Cardiovascular Business

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Cardiology operations, devices and technology in care delivery

Acute Kidney Injury After TAVR: Key Risk Factors Every Cardiologist Should Know
NewsMar 18, 2026

Acute Kidney Injury After TAVR: Key Risk Factors Every Cardiologist Should Know

A meta‑analysis of 10,353 transcatheter aortic valve replacement (TAVR) patients found that 21.7% develop acute kidney injury (AKI). The study identified eight independent predictors, including hypertension, coronary artery disease, peripheral vascular disease, prior stroke, chronic kidney disease, elevated serum creatinine,...

By Cardiovascular Business
FDA Approves JenaValve TAVR System for Aortic Regurgitation
NewsMar 18, 2026

FDA Approves JenaValve TAVR System for Aortic Regurgitation

JenaValve received FDA clearance for its Trilogy Transcatheter Heart Valve System, marking the first TAVR device expressly approved to treat symptomatic, severe aortic regurgitation (AR). The approval follows the ALIGN‑AR trial, which demonstrated the valve’s safety and efficacy in a...

By Cardiovascular Business
New Obesity Statistics Highlight Importance of Preventive Cardiology
NewsMar 16, 2026

New Obesity Statistics Highlight Importance of Preventive Cardiology

A new WalletHub analysis ranks Little Rock, Arkansas as the nation’s most overweight city, followed by McAllen, Texas and Memphis, Tennessee. The report evaluated 100 U.S. metro areas on adult and child obesity, cardiovascular health, food access and fitness, confirming...

By Cardiovascular Business
Imaging Evaluations and PCI Planning: Heartflow Announces ‘Tremendous Progress’ for AI Portfolio
NewsMar 16, 2026

Imaging Evaluations and PCI Planning: Heartflow Announces ‘Tremendous Progress’ for AI Portfolio

Heartflow announced that its AI‑enabled Plaque Analysis software will be highlighted in three ACC.26 presentations, showcasing data from a 15,000‑patient CCTA registry that predicts major adverse cardiovascular events. A separate DECIDE registry of nearly 3,800 patients demonstrated that AI‑guided care...

By Cardiovascular Business
Heart Failure Hospitalizations After PCI: A Warning Sign of ‘Exceptionally High Risk’
NewsMar 16, 2026

Heart Failure Hospitalizations After PCI: A Warning Sign of ‘Exceptionally High Risk’

A new JACC: Cardiovascular Interventions study of over 10,000 PCI patients in Japan found that heart‑failure hospitalizations occur in 4.7% of cases and are linked to a 25% two‑year mortality rate. By contrast, acute coronary syndrome and major bleeding showed...

By Cardiovascular Business
New Dyslipidemia Guideline Puts Add-On Testing, Early Screening in the Spotlight
NewsMar 13, 2026

New Dyslipidemia Guideline Puts Add-On Testing, Early Screening in the Spotlight

The latest dyslipidemia guideline introduces the PREVENT risk calculator, enabling clinicians to personalize ASCVD risk using routine health data and specific risk enhancers. It expands recommendations to include non‑contrast coronary artery calcium scans, as well as Lp(a) and apoB testing,...

By Cardiovascular Business
CRT 2026: Key Takeaways for Interventional Cardiologists
NewsMar 13, 2026

CRT 2026: Key Takeaways for Interventional Cardiologists

The Cardiovascular Research Technologies (CRT) 2026 meeting showcased a suite of late‑breaking interventional cardiology studies, ranging from long‑term TAVR versus SAVR outcomes to novel radiation‑shielding devices. A seven‑year PARTNER 3 substudy found comparable health‑status results for low‑risk patients after TAVR and...

By Cardiovascular Business
Apixaban Bests Rivaroxaban in New DOAC Comparison
NewsMar 12, 2026

Apixaban Bests Rivaroxaban in New DOAC Comparison

A head‑to‑head trial (COBRRA) of 2,700 acute VTE patients found apixaban significantly lowers bleeding risk compared with rivaroxaban, while maintaining similar efficacy in preventing recurrent clots. Patients received standard dosing regimens for three months, with apixaban showing a 3.3% composite...

By Cardiovascular Business
Prior Authorization May Reduce Access to Important Heart Failure Drugs
NewsMar 12, 2026

Prior Authorization May Reduce Access to Important Heart Failure Drugs

A new JACC: Advances study finds prior‑authorization requirements hinder access to guideline‑recommended heart‑failure drugs, affecting 12.2% of ARNI and 14.3% of SGLT2i prescriptions. The barriers are disproportionately faced by younger, Black and Hispanic patients with non‑Medicare insurance. Authorization delays extend...

