Peer-Reviewed Study Confirms CADScor System Can Diagnose Heart Failure With Far Fewer False Positives Than Standard Blood Test
Acarix’s CADScor platform showed exploratory heart failure diagnostic performance with fewer false positives than NT-proBNP but still needs validation.
Rhea-AI Summary
Acarix (ACIXF) reported that an Aalborg University-led study in PLOS Digital Health found the CADScor System’s seismocardiography technology can detect heart failure with performance comparable to a standard NT-proBNP blood test, while generating far fewer false positives.
In 218 enrolled patients, machine-learning algorithms produced an AnyHF-score with 90.9% sensitivity and 87.5% negative predictive value for any-type heart failure. For reduced ejection fraction (HFrEF), the HFrEF-score achieved diagnostic accuracy similar to NT-proBNP (92.9% vs. 94.7% AUC) and similar sensitivity, but substantially higher specificity (92% vs. 68.8%) and more than doubled positive predictive value (57.7% vs. 27.1%). SCG-based scores labeled 51% of 139 non-HF referrals as “minimal risk,” suggesting potential to reduce unnecessary echocardiograms. The heart failure algorithm is built into Acarix’s Gen 2 device but remains investigational, requiring larger external validation and FDA approval.
Positive
- AnyHF-score sensitivity 90.9% and negative predictive value 87.5% for any-type heart failure
- HFrEF-score AUC 92.9% vs. NT-proBNP 94.7%, indicating comparable diagnostic accuracy
- Specificity 92% vs. 68.8% for HFrEF-score compared with NT-proBNP (p<0.001)
- Positive predictive value 57.7% vs. 27.1% for HFrEF-score compared with NT-proBNP (p=0.007)
- 51% of 139 non-HF referrals classified as “minimal risk,” indicating potential to cut unnecessary echocardiograms
- HF algorithm integrated into CADScor Gen 2 device, expanding potential use beyond CAD
Negative
- Exploratory feasibility study with a relatively small sample of 218 patients at two centers
- Heart failure algorithm is investigational and not yet approved by the FDA
- External validation in larger independent cohorts required before broader clinical use
- FDA submission will likely require a larger validation trial than the current study
AI-generated analysis. How Rhea-AI works. Not financial advice.
Aalborg University-led research, published in PLOS Digital Health, found the CADScor System's acoustic sensing platform identified heart failure with diagnostic accuracy comparable to a leading blood test, and with significantly fewer false positives
Heart failure affects millions of people worldwide and is a leading cause of hospitalization, yet it can be difficult to diagnose quickly. Guideline-recommended tools such as echocardiography and NT-proBNP blood testing are effective but come with real-world limitations, including long imaging wait times, operator-dependent results, and blood biomarkers that can be elevated for reasons unrelated to the heart. The study explored whether SCG, which uses a small accelerometer to capture the chest's vibrations from each heartbeat, could help close that gap.
"Heart failure and coronary artery disease are the two biggest reasons patients end up in front of a cardiologist, and this new research opens up a whole new frontier for our CADScor System," said Aamir Mahmood, Chief Executive Officer of Acarix. "We built CADScor to give clinicians a fast, accurate, first-line tool for cardiac triage, and these results show we can bring that same value to heart failure, one of the most common and costly diagnoses in cardiology. That is a significant expansion of what CADScor can do for patients and for our business."
Researchers enrolled 218 patients: 198 referred by their general practitioners for suspected heart failure, plus an additional 20 patients with previously confirmed HFrEF enrolled separately to strengthen testing of the algorithm. Using machine learning, the team developed two SCG-based algorithms: an "AnyHF-score" to flag heart failure of any type, and an "HFrEF-score" to specifically identify heart failure with reduced ejection fraction (HFrEF), the most severe form of the condition.
