly, the company working to create a new standard of care for the diagnosis of heart disease, today announced the TRANSFORM trial at the American Heart Association’s (AHA) 2023 Scientific Sessions. TRANSFORM is a randomized trial – sponsored by Cleerly – that aims to enroll 7,500 patients who have pre-diabetes, type 2 diabetes, or metabolic syndrome and have no symptoms of heart disease. TRANSFORM aims to prove that a personalized care strategy based on a Cleerly analysis is better than usual care based on traditional cardiovascular risk factors for the primary prevention of cardiovascular events.

Cleerly, the company creating a new standard of care for heart disease, is proud to announce its selection as the winner of the Best Use of AI in Health Tech Award presented by The Digital Health Hub Foundation in the Best in Class track at the 2023 HLTH conference, one of the largest digital health meetings internationally.

Cleerly, the company creating a new standard of care for heart disease, today announced that it has been named “Best Overall AI Solution” in the sixth annual AI Breakthrough Awards program conducted by AI Breakthrough, a leading market intelligence organization that recognizes the top companies, technologies and products in the global Artificial Intelligence (AI) market today.

Cleerly, the company creating a new standard of care for heart disease, announced today it has appointed Krissy Wright as Chief Financial Officer (CFO) and Sandra Statz as Executive Vice President of Regulatory Affairs. In her role, Wright will provide financial supervision to the business and ensure adherence. Statz will oversee global regulatory strategy and submissions in compliance with applicable regulatory requirements and in alignment with Cleerly’s goals.

Cleerly, the company creating a new standard of care for heart disease, announced it will be presenting a number of new research studies at the American College of Cardiology’s Annual Scientific Session & Expo and the World Heart Federation’s World Congress of Cardiology (ACC.23/WCC) at the Ernest N. Morial Convention Center in New Orleans, LA, March 4-6. Onsite, Cleerly executives will share new clinical evidence championing the accuracy and effectiveness of using AI-enabled coronary computed tomography angiography (CCTA) to guide personalized evaluation and treatment of coronary artery disease.

Cleerly, the company creating a new standard of care for heart disease, announced it has appointed Udo Hoffmann, MD, MPH, as chief scientific officer. In this role, Dr. Hoffmann will oversee Cleerly’s large-scale research efforts, including its multicenter clinical trials, as well as Cleerly’s relationships with other leading healthcare industry partners.

Cleerly, the company creating a new standard of care for heart disease, and Heartbeat Health, the nation's largest virtual-first cardiovascular company, today announced a partnership to use precision heart health to more accurately determine cardiovascular risk and deliver better heart care.

Cleerly, the company creating a new standard of care for heart disease, announced a new workflow solution to its portfolio, Proxy. Cleerly Proxy is a software that allows Cleerly to seamlessly transmit data to care providers by automating the upload of coronary computed tomography angiography (CCTA) scans from local systems to Cleerly’s cloud service. The pre-hardened virtual machine can be installed and configured in minutes to save time and reduce security risks for each Cleerly heart analysis.

Cleerly, the company creating a new standard of care for heart disease, announced it has appointed Joseph “Joe” Jasser, MD, as chief of value based care. In this role, Dr. Jasser will be responsible for developing and executing the initial business plan and go-to-market strategy for the value-based care client segment. He will also lead the commercial and client services teams for Cleerly's Value Based Care vertical, and will report to Jim Hartman, chief revenue officer of Cleerly.

Cleerly, the company creating a new standard of care for heart disease, announced that it has closed a Series C financing round of $192 million. This new funding brings the total raised by the fast-growing health care company to $248 million, which includes its Series B round in 2021.

Cleerly, the company creating a new standard of care for heart disease, announced its latest product release, Cleerly 2.2.0, that includes user experience (UX) refinements and three new high-value tools. These updates come in the midst of American Heart Month and allow Cleerly technology to enter into the clinical workflows of health systems and providers across the U.S., drive new efficiencies, and deliver new insights to customers.

Cleerly, the company creating a new standard of care for heart disease, announced that New York City Health Business Leaders (NYCHBL), the organization that serves as the gateway to New York’s healthcare ecosystem, has recognized the company on its NYC Digital Health 100, showcasing the most exciting and innovative health start-ups in New York.

Cleerly, the company creating a new standard of care for heart disease, announced today it has expanded its board of directors with three new medical and investment leaders. Kevin M. King, Glenn D. Steele Jr., MD, PhD and Roy Beveridge MD have joined the board to advise the company as it works to identify individuals at the earliest stage to prevent heart attacks and save lives with its digital care pathway solution.

Cleerly, the company creating a new standard of care for heart disease, announced today it has appointed Jim Hartman as Chief Revenue Officer. In this role, Jim will be responsible for driving the company’s revenue-generation strategy and execution, globally. He will lead the sales, payer, implementation, customer success and partnership channel teams, and will report to James K. Min, MD FACC, founder and CEO of Cleerly.

Cleerly, the company creating a new standard of care for heart disease, announced today it has appointed Brandon Atkinson as Chief Operating Officer (COO) and Nick Nieslanik as Chief Technology Officer (CTO). These strategic executive hires follow Cleerly closing its $43 million series B round this summer and will enable the company to accelerate its work to identify individuals at the earliest stage to prevent heart attacks and save lives with its digital care pathway solution.

Cleerly, the company creating a new standard of care for heart disease, launched today with $43 million in Series B funding and unveiled its first-of-its-kind digital care pathway solution for heart attack prevention. The financing, which was led by Vensana Capital with participation from LRVHealth, New Leaf Venture Partners, DigiTx Partners, the American College of Cardiology, Cigna Ventures, and existing investors, brings Cleerly’s total funding to $54 million.