By Cardiovascular Business
FDA Clears Intravascular Device Billed as ‘World’s Smallest Camera’ as Physicians Share New Data
NewsMar 12, 2026

FDA Clears Intravascular Device Billed as ‘World’s Smallest Camera’ as Physicians Share New Data

Vena Medical secured FDA clearance for its Vena MicroAngioscope System, marketed as the world’s smallest intravascular camera, for peripheral artery imaging. The device provides real‑time color images without X‑ray fluoroscopy by pairing a balloon distal access catheter with a saline...

By Cardiovascular Business
Shortage of Cardiac Amyloidosis Radiotracers Should Ease in Late March
NewsMar 11, 2026

Shortage of Cardiac Amyloidosis Radiotracers Should Ease in Late March

The American Society of Nuclear Cardiology (ASNC) announced that the nationwide shortage of technetium‑99m radiotracers used to diagnose transthyretin cardiac amyloidosis is expected to ease by late March. Curium, a key supplier, has already released a PYP lot in mid‑February...

By Cardiovascular Business
FDA Clears New Large-Bore Catheter for Challenging Stroke Cases
NewsMar 11, 2026

FDA Clears New Large-Bore Catheter for Challenging Stroke Cases

Toro Neurovascular has obtained FDA clearance for its Toro 88 Superbore Catheter, a large‑bore device engineered for challenging stroke interventions. The catheter promises enhanced support, trackability, and stability, addressing the time‑sensitive nature of neurovascular procedures. UCLA interventional neuroradiologist Dr. Satoshi Tateshima...

By Cardiovascular Business
Vascular Surgeons Deliver Major Value in Terms of Patient Outcomes and Health System Profitability
NewsMar 11, 2026

Vascular Surgeons Deliver Major Value in Terms of Patient Outcomes and Health System Profitability

A new meta‑analysis of 29 clinical trials shows that involving vascular surgeons in multidisciplinary care consistently improves patient outcomes, including lower blood loss, fewer complications, and reduced amputation rates. The studies also reveal a strong financial upside: vascular surgery contributes...

By Cardiovascular Business
A ‘Disquieting Plateau’: Healthcare Costs Are up, but Survival Among Heart Patients Stays the Same
NewsMar 11, 2026

A ‘Disquieting Plateau’: Healthcare Costs Are up, but Survival Among Heart Patients Stays the Same

A new JACC analysis shows that U.S. cardiovascular mortality, which fell sharply from 2000 to 2011, has essentially stalled since 2011, hovering around 224 deaths per 100,000. During the same period, spending on cardiovascular care more than tripled, rising from...

By Cardiovascular Business
Shockwave Medical’s New Coronary IVL Catheter, Now Twice as Fast, Impresses After 30 Days
NewsMar 10, 2026

Shockwave Medical’s New Coronary IVL Catheter, Now Twice as Fast, Impresses After 30 Days

Shockwave Medical, a Johnson & Johnson MedTech unit, unveiled a next‑generation coronary intravascular lithotripsy (IVL) catheter that operates at 2 Hz, delivering ten pulses in five seconds—twice the speed of its current 1 Hz system. Early data from the multicenter Disrupt CAD...

By Cardiovascular Business
Nearly Half of All Surgeons Have Considered Leaving the Profession Due to Burnout
NewsMar 10, 2026

Nearly Half of All Surgeons Have Considered Leaving the Profession Due to Burnout

A Johnson & Johnson MedTech survey of 1,500 surgeons across five countries reveals that 43% have considered leaving surgery, rising to 65% among those experiencing burnout. Only 36% report positive mental health, while family‑time strain (48%), administrative burdens (47%) and long hours (44%)...

By Cardiovascular Business
Medtronic to Acquire Medtech Company Scientia Vascular for $550M
NewsMar 10, 2026

Medtronic to Acquire Medtech Company Scientia Vascular for $550M

Medtronic announced a $550 million acquisition of Salt Lake City‑based Scientia Vascular, a developer of FDA‑cleared guidewires and catheters for complex cerebral procedures. The transaction includes potential milestone payments that could raise the total consideration. Scientia, with over 300 employees, will...

By Cardiovascular Business
Next-Generation Guide Extension Catheter Delivers Value During Complex PCI
NewsMar 9, 2026

Next-Generation Guide Extension Catheter Delivers Value During Complex PCI

A new guide extension catheter, CrossFAST, received FDA clearance in December 2024 and has shown improved efficiency and safety in complex percutaneous coronary interventions. Early clinical experience with four patients demonstrated rapid, deep coronary intubation without balloon‑assisted tracking, reducing dissection risk...

