Cardiovascular Devices Market to Surpass $113.2B by 2031, Driven by Tech & M&A Surge
DataM Intelligence forecasts 8.1% CAGR for cardiovascular devices market, fueled by innovation, FDA wins, and global strategic investments.
The convergence of AI, minimally invasive tech, and strategic funding is redefining cardiovascular care.”
LOS ANGELES, CA, UNITED STATES, July 24, 2025 /EINPresswire.com/ -- DataM Intelligence estimates the cardiovascular devices market at roughly US $61.5 billion in 2023, expanding to around US $113.2 billion by 2031, at a CAGR of 8.1% from 2024 to 2031.— DataM Intelligence
DataM Intelligence Perspective | 2025 Update:
The global cardiovascular devices market is undergoing a transformational shift, driven by a confluence of demographic, clinical, and technological forces. As cardiovascular diseases (CVDs) remain the leading cause of mortality worldwide, the demand for advanced diagnostic and therapeutic solutions continues to surge. From DataM Intelligence’s analysis, the market is not just expanding in size but evolving in complexity, technological integration, and regional dynamics.
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Key Market Drivers:
Rising disease burden: With heart disease increasingly prevalent driven by aging populations and lifestyle-related risk factors healthcare systems are turning to innovative cardiovascular treatments.
Procedural advances: The shift toward minimally invasive therapies, such as transcatheter valves, catheter-based ablations, and robotic-assisted interventions, bolsters device demand.
Technological innovation: Emerging tech AI-enhanced monitoring, bioresorbable implants, and portable cardiac sensors are advancing diagnosis, treatment precision, and patient convenience.
Regulatory balance: While high regulatory standards (FDA, EMA) ensure device safety and efficacy, they also introduce approval delays and complexity.
Regional Highlights:
North America: Leads with strong healthcare infrastructure, innovation, and high cardiovascular disease prevalence. In the U.S. alone, over 82 million people live with one or more cardiovascular conditions.
Asia-Pacific: The fastest-growing region, driven by rising CVD incidence, expanding healthcare access, and accelerated adoption of advanced therapies.
Market Segments:
• By Diagnostic and Monitoring Devices (Electrocardiogram, Remote Cardiac Monitoring, Others)
• By Therapeutic and Surgical Devices (Ventricular Assist Devices (VAD), CRM Devices, Catheters, Stents, Heart Valves, Others)
• By Application (Coronary Artery Diseases, Cardiac Arrhythmia, Heart Failure, Others)
• By End User (Hospitals, Specialty Clinics, Others)
• By Region (North America, Europe, South America, Asia-Pacific, Middle East and Africa)
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FDA Approvals & Breakthrough Designations:
• Inquis Medical's Aventus System received expanded FDA approval in June 2025 for treating pulmonary embolism, broadening catheter-based PE intervention options.
• Bivacor’s Total Artificial Heart was granted FDA breakthrough device designation in early June 2025, accelerating its path to clinical trials.
• EBR Systems’ WiSE System achieved FDA approval in April 2025 as the first leadless left ventricular endocardial pacing therapy for heart failure patients unable to receive lead-based CRT devices.
• Orchestra BioMed’s AVIM therapy, a pacemaker-based system for hypertension, also received Breakthrough Device designation in April 2025.
• The FDA’s CDRH 2025 guidance agenda emphasizes frameworks for AI, cybersecurity, and emerging tech key for cardiovascular device developers.
Strategic Investments in Cardiovascular Devices (2025):
• July 21, 2025: The Abu Dhabi Investment Authority (ADIA) committed US $200 million for a 3% equity stake in Micro Life Sciences (Meril), valuing the company at approximately US $6.6 billion. This underscores mounting investor confidence in India’s growing medtech segment, particularly cardiovascular intervention devices like Myval and MyClip.
• Q1 2025: Stryker acquired Inari Medical for US $4.9 billion, expanding its thrombectomy and PE/DVT treatment portfolio (FlowTriever, ClotTriever).
• Boston Scientific purchased Bolt Medical (IVL platform) and SoniVie (renal denervation system for hypertension), worth up to $600 million and $400 million, respectively, further enhancing its cardiovascular pipeline.
• March 2025: Supira Medical raised US $120 million to advance its percutaneous ventricular assist device (pVAD) for high-risk PCI and cardiogenic shock indications, supporting its SUPPORT II pivotal trial toward FDA PMA submission.
CES 2025 Innovations - At CES in Las Vegas (January 7–10, 2025):
• Withings launched Cardio Check‑Up (virtual cardiologist consults on ECG data) on Jan 7, 2025, and previewed BPM Vision, an accessible home-use blood pressure monitor due for FDA clearance by April 2025.
• FaceHeart unveiled CardioMirror, an AI-powered smart mirror capable of heart rate, blood pressure, and AFib warning detection via remote photoplethysmography.
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Sai Kiran
DataM Intelligence 4Market Research
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