Roy Jakobs, CEO at Royal Philips.

Welcome to the last issue of Cardiac Wire for the year since we’ll be taking a break for the holidays. Thank you to all our readers and sponsors who make this newsletter possible, and keep an eye out for our next issue on January 5th.

With the recent CMS reimbursement announcement for CT-based plaque analysis, it’s never been more important to understand the value it provides. Watch the latest episode of the Cardiac Wire Show to hear from Circle Cardiovascular Imaging’s CMO, Kevin Steel, DO about their new plaque analysis software and how it changes your CAD workflow.

Cardiology Business

Philips Acquires SpectraWAVE, Making Azurion Even Better

After taking a two and a half year break since its last acquisition, Philips acquired SpectraWAVE for its HyperVue and X1-FFR technologies in a bid to extend its intravascular imaging lead.

• SpectraWAVE focuses on vascular imaging that combines DeepOCT (optical coherence tomography) and NIRS (near-infrared spectroscopy) with AI and angio-based FFR.
• These technologies are designed to improve percutaneous coronary intervention, with X1-FFR and HyperVue now coming to Philips’ Azurion platform.
• Although financials haven’t been disclosed, SpectraWAVE has raised at least $79M across its venture, Series A, and Series B rounds.

At the center of this acquisition, Philips’ Azurion is an image-guided therapy platform that already serves 7.6M patients annually. It combines coronary imaging and physiology with Philips’ Eagle Eye Platinum IVUS and OmniWire iFR offerings, but the addition of SpectraWAVE’s tech takes it to the next level…

• With SpectraWAVE’s HyperVue, Philips will now have a single enhanced vascular imaging platform that provides detailed coronary artery visualization.
• On the other hand, X1-FFR calculates fractional flow reserve from angiograms, allowing Philips to turn X-ray images into physiology data without wire-based measurements.

These technologies add to Philips’ impressive intravascular imaging toolbox which now boasts IVUS, DeepOCT, NIRS, wire and angio-derived physiology all accessible to imagers on the Azurion platform.

While it might have been a minute since Philips’ last big buy, bringing in SpectraWAVE is part of a decade long mission to built-out its cardiology offerings with acquisitions like –

• Volcano (2015, IVUS and FFR)
• TomTec (2017, echo PACS)
• BioTelemetry (2020, remote cardiac diagnostics & monitoring)
• Intact Vascular (2020, peripheral vascular devices)
• Vesper Medical (2021, peripheral vascular devices)
• Cardiologs (2021, ECG AI)
• And DiA Imaging Analysis (2023, echocardiography AI)

All of these individual technologies were effective, that’s why Philips bought them, but this trend is bigger than just buying the best parts for a custom car, it represents a maturation of Philips’ position across several subspecialties of cardiology.

• With all of these technologies on one platform, physicians who use Azurion will now have a single decision loop in their vascular imaging workflow.
• Meanwhile, the AI integration side of Azurion puts all of the data in one place, reducing the strain on physicians managing several softwares across modalities to get a diagnosis.

The Takeaway

Philips’ acquisition of SpectraWAVE is about more than being better than the competition. It represents a focus on being the best for Azurion’s users and it isn’t a surprise when you look back at how Philips built the platform.

GLS Analysis of Us2.ai’s Fully-Automated Software

Ten years after the first head-to-head comparison of 2D echocardiography, the latest review suggests Us2.ai is among the easiest to use and integrate. Read the study to learn about how Us2.ai’s software requires zero operator input, operates without human intervention, and leads to high agreement with traditional semi-automated speckle- tracking software solutions.

CMR Access Is Broken — Here’s How to Fix It

Cardiac MRI is one of the most powerful tools for diagnosing heart disease, yet it’s still out of reach for many patients. Download Vista AI’s new infographic to see what’s holding CMR adoption back—and how AI and automation can help make gold-standard imaging more accessible than ever.

Cracking the Code of ECG Analysis with Monebo’s AI Genetic Algorithm

How do you teach a computer to recognize the complex patterns in an ECG signal? Discover how Monebo found the answer by blending human expertise and a little evolutionary magic in this article that breaks down the advantages of genetic algorithms in ECG analysis.