By Cardiovascular Business
AATS Wants to Improve Research in the Field of Cardiothoracic Surgery
NewsMar 9, 2026

AATS Wants to Improve Research in the Field of Cardiothoracic Surgery

The American Association for Thoracic Surgery (AATS) has forged a partnership with the NHLBI‑backed Cardiothoracic Surgical Trials Network (CTSN) to accelerate practice‑changing clinical trials. CTSN’s existing infrastructure, which has already enrolled about 20,000 patients, will be leveraged to support new,...

By Cardiovascular Business
Moderate Valve Oversizing During TAVR Boosts Survival—Too Much May Be Less Beneficial
NewsMar 9, 2026

Moderate Valve Oversizing During TAVR Boosts Survival—Too Much May Be Less Beneficial

A recent study of over 1,800 TAVR patients (2020‑2025) found that moderate valve oversizing of 10 %‑20 % independently reduced all‑cause mortality, while minimal (<10 %) and severe (≥20 %) oversizing showed no survival benefit. Procedural outcomes, including stroke and vascular complications, were similar...

By Cardiovascular Business
Cardiology Now Has More than 200 FDA-Cleared AI Algorithms
NewsMar 6, 2026

Cardiology Now Has More than 200 FDA-Cleared AI Algorithms

An updated FDA registry shows cardiology now hosts more than 200 cleared AI algorithms, including 140 directly listed under the specialty and an additional 63 imaging‑focused tools. The total number of FDA‑cleared clinical AI applications reached 1,451, with radiology still...

By Cardiovascular Business
FDA Clears AI-Enabled Cardiac MR Planning Technology From Philips
NewsMar 6, 2026

FDA Clears AI-Enabled Cardiac MR Planning Technology From Philips

Philips received FDA clearance for SmartHeart, an AI‑driven planning solution that automates cardiac magnetic resonance (CMR) exam setup in under 30 seconds. The system configures 14 standard views, reduces patient breath‑holds by up to 75%, and embeds motion‑correction (Cardiac MoCo)...

By Cardiovascular Business
High-Sensitivity Troponin Protocol Most Successful at Freestanding EDs
NewsMar 5, 2026

High-Sensitivity Troponin Protocol Most Successful at Freestanding EDs

A new RACE‑IT study of 32,609 chest‑pain patients shows that a high‑sensitivity troponin protocol enables far faster discharge in freestanding emergency departments than in hospital EDs. Using an accelerated one‑hour rule‑out pathway, 95 % of low‑risk patients left freestanding sites safely,...

By Cardiovascular Business
Cardiologists Develop New AI Screening Tool for Structural Heart Disease
NewsMar 5, 2026

Cardiologists Develop New AI Screening Tool for Structural Heart Disease

Columbia University cardiologists unveiled EchoNext, an AI algorithm that analyzes standard electrocardiograms to screen for structural heart disease such as severe aortic stenosis, mitral regurgitation and heart failure. In a published JACC case report, the tool flagged an asymptomatic 84‑year‑old...

By Cardiovascular Business
AI Spots Heart and Lung Conditions in Eye Images of Premature Infants
NewsMar 5, 2026

AI Spots Heart and Lung Conditions in Eye Images of Premature Infants

Researchers have developed a deep‑learning algorithm that reads retinal photographs taken during routine retinopathy of prematurity (ROP) screenings to flag serious lung and heart conditions in preterm infants. In a study of 493 infants across seven NICUs, the model achieved...

By Cardiovascular Business
New AI-Enabled Heart Failure Implant Shows Early Potential
NewsMar 4, 2026

New AI-Enabled Heart Failure Implant Shows Early Potential

Relief Cardiovascular unveiled its AI‑enabled Relief System, an implantable valve and sensor that modulates inferior vena cava pressure to boost renal perfusion in diuretic‑resistant heart‑failure patients. In the first‑in‑human RELIEF‑FIH study of eight European participants, the device achieved 100% procedural...

By Cardiovascular Business
Cardiologists Perform First TAVR of Its Kind by Anchoring Valve to Crushed Stent
NewsMar 3, 2026

Cardiologists Perform First TAVR of Its Kind by Anchoring Valve to Crushed Stent

Interventional cardiologists performed the first ATLAS transcatheter aortic valve replacement, anchoring a Sapien 3 valve to a crushed Palmaz stent in a 75‑year‑old woman with severe non‑calcified aortic regurgitation and prior aortic dissection. The heart team selected the non‑coronary cusp for...