The study found that:
- The AnyHF-score detected heart failure of any type with
90.9% sensitivity and an87.5% negative predictive value, correctly flagging the large majority of patients who did have the condition. - The HFrEF-score performed comparably to NT-proBNP, the current standard blood test, in identifying reduced heart function, with similar diagnostic accuracy (
92.9% vs.94.7% AUC) and sensitivity, but with significantly higher specificity (92% vs.68.8% , p<0.001) and a more than doubled positive predictive value (57.7% vs.27.1% , p=0.007), meaning far fewer false alarms. - The SCG-based scores identified 71 of 139 patients (
51% ) referred for suspected heart failure but ultimately found not to have the condition as "minimal risk," pointing to a potential role for SCG in helping clinicians reduce unnecessary echocardiogram referrals.
The authors describe the results as exploratory, noting that the study was conducted in a relatively small population at two centers and that the algorithms will require external validation in larger, independent cohorts before broader clinical use. The HF algorithm is investigational and has been built into the mechanics of Acarix's Gen 2 device, but it is not yet approved by the FDA. Acarix will need to submit the HF algorithm for FDA approval, a process that will likely require a larger validation trial than the current feasibility study.
The research titled, "A feasibility study evaluating seismocardiography for the detection of heart failure," was authored by researchers at Aalborg University Hospital, Aarhus University Hospital and Odense University Hospital in
About the CADScor®System
The CADScor System is a point-of-care diagnostic aid that uses highly sensitive acoustics and advanced computational analysis and AI to assess a patient's coronary blood flow. It calculates a patient-specific CAD-score and combines it with clinical risk factors to rapidly indicate the risk of significant coronary stenosis, prior to potential secondary evaluation. The system produces a result in under 10 minutes and is designed to rule out significant CAD with at least
About Acarix
Acarix is a Swedish medical device company that innovates solutions for rapid rule out of coronary artery disease (CAD) at point of care. The CE-approved and FDA DeNovo-cleared Acarix CADScor®System is intended for patients experiencing chest pain with suspected CAD and designed to help reduce millions of unnecessary, invasive, and costly diagnostic procedures. The CADScor®System has been used on more than 60,000 patients. Acarix recommends CADScor®System as a first-line diagnostic aid that uses highly sensitive acoustics and advanced computational processing to analyze coronary blood flow to rule out significant coronary artery disease (CAD), with at least
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FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What patient population and study design were used to test the CADScor HF algorithms?
The study enrolled 218 patients: 198 referred by general practitioners for suspected heart failure and 20 with previously confirmed heart failure with reduced ejection fraction (HFrEF) who were added separately to strengthen algorithm testing. Researchers used seismocardiography recordings and machine learning to develop two scores: an AnyHF-score for any-type heart failure and an HFrEF-score specifically for reduced ejection fraction.
How might the SCG-based scores affect use of echocardiography in suspected heart failure?
The SCG-based scores identified 71 of 139 patients referred for suspected heart failure but ultimately found not to have the condition (51%) as “minimal risk.” The authors suggest this points to a potential role for seismocardiography in helping clinicians reduce unnecessary echocardiogram referrals.
What is the current regulatory status of the CADScor heart failure algorithm?
The heart failure algorithm has been built into the mechanics of Acarix’s second-generation CADScor device but remains investigational. It is not yet approved by the FDA. Acarix will need to submit the algorithm for FDA approval, which the company expects will require a larger validation trial than this feasibility study.
Where and by whom was the heart failure feasibility study conducted and published?
The research, titled “A feasibility study evaluating seismocardiography for the detection of heart failure,” was conducted by researchers at Aalborg University Hospital, Aarhus University Hospital and Odense University Hospital in Denmark. It was funded by Acarix and published in the journal PLOS Digital Health, with the article available at journals.plos.org/digitalhealth.
What existing approvals and usage does the CADScor System already have for coronary artery disease?
The CADScor System is CE-marked under EU MDR 2017/745 and has FDA De Novo clearance as a diagnostic aid for symptomatic patients with suspected coronary artery disease (CAD). It is designed to rule out significant CAD at point of care with at least 96% negative predictive value and has been used in more than 60,000 patient assessments.