This cardiovascular update spotlights key developments, regulatory milestones, and the latest progress shaping the biopharma landscape.
In Today’s Newsletter
Dive deeper
🫀 Ultromics gets AHA Go Red investment for EchoGo HFpEF AI [1] [UK • 19 Dec 2025]
Context: FDA-cleared EchoGo Heart Failure analyzes standard echos for HFpEF, trained on outcomes data.
Key point: American Heart Association’s Go Red for Women Venture Fund invests, amount undisclosed.
Implication: Partnerships/BD. Signals pipeline investment and modality expansion.
👶 Abbott Piccolo new delivery system cleared in US and CE marked [2] [US/EU • 18 Dec 2025]
Context: Single-catheter, shorter, softer delivery for Amplatzer Piccolo PDA occluder in tiny preemies.
Key point: FDA clearance and CE mark for updated delivery system to simplify PDA closure.
Implication: Regulatory/generics. Introduces competition that may affect pricing and formulary access.
📲 Vivio non-invasive LV-EDP screening shows accuracy vs echo and BNP [3] [22 Dec 2025]
Context: FDA validation study, 728 patients, multicentre; JAHA publication.
Key point: Vivio achieved 80% sensitivity and 83% specificity for elevated LV-EDP, outperforming echo and BNP (study-specific).
Implication: Observational/RWE. Could inform practice and payer discussions; interpretation depends on study design and confounding control.
💉 Sapien M3 TMVR earns first US approval for transseptal MR replacement [4] [US • 23 Dec 2025]
https://cardiovascularnews.com/transseptal-tmvr-system-gains-us-fda-approval/
Context: Indicated for symptomatic moderate-to-severe MR in non-surgical or non-TEER candidates; ENCIRCLE pivotal met endpoints.
Key point: First transseptal TMVR approved in US, with strong 1-year MR reduction and QoL gains (per study).
Implication: Clinical topline/efficacy. May influence prescriber choice and payer reviews pending full data.
🧪 Myqorzo (aficamten) approved for oHCM, flexible REMS vs Camzyos [5] [US • 22 Dec 2025]
Context: Approval supported by MAPLE-HCM exercise capacity data; REMS allows earlier titration and fewer constraints.
Key point: FDA approval positions Cytokinetics to challenge BMS in oHCM, pricing to align with category.
Implication: Clinical topline/efficacy. May influence prescriber choice and payer reviews pending full data.
🤝 Gore to acquire Conformal Medical, adding CLAAS AcuFORM LAAO [6] [05 Jan 2026]
https://cardiovascularnews.com/gore-enters-into-agreement-for-acquisition-of-conformal-medical/
Context: CLAAS uses nitinol endoskeleton with foam matrix; aims for fewer sizes and potential same-day LAAO.
Key point: Definitive agreement signed, closing expected early 2026 pending approvals.
Implication: Partnerships/BD. Signals pipeline investment and modality expansion.
🪨 Sonico-CX coronary IVL wins EU MDR CE mark [7] [EU • 06 Jan 2026]
https://cardiovascularnews.com/sonico-cx-coronary-ivl-system-gains-ce-mark/
Context: 360-degree energy, up to 120 pulses, 7 balloon sizes, low crossing profile; Europe/Middle East launch planned.
Key point: CE mark enables European commercialization, with pipeline including forward-firing IVL.
Implication: Regulatory/generics. Introduces competition that may affect pricing and formulary access.
🤖 SSi Mantra adds 5 mm robotic instruments for small-structure surgery [8] [06 Jan 2026]
Context: New 5 mm tools include cauteries, drivers, and forceps; use cases in CABG and head-neck.
Key point: SS Innovations expands instrument suite to support delicate anatomy and telesurgery footprint.
Implication: Partnerships/BD. Signals pipeline investment and modality expansion.
🧠 Cleveland Clinic Akron General earns Comprehensive Stroke Center status [9] [US • 06 Jan 2026]
Context: Joint Commission CSC designation, 24/7 EVT, neuro-ICU, advanced imaging, new endovascular suite.
Key point: Program joins top-tier stroke centers, treating 1,000+ stroke patients annually.
Implication: Access programs. May expand screening, initiation, and follow-up at scale.
🫧 Acesion starts Phase 2 AP31969 in atrial fibrillation [10][13] [EU • 06 Jan 2026]
https://manufacturingchemist.com/acesion-pharma-begins-phase-ii-cardiac-arrythmia-trial
Context: Randomised, double-blind, placebo-controlled, 200 patients across eight EU countries; primary AF burden; loop recorders.
Key point: First-in-class SK ion-channel inhibitor advances with design focused on efficacy and ventricular proarrhythmia safety.
Implication: Clinical topline/efficacy. May influence prescriber choice and payer reviews pending full data.
🧲 Stereotaxis Magic catheter gets US FDA approval for robotic EP ablation [11] [US • 06 Jan 2026]
https://cardiacrhythmnews.com/stereotaxis-secures-us-fda-approval-for-magic-ablation-catheter/
Context: Magnetic navigation for mapping and ablation, aimed at complex arrhythmias and congenital anatomy constraints.
Key point: Approval underpins continued adoption of robotic EP with precision and stability advantages.
Implication: Clinical topline/efficacy. May influence prescriber choice and payer reviews pending full data.
🧷 Upstate performs first MitraClip TEER, builds valve program [12] [US • 06 Jan 2026]
https://www.upstate.edu/news/articles/2026/2026-01-06-mitraclip1.php
Context: 92-year-old, severe MR reduced after TEER; plan for 50+ annual cases and broader tricuspid/mitral offerings.
Key point: Hospital initiates transcatheter valve program to expand options for high-risk patients.