The Wire

• Aficamten Earns CHMP Nod: Inching ever closer to its Dec. 26th PDUFA date, Cytokinetics announced that Europe’s drug regulator (CHMP) has recommended approval of MYQORZO (aficamten) for treating obstructive hypertrophic cardiomyopathy in adults. The recommendation follows positive results from the SEQUOIA-HCM trial, which showed the drug significantly improved exercise capacity and was well-tolerated. A final European Commission decision is expected in early 2026.

• Milestone’s FDA Milestone. The FDA approved Milestone Pharmaceuticals’ CARDAMYST (etripamil), making it the first new treatment for paroxysmal supraventricular tachycardia (PSVT) in over 30 years. The nasal spray allows adults to self-administer medication during PSVT episodes, avoiding emergency room visits. The FDA approval stems from clinical trials that showed patients were twice as likely to restore normal heart rhythm within 30 minutes compared to placebo. CARDAMYST will be available in early 2026, benefiting over two million Americans with PSVT.

• Alnylam Expands siRNA Production: Alnylam Pharmaceuticals announced a $250M expansion of its Norton, Massachusetts facility to build the pharma industry’s first ever siRNA enzymatic-ligation manufacturing plant. The company’s siRELIS platform for siRNA manufacturing will significantly increase production capacity and reduce costs, while supporting the company’s growing cardiovascular drug pipeline. The FDA has already accepted the platform into its Emerging Technology Program, accelerating regulatory discussions, and construction is underway, with full operations expected by late 2027.

• MRI of Cardiac Fat Predicts Risk: Supporting the value of imaging-based biomarkers, a recent study found that cardiac MRI measurements of fat around the heart predicted cardiac injury after heart attack. Researchers at EACVI 2025 presented data on 1.2k patients who got cardiac MRI scans within 10 days after a PCI following a heart attack and found that higher epicardial fat volume was associated with greater infarct size and larger area at risk, but lower microvascular obstruction.

• Plaque Burden Matters: Cleerly presented research at CVCT from the CONFIRM2 Registry showing that its AI-based plaque analysis can identify high-risk patients with non-obstructive coronary artery disease. The 6.5k patient study found that those with non-obstructive disease but high plaque burden (over 750mm³) had major cardiac event rates comparable to or exceeding patients with severe blockages. The findings suggest total plaque burden throughout the heart drives risk independent of blockage severity, which could change cardiac risk assessment approaches.

• LIB’s PCSK9i Earns FDA Approval: Adding another contender to the PCSK9i race, LIB Therapeutics received FDA approval for its drug, LEROCHOL, (lerodalcibep-liga), a third-generation PCSK9 inhibitor for lowering LDL-C in adults with hypercholesterolemia, including familial hypercholesterolemia. LEROCHOL is taken as a once-monthly self-administered injection, and has shown consistent LDL-C reductions of 50-60% in clinical trials. LIB believes that LEROCHOL’s three month room-temperature stability, helps differentiate it from other approved PCSK9is. The drug is expected to be available in spring 2026.

• PFA or RFA? Why Not Both? AtriCure unveiled results from its successful first-in-human treatments using its dual energy ablation platform that combines Pulsed Field Ablation and Advanced Radiofrequency Ablation with its EnCompass clamp. Per the study, the technology reduced procedural ablation time to under 60 seconds in initial patients, compared to traditional approaches. The platform also successfully merged radiofrequency ablation’s proven safety with PFA’s efficiency for treating atrial fibrillation during cardiac surgery. The technology is not yet approved and AtriCure plans to initiate clinical trials within the coming year.

• SERF’s Up (For Ablation): In another ablation first, Thermedical announced it successfully treated its first patient in a pivotal clinical trial evaluating its Saline Enhanced Radiofrequency (SERF) Ablation System for severe ventricular tachycardia. The patient, who had failed four previous ablation procedures, had all of his/her abnormal heart rhythms successfully eliminated during the procedure. Thermedical believes that SERF ablation enables deeper tissue penetration than regular methods, targeting difficult-to-reach heart circuits that cause dangerous arrhythmias.