By Cardiovascular Business
Johnson & Johnson Launches 3 New Stroke Devices
NewsMar 2, 2026

Johnson & Johnson Launches 3 New Stroke Devices

Johnson & Johnson MedTech launched three new stroke devices—Cereglide 42 and Cereglide 57 aspiration catheters and the Innerglide 7 delivery aid—expanding its aspiration‑first portfolio. The catheters feature a multi‑axial shaft, radiopaque tips and hydrophilic coating to improve navigation of distal clots. Innerglide 7 provides...

By Cardiovascular Business
FDA Approves Next-Generation CardioMEMS Reader for Heart Failure Monitoring
NewsFeb 27, 2026

FDA Approves Next-Generation CardioMEMS Reader for Heart Failure Monitoring

Abbott received FDA approval for its next‑generation CardioMEMS HERO reader, a pulmonary artery pressure device for heart‑failure patients. The HERO unit is 60% lighter than earlier readers and incorporates built‑in Wi‑Fi and cellular connectivity, allowing measurements anywhere. The upgrade builds on...

By Cardiovascular Business
AI Helps Identify Risk in Adults with Congenital Heart Disease
NewsFeb 27, 2026

AI Helps Identify Risk in Adults with Congenital Heart Disease

Survival rates for congenital heart disease (CHD) have risen, creating an estimated 1.4 million adult patients who often require repeat surgeries. At the 2026 Society of Thoracic Surgeons meeting, Mayo Clinic researchers presented a machine‑learning model that isolates 15 key variables...

By Cardiovascular Business
New Heart Device for ‘No-Option’ Chest Pain Patients Shows Early Potential
NewsFeb 27, 2026

New Heart Device for ‘No-Option’ Chest Pain Patients Shows Early Potential

VahatiCor’s A‑Flux Reducer System, a self‑expanding, recapturable coronary sinus device, was implanted in a first‑in‑human cohort of 12 patients with coronary microvascular dysfunction or obstructive CAD. Eleven procedures were completed without any device‑related complications, and patients experienced significant improvements in...

By Cardiovascular Business
Whole-Body MRI Provider Starts Offering AI-Powered CCTA Scans
NewsFeb 26, 2026

Whole-Body MRI Provider Starts Offering AI-Powered CCTA Scans

TrueScan, a whole‑body MRI center in St. Peterburg, Florida, has begun offering AI‑powered coronary CT angiography (CCTA) from Heartflow, available as a standalone test or bundled with its MRI packages. The move addresses growing patient and physician demand for coronary imaging...

By Cardiovascular Business
3D Software Helps Cardiologists Plan Ahead for TAVR Complications
NewsFeb 26, 2026

3D Software Helps Cardiologists Plan Ahead for TAVR Complications

Sentara’s high‑volume TAVR center adopted the AI‑enabled DASI 3‑D planning platform to move beyond static CT measurements. The software dynamically simulates valve frame expansion, calcium deformation, and tissue interaction, allowing clinicians to test multiple valve sizes and depths before the...

By Cardiovascular Business
PFO Closure After Thromboembolism Linked to Strong 20-Year Outcomes
NewsFeb 25, 2026

PFO Closure After Thromboembolism Linked to Strong 20-Year Outcomes

A new 20‑year follow‑up of 130 patients who received transcatheter patent foramen ovale (PFO) closure after a paradoxical embolism shows sustained safety and efficacy. The cohort, with a mean age of 46, experienced a recurrent stroke rate of 0.04 per...

By Cardiovascular Business
FDA Shares New Warning About Johnson & Johnson Heart Pumps After 4 Injuries
NewsFeb 25, 2026

FDA Shares New Warning About Johnson & Johnson Heart Pumps After 4 Injuries

The FDA issued an early‑alert notice on February 3, 2026, highlighting a leak risk in Generation 1 purge cassettes used with Johnson & Johnson MedTech’s Impella RP heart‑pump sets. A leak can trigger a low‑pressure alarm, potentially causing biomaterial ingress, pump stoppage, and loss...

By Cardiovascular Business
ASE Promoting 3D Echo as a Better Way to Treat Congenital Heart Disease
NewsFeb 23, 2026

ASE Promoting 3D Echo as a Better Way to Treat Congenital Heart Disease

The American Society of Echocardiography (ASE) is championing 3‑dimensional echocardiography as the preferred tool for diagnosing and guiding treatment of congenital heart disease. ASE is standardizing image display and terminology to align imagers, interventional cardiologists, and surgeons, and will deliver...

