CardioWise's FDA-cleared SQuEEZ™ software extracts a quantitative picture of how well the heart muscle is working from the cardiac CT scans hospitals are already performing, with no new hardware, no new scan protocol, and results in about a minute.
Heart disease remains America's leading cause of death. In 2024 it claimed 683,037 lives in the United States, and cardiovascular disease kills one American roughly every 33 seconds. The direct cost to the U.S. healthcare system runs to about $223 billion a year.
Despite the scale of the problem, the diagnostic path for a patient with suspected coronary disease is still slow and fragmented. An emergency work-up can take 22 to 24 hours before a treatment decision is made. Patients frequently move through several tests, with a typical work-up costing around $3,600, and even after intervention, clinicians often lack objective, quantitative measures to guide follow-up care.
A Scan Whose Moment Has Arrived
Coronary CT angiography (CCTA) has quietly become one of the most important tests in cardiology. In 2021, the ACC/AHA chest pain guideline gave CCTA a Class 1, Level A recommendation as a first-line test for both stable and acute chest pain, the strongest evidence rating a test can receive. Volume grew 44% in the twelve months that followed, and Medicare's CCTA rate had already more than doubled between 2010 and 2022. CCTA is now projected to overtake stress echocardiography in the Medicare population.
Every one of those scans captures the beating heart in three dimensions. Yet today, most of the analysis focuses on the coronary arteries: where the blockages are, how much plaque has built up, and whether blood flow is restricted. What the scan can also reveal, but rarely does, is how the heart muscle itself is performing.
What SQuEEZ Does Differently
CardioWise, a Fayetteville, Arkansas company and VIC Tech portfolio company, built SQuEEZ to fill that gap. The software measures regional myocardial strain, meaning how well each segment of the heart wall contracts, directly from a standard cardiac CT.
The workflow is simple. A cardiac CT is acquired as usual, and the images upload automatically to the cloud. SQuEEZ analyzes the heart's motion and compares it against a database of confirmed normal hearts, and within about a minute the cardiologist or radiologist receives a two-page quantitative report through PACS or email. That report shows global and segment-level function, the timing of peak contraction, and any mechanical delay between regions. Because the heart segments are mapped to the coronary artery that supplies each one, abnormal motion can point clinicians toward the vessel involved.
Myocardial strain is not a new or unproven concept. It is backed by more than two decades of clinical evidence as a marker of heart function. What CardioWise has done is make it available from a scan that is already being performed, rather than requiring a separate test.
Seeing What Echo Misses
The value of this becomes clear in heart failure. Roughly half of heart failure patients have what is called preserved ejection fraction (HFpEF). In these patients, the standard echocardiogram measure of pumping function looks normal, even though the disease is present. SQuEEZ evaluates the heart segment by segment, which allows it to reveal abnormal wall motion that a single global number can hide.
The platform has been studied across six cardiac indications, including chest pain, HFpEF, pulmonary embolism, pulmonary hypertension, and TAVR planning, with validation work at institutions including Emory, the NIH, UC San Diego, Georgetown, and King's College London.
A Second Application With Immediate Impact
CardioWise's second licensed technology, the Image Toolbox for cardiac resynchronization therapy (CRT), addresses a costly problem in device cardiology. About 60,000 CRT devices are implanted in the U.S. each year, yet 30 to 40% of patients do not respond to the therapy, representing more than $1 billion in annual spending on procedures that fail to help.
The Toolbox uses SQuEEZ to identify the optimal pacing target before the implant. In a Medtronic-sponsored pilot, placing the lead at a SQuEEZ-identified target produced a response in more than 90% of cases, compared with about 60% for non-targeted placement. The goal is to prevent non-response rather than manage it after the fact.
Complementary to the Coronary Leaders
The cardiac CT analysis market has already produced a public company. HeartFlow, which analyzes the coronary arteries, now trades on NASDAQ, and companies such as Cleerly and Elucid are focused on plaque and stenosis. CardioWise does not compete with these players. They read the arteries; SQuEEZ reads the heart muscle, adding functional information to the same scan. Strain analysis exists on echo and MRI, but CardioWise holds exclusive Johns Hopkins IP for doing it from CT.
De-Risked and Ready to Scale
Many medtech startups spend years working through the most expensive and uncertain milestones. CardioWise has cleared them. SQuEEZ received FDA 510(k) clearance in December 2020, the company holds ISO 13485 quality system certification, and its core technology is protected by two patents exclusively licensed from Johns Hopkins.
Because SQuEEZ runs as software on scans hospitals already perform, CardioWise can reach customers through the platforms they already use. The company has a distribution agreement with GE HealthCare, one of the world's largest CT manufacturers, under which SQuEEZ is available on GE's CardIQ cardiac CT platform. Additional scanner, PACS, and analysis-platform partners extend that reach, and CardioWise is building a dedicated commercial team focused on hospital systems with established cardiac CT programs and cardiology practices with on-site CT.
Next on the roadmap are commercial launch, CE Mark for European markets, and an application to AMA for a new-technology CPT code. Behind those near-term milestones sits a longer-term data strategy: every scan analyzed strengthens the normal-hearts database, allowing the company to define "normal" by patient group, track the same heart across time, and eventually link strain measurements to patient outcomes for predictive risk assessment.
Cardiac CT has become a front-line test for the world's leading cause of death. CardioWise is making sure every one of those scans tells clinicians not only what the arteries look like, but how the heart is actually working.
CardioWise will be presenting at our October 28th VIN Webinar, Register to learn more.