Welcome to our dedicated page for Acarix AB news (Ticker: ACIXF), a resource for investors and traders seeking the latest updates and insights on Acarix AB stock.
Acarix AB (ACIXF) is a Swedish medical device company specializing in non-invasive, AI- and acoustics-based cardiac diagnostics. Most company news centers on its flagship CADScor System, a CE-marked and FDA De Novo-cleared diagnostic aid designed for rapid rule out of significant coronary artery disease (CAD) at the point of care in patients with chest pain.
News updates for Acarix often highlight clinical and health-economic evidence for the CADScor System. For example, peer-reviewed research has examined a “CADScor-first” strategy in US emergency departments, reporting that using the system as an initial diagnostic tool for low-risk chest pain patients can reduce costs compared with standard non-invasive imaging while maintaining diagnostic safety. Other articles discuss the system’s reported high negative predictive value and its use in tens of thousands of patients.
Investors and clinicians following ACIXF can also expect announcements about regulatory and reimbursement developments. Acarix has reported that the CADScor System’s CPT code has been assigned to an APC with a separately payable status indicator by the US Centers for Medicare & Medicaid Services, enabling standalone fixed reimbursement in certain outpatient and emergency settings. Such decisions are described by the company as important for accelerating CADScor adoption in the US.
Additional news themes include commercial expansion, financial results, and strategic partnerships. Acarix has communicated growth in CADScor system placements and patch sales, record gross profit periods, and the use of a consignment-based model in the US. The company has also announced a partnership with Geo-Med, LLC to extend CADScor availability to US veterans, and recognition from the Global Cardiovascular Awards for digital innovation in cardiac imaging. For investors and healthcare professionals, the Acarix news feed provides ongoing insight into clinical validation, market access, and commercialization progress for the CADScor System.
Acarix (symbol ACIXF) announced that its CADScor®System achieved EU MDR (2017/745) certification on February 4, 2026, confirming compliance with the EU's highest safety, quality and clinical performance requirements.
This regulatory milestone enables continued and expanded access across European markets, supports accelerated commercial adoption and clinical use, and reinforces the company's pathway to broaden adoption, including planned efforts toward U.S. market expansion.
Acarix (OTC:ACIXF) announces a new peer-reviewed study published in PharmacoEconomics – Open highlighting the cost-effectiveness of its CADScor® System in U.S. emergency departments. The study, conducted by the Baim Institute for Clinical Research, demonstrates that implementing a "CADScor-First" strategy could save hospitals between $7.3M and $15.3M per 10,000 patients while maintaining diagnostic safety.
The FDA-cleared device features a 96.2% negative predictive value for ruling out coronary artery disease in under 10 minutes at point of care. The system showed consistent economic value across disease prevalence rates of 2-30%, with minimal difference in missed cardiac events (fewer than 0.0002 additional events per patient) compared to standard care.
Acarix has been awarded the 2025 Digital Innovation Award at the Global Cardiovascular Awards in London for its CADScor® System. The company also received an honorable mention for Innovation in Cardiac Imaging.
The CADScor System represents a breakthrough in early cardiac diagnostics, utilizing non-invasive AI and acoustic technology for rapid coronary artery disease (CAD) risk assessment. The system achieves over 96% certainty in low risk stratification, helping reduce unnecessary procedures and optimize patient care pathways.
The Global Cardiovascular Awards, judged by international experts including CEOs and clinical leaders, recognizes innovations making measurable impacts on global cardiovascular health.
Acarix reported strong financial results for 2024, marked by significant growth in its U.S. operations. The company achieved a 333% increase in system placements and an 88% surge in patch sale revenue in Q4 2024 compared to Q4 2023. Total revenue for Q4 reached SEK 1,700 thousand, up 45% year-over-year.
The company delivered 62 CADScor systems throughout 2024, a 51% increase from 2023, with 60 systems deployed in the U.S. market. Patch sales grew 27% annually, reaching 11,734 units. The gross margin improved to 90%, up 5 percentage points from 2023. Operating costs decreased by 27% in Q4, and the company reduced its adjusted loss by 32% compared to the previous year.
A favorable CMS ruling allowing standalone fixed reimbursement for the CADScor System in outpatient settings positions Acarix for significant U.S. growth in 2025. The company also secured strategic partnerships, including with Geo-Med, , to expand the CADScor System's reach to U.S. Veterans.
Acarix has announced a strategic partnership with Geo-Med, , a Service-Disabled Veteran-Owned Small Business, to expand the availability of its CADScor System within federal medical facilities serving veterans. The partnership aims to enhance access to advanced cardiac diagnostic technology through the Department of Veterans Affairs and Department of Defense.
The CADScor System, known for its acoustic-based cardiac diagnostic capabilities and accurate low-risk stratification in assessing coronary artery disease (CAD) at the point of care, will become more accessible to veterans through Geo-Med's established expertise in VA procurement and distribution of medical products.
Acarix announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has assigned CPT code 0716T for the CADScor System to APC 5733 with 'S' (separately payable) status for 2025. This decision enables standalone fixed reimbursement for CADScor in outpatient settings, including emergency rooms and ambulatory surgery centers. The CADScor System is a non-invasive, AI-powered diagnostic tool that rules out Coronary Artery Disease with 97% accuracy in under 10 minutes. The system is FDA-cleared, CE-marked, protected by over 40 patents, and has been used on more than 40,000 patients with symptomatic chest pain.
Acarix AB, a leader in AI-based cardiac diagnostics, reported strong Q2 2024 financial results. Key highlights include:
- Revenue increased 27% to SEK 1,958 thousand
- Gross profit rose 38% to SEK 1,788 thousand (91% margin)
- 15 CADScor Systems installed (2 sold, 13 consigned)
- 3,530 patches sold (62% increase in US)
- Operating costs reduced by 25% (excluding one-time expenses)
- Loss before tax: SEK –16,661 thousand
For H1 2024, revenue was SEK 3,509 thousand, with 28 CADScor Systems and 6,054 patches sold. The company's cash position stood at SEK 48,271 thousand. These results reflect Acarix's growing market presence and successful implementation of its new sales model and strategic initiatives.
Acarix, a leader in AI and acoustics-based cardiac diagnostics, has begun trading on the US-based OTCQB Market under the ticker symbol ACIXF. This move allows Acarix shares to be traded in USD alongside its existing Nasdaq First North Growth market listing in Stockholm. The OTCQB Market, operated by OTC Markets Group, serves as an alternative to Nasdaq New York and NYSE listings for 12,000 US and global securities.
CEO Aamir Mahmood expressed excitement about expanding the company's reach beyond the Stockholm listing, particularly as the US is Acarix's most important commercial market. The OTCQB listing is expected to increase accessibility to US capital markets and satisfy growing interest from US investors. Companies listed on OTCQB must meet high financial standards, follow best practice corporate governance, and demonstrate compliance with US securities laws.