• ANOCA’s Real Severity: According to a Danish registry analysis, angina but no obstructive coronary artery disease (ANOCA) might not be so worrisome after all. Researchers followed over 21k patients with ANOCA and found that their 15-year outcomes were pretty similar to the general population. ANOCA patients had similar heart attack rates, slightly higher stroke risk, and slightly lower mortality compared to age- and sex-matched controls.

• Auxira Lands its Early Funds: Auxira Health raised $7.8M in seed funding to expand its virtual cardiology care model that aims to address capacity shortages nationwide. As part of its care platform, Auxira virtually embeds clinical teams consisting of advanced practice providers, medical assistants, and nurses into existing cardiology practices after in-person training. Early study results suggest this model leads to shorter wait times, improved patient satisfaction, and reduced physician workload. The company expects to support over 100 cardiologists by mid-2026.

• Ultromics’ Echo AI Earns AHA Backing: Ultromics secured financial support from the AHA’s Go Red for Women Venture Fund to help expand access to its AI platform for detecting heart failure with preserved ejection fraction (HFpEF). HFpEF disproportionately affects women and Ultromics’ FDA-cleared EchoGo Heart Failure software could help close the gap by analyzing routine cardiac ultrasounds to identify early disease signs. Although the exact number of AHA funds isn’t available, Ultromics already raised $55M in Series C funds this year (bringing its total to $112.7M before this announcement).

Circle CVI’s CAD-RADS Rundown

Ever wondered how CAD-RADS enhances the communication of coronary artery disease findings from imaging studies? Check out this guide from Circle Cardiovascular Imaging about the evolution of CAD-RADS and how to incorporate it into your practice.

Identify and Treat Cardiovascular Disease

Complex care pathways make getting patients to the next step a challenge. See how Tempus Next, an AI enabled care pathway platform, helps providers identify and reduce under treatment in cardiovascular disease by adding an intelligent layer onto their routinely generated EHR data.

Changes in Heart Failure Management

Heart failure is a complex condition with high heart failure hospitalization and cardiovascular mortality rates, especially among patients with HFpEF and HFmrEF, for whom treatment options have been limited. Read how Bayer’s Dr. Alanna Morris-Simon discusses the changing treatment landscape and strategies for improving patient outcomes.

The Resource Wire

• Explore Vitrea Advanced Visualization: Discover Canon Medical Healthcare IT’s suite of advanced imaging workflows designed to increase efficiency in cardiovascular imaging, and facilitate the assessment, diagnosis, and treatment of cardiovascular diseases. These cutting-edge tools support the delivery of faster, more accurate care while integrating seamlessly into clinical workflow.

• From CPACS to CVIS: Cardiovascular imaging has come a long way from CPACS. Explore the evolution of cardiology image and data management in this Merge executive brief, and see what makes CVIS such a significant advancement.

• Personalized Plaque Analysis Now With Medicare Coverage: Heartflow’s Plaque Analysis is now reimbursable thanks to Medicare’s new coverage for AI-enabled plaque analysis of eligible patients with coronary artery disease.

• 5,600 Ways to Improve Your Cardiac Ultrasound Workflow: AI-powered measurements can enhance the way you acquire and interpret cardiac ultrasound. Learn how AI-powered ultrasound can help you overcome everyday limitations in echo. Read Siemens Healthineers’ white paper on how its AI software provides 5,600+ automated measurements to help improve workflow efficiency, consistency, and clinical confidence.

• Relieving The Burden of Post-Processing: With the advent of advanced imaging technologies like CCTA come added burdens to technologists and diagnostic imaging centers. See how PIA can relieve the burden of post-processing, saving you time while helping your bottom line.

The Industry Wire

1. GOP defectors force vote on extending ACA subsidies.
2. Measles outbreaks worsen across the U.S. 
3. CDC adopts controversial change to hepatitis B vaccine policy.
4. FDA to accept de-identified real-world evidence for medical device submissions.
5. American brain drain? Why scientists are leaving the U.S.
6. Eli Lilly’s new weight-loss drug could be agonist triple-threat.
7. Optum and Humana duke it out over MA plan in Washington state.
8. New York state to invest $300M in health IT, cybersecurity. 
9. Health systems see potential of gen AI for revenue management.
10. Dana-Farber to pay $15M to settle charges of publishing fraud.