Implication: Access programs. May expand screening, initiation, and follow-up at scale.
🧠⚡ Ceribell AI-EEG earns Breakthrough Device for in-hospital LVO detection [14] [US • 06 Jan 2026]
Context: Uses existing Ceribell hardware with AI to interpret EEG for early LVO stroke detection; prospective multicentre validation cited.
Key point: Breakthrough designation recognizes potential for faster detection in non-neuro units.
Implication: Observational/RWE. Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧫 Reference map exposes immaturity in lab-grown heart cells [15]
https://www.eurekalert.org/news-releases/1111631
Context: GIMM team compares in-vitro cardiomyocytes to human developmental trajectory in Stem Cell Reports.
Key point: Lab-grown cells remain developmentally immature; new benchmark map aims to improve model quality.
Implication: Observational/RWE. Could inform practice and payer discussions; interpretation depends on study design and confounding control.
Why it matters
- Transcatheter valve and structural heart options are expanding in MR and LAAO, potentially reaching previously untreatable patients [4][6][12].
- Robotic and magnetic EP platforms may broaden access to precise ablation in complex anatomies [11].
- AI at point of care is pushing earlier detection in HF and stroke, with regulatory momentum [3][14].
- Coronary calcium modification continues to diversify with new IVL entrants under EU MDR [7].
- AF pipeline innovation targets efficacy with improved ventricular safety profiles via SK channel inhibition [10][13].
🚀 Accelerate your success. Contact us now
📂 Explore our case studies. See examples of our work.
💡 Read our insights. Learn from our latest reports and analysis
🎬 Watch on YouTube. Subscribe and never miss a video.
🧰 See our full range of services. Discover how we can help you.
📚 See the full Cardiovascular archive on our research hub page
FAQ
What makes Sapien M3 distinct among mitral options?
Sapien M3 is the first US-approved transseptal TMVR for symptomatic moderate-to-severe MR in patients unsuitable for surgery or TEER, with pivotal data showing MR reduction and QoL gains at 1 year [4].
How does Myqorzo’s REMS differ from Camzyos?
Per analyst commentary, Myqorzo allows earlier titration and flexible echo timing, aiming to reduce logistical burden vs Camzyos’ more rigid algorithm. Maintenance echos remain required every six months [5].
What is unique about the Stereotaxis Magic catheter approval?
Magic is a robotically navigated magnetic ablation catheter for complex EP, offering precise, stable navigation where manual access is constrained, now FDA approved in the US [11].
What does Ceribell’s Breakthrough designation cover?
It covers an AI-based EEG algorithm to detect in-hospital LVO stroke using existing Ceribell hardware, aiming for earlier detection in non-neuro units. Clearance is pending [14].
How is Acesion’s Phase 2 AF study designed?
A randomised, double-blind, placebo-controlled trial in 200 patients across eight EU countries, measuring AF burden via implantable loop recorders and monitoring ventricular proarrhythmia as a key safety endpoint [10][13].
What is Gore acquiring with Conformal Medical?
Gore signed a definitive agreement to acquire Conformal’s CLAAS AcuFORM LAAO platform, which uses a foam-matrix implant intended to simplify sizing and enable potential same-day procedures. Closing is expected early 2026 pending approvals [6].
Entities / Keywords
Edwards Lifesciences; Sapien M3 TMVR; mitral regurgitation; TEER; Cytokinetics; Myqorzo; aficamten; BMS Camzyos; Stereotaxis; Magic catheter; robotic magnetic navigation; Ceribell; EEG; LVO stroke; Abbott; Amplatzer Piccolo; PDA; Spectrumedics; Sonico-CX IVL; Acesion Pharma; AP31969; SK ion-channel inhibitor; Gore; Conformal Medical; CLAAS AcuFORM LAAO; Ultromics; EchoGo Heart Failure; Ventric Health; Vivio; GIMM; stem-cell cardiomyocytes.
References
- https://femtechinsider.com/ultromics-receives-investment-from-american-heart-associations-go-red-for-women-venture-fund/
- https://cardiovascularnews.com/delivery-system-for-pda-closure-in-premature-infants-gains-regulatory-approvals/
- https://cardiovascularnews.com/non-invasive-screening-system-actively-detects-elevated-lv-end-diastolic-pressure/
- https://cardiovascularnews.com/transseptal-tmvr-system-gains-us-fda-approval/
- https://healtheconomics.com/cytokinetics-receives-fda-approval-for-myqorzo-to-compete-in-heart-disease-market/
- https://cardiovascularnews.com/gore-enters-into-agreement-for-acquisition-of-conformal-medical/
- https://cardiovascularnews.com/sonico-cx-coronary-ivl-system-gains-ce-mark/
- https://cardiovascularnews.com/robotic-surgical-system-adds-5mm-instruments-for-use-in-small-structures/
- https://newsroom.clevelandclinic.org/2026/01/06/cleveland-clinic-akron-general-receives-highest-level-of-stroke-care-designation
- https://manufacturingchemist.com/acesion-pharma-begins-phase-ii-cardiac-arrythmia-trial
- https://cardiacrhythmnews.com/stereotaxis-secures-us-fda-approval-for-magic-ablation-catheter/
- https://www.upstate.edu/news/articles/2026/2026-01-06-mitraclip1.php
- https://pharmatimes.com/news/acesion-pharma-launches-phase-2-trial-of-ap31969-in-atrial-fibrillation/
- https://neuronewsinternational.com/ceribell-receives-us-fda-breakthrough-device-designation-for-in-hospital-lvo-stroke-detection-monitor/
- https://www.eurekalert.org/news-releases/1111631