By Cardiovascular Business
FDA Approves New Biotronik Pacing Lead for LBBAP
NewsFeb 23, 2026

FDA Approves New Biotronik Pacing Lead for LBBAP

Biotronik received FDA clearance for its Solia CSP S pacing lead, a device engineered specifically for left bundle branch area pacing (LBBAP). The lead combines a stylet‑driven platform with a novel fixed‑helix screw, addressing procedural simplicity and electrical performance. Approval relied on...

By Cardiovascular Business
Heart Failure Company BioVentrix Files for IPO
NewsFeb 19, 2026

Heart Failure Company BioVentrix Files for IPO

BioVentrix, a Massachusetts medtech firm developing the Revivent heart‑failure system, filed an IPO prospectus on Feb. 12, targeting a Nasdaq listing under BVXX. The company estimates a $10 billion valuation in the U.S. and $16 billion globally. Revivent, a minimally invasive LV reconstruction...

By Cardiovascular Business
Gore Completes Acquisition of Medtech Company Behind Next-Gen Heart Device
NewsFeb 19, 2026

Gore Completes Acquisition of Medtech Company Behind Next-Gen Heart Device

W. L. Gore & Associates has completed its acquisition of Conformal Medical, the developer of the investigational CLAAS AcuFORM left atrial appendage occlusion system. The deal, announced in January, makes Conformal a wholly‑owned Gore subsidiary while keeping its focus on the foam‑based...

By Cardiovascular Business
Medtronic’s RDN System Receives New Reimbursement Approval
NewsFeb 19, 2026

Medtronic’s RDN System Receives New Reimbursement Approval

Medtronic’s Symplicity Spyral renal denervation system has secured reimbursement approval from Japan’s Ministry of Health, Labour and Welfare, expanding coverage for resistant hypertension. The therapy, which uses radio‑frequency energy to ablate renal nerves via a single catheter, was previously approved...

By Cardiovascular Business
AI-Powered MRI Evaluations Predict STEMI Outcomes Better than Existing Risk Scores
NewsFeb 17, 2026

AI-Powered MRI Evaluations Predict STEMI Outcomes Better than Existing Risk Scores

A machine‑learning model that combines cardiac MRI data with clinical variables predicts long‑term major adverse cardiovascular events (MACE) in STEMI patients more accurately than the GRACE and TIMI scores. The study analyzed 1,066 patients, training on 682 cases and testing...

By Cardiovascular Business
TAVR Linked to Higher Reintervention Rate than SAVR in Evolut Low Risk Trial Update
NewsFeb 17, 2026

TAVR Linked to Higher Reintervention Rate than SAVR in Evolut Low Risk Trial Update

A six‑year update of the Medtronic‑funded Evolut Low Risk trial shows that transcatheter aortic valve replacement (TAVR) with a self‑expanding valve has a higher reintervention rate than surgical aortic valve replacement (SAVR) in low‑risk patients—5.5% versus 3.3% at six years,...

By Cardiovascular Business
FDA Clears 12-Lead, Cable-Free Home ECG Monitoring System
NewsFeb 17, 2026

FDA Clears 12-Lead, Cable-Free Home ECG Monitoring System

The FDA granted 510(k) clearance for HeartBeam’s cable‑free 12‑lead ECG synthesis software, allowing home‑based arrhythmia assessment. The system captures cardiac signals in three non‑coplanar dimensions and reconstructs a full 12‑lead trace that can be reviewed by board‑certified cardiologists on demand....

By Cardiovascular Business
CVRx Highlights Revenue Growth in Q4, Increased Momentum Going Forward
NewsFeb 13, 2026

CVRx Highlights Revenue Growth in Q4, Increased Momentum Going Forward

CVRx reported fourth‑quarter 2025 revenue of $16 million, a 4% year‑over‑year increase. Full‑year revenue rose 10% to $56.7 million, and the network of active implanting centers expanded to 252. The company secured Category 1 CPT codes for its Barostim device effective Jan 1 2026 and...

By Cardiovascular Business
CCTA Becoming an Essential Tool for Interventional Cardiologists
NewsFeb 13, 2026

CCTA Becoming an Essential Tool for Interventional Cardiologists

Coronary computed tomography angiography (CCTA) is becoming a core tool for interventional cardiologists, enabling comprehensive pre‑procedure planning and reducing reliance on costly intravascular imaging. The addition of fractional flow reserve derived from CT (FFR‑CT) merges anatomical and physiological assessment, streamlining...

By Cardiovascular Business