10 Cardiology Headlines You Missed in May 2026

May was a busy month for cardiology, with major decisions from the US Food and Drug Administration (FDA) competing with topline and final results from a plethora of major trials. Additionally, the publication of guidelines on everything from heart failure (HF) to postpartum care rounded out the month with new approaches to and methods of disease prevention.

With so much news released in the last month, the editorial team at HCPLive has collected 10 of the most impactful headlines to come out of cardiology in May of 2026. Catch up on any major news you may have missed below:

FDA News

FDA Grants De Novo Status to Cardiosense PCWP Software for HFrEF

On May 27, 2026, the FDA granted de novo classification to Cardiosense’s PCWP Analysis Software, a noninvasive, AI-enabled tool allowing clinicians to estimate pulmonary capillary wedge pressure (PCWP) in adults with HF with reduced ejection fraction (HFrEF), left ventricular ejection fraction ≤40%, and New York Heart Association (NYHA) functional class II, III, or IV symptoms.

FDA Grants Priority Review to Asundexian for Secondary Prevention After Ischemic Stroke

On May 19, 2026, the FDA granted priority review to Bayer’s investigational oral factor XIa inhibitor asundexian. The announcement was based on data from the OCEANIC-STROKE trial, a phase 3 study of the asundexian on top of standard antiplatelet therapy compared to placebo in patients with a recent non-cardioembolic ischemic stroke or transient ischemic attack.

FDA Approves Baxdrostat for Uncontrolled Hypertension on Background Therapy

On May 18, 2026, the FDA cleared AstraZeneca’s baxdrostat as an add-on for patients with hypertension not adequately controlled with other antihypertensive agents. The decision was based on the BaxHTN trial, which demonstrated baxdrostat’s efficacy in reducing seated systolic blood pressure compared to placebo. The oral aldosterone synthase inhibitor is now the first drug of its kind for hypertension.

Trial Results

PROACTIVE-HF: Cordella PA Sensor Improves HF Status Regardless of EF

The PROACTIVE-HF trial has associated the Cordella Pulmonary Artery (PA) sensor system with improved status in patients with HF irrespective of their ejection fraction (EF), according to 2-year data. Jason Guichard, MD, PhD, advanced HF and transplant cardiologist at Prisma Health and lead investigator on the study, spoke with HCPLive to address the substantially lower rates of hospitalization and mortality in patients equipped with this device.

ACACIA-HCM: Aficamten Beats Placebo in Non-Obstructive Hypertrophic Cardiomyopathy

Aficamten, a cardiac myosin inhibitor approved in December 2025 for symptomatic obstructive hypertrophic cardiomyopathy (oHCM), successfully outperformed placebo in the ACACIA-HCM trial. These data were announced on May 5, 2026, and highlighted improvements in both maximal exercise performance and KCCQ-CSS – in an interview with HCPLive, Ahmad Masri, MD, cardiomyopathy section head at Oregon Health & Science University, director of the OHSU hypertrophic cardiomyopathy center and OHSU Knight Cardiovascular Institute Cardiac Amyloidosis Program, and co-author of the study, discusses these topline data ahead of publication later this year.

RODEO-PTAB: PTAB Benefits Independent of Number of Runoff Vessels

RODEO-PTAB was a substudy of the DETOUR2 trial, which investigated the DETOUR System for percutaneous bypass of long segment femoropopliteal lesions. The analysis highlighted percutaneous transmural arterial bypass (PTAB) as an effective alternative to leg bypass surgery in patients with complex peripheral artery disease. In an interview with HCPLive, Sameh Sayfo, MD, program director of the Endovascular Intervention Fellowship at the Heart Hospital Baylor Plano and an interventional cardiology and peripheral endovascular specialist at Baylor Scott & White Health, discussed the superior safety of this process for patients suffering from this condition.

PROMISE III: Substantial Amputation-Free Survival With LimFlow TADV in CLTI

Patients with no-option chronic limb-threatening ischemia (CLTI) undergoing transcatheter arterialization of the deep veins (TADV) with the LimFlow system during the PROMISE III trial showed substantial rates of limb salvage and amputation-free survival. In an interview with HCPLive, Mehdi Shishehbor, DO, PhD, president of the Harrington Heart & Vascular Institute at University Hospitals, discusses the broader implications of this study for people with this debilitating condition.

Guideline Updates

Updated HFmrEF Guidelines From HFSA Support Standard HFrEF Treatment

A recent statement from the Heart Failure Society of America (HFSA) has encouraged the widespread recategorization of HF with moderately reduced ejection fraction (HFmrEF) as its own individual subcategory. In an effort to establish separate diagnosis, treatment, and management guidelines for this underrepresented population, the document highlights the current evidence to suggest the condition’s individuality from other HF subtypes and guides clinicians in determining alternative ways of addressing it in clinic.

New AHA Recommendations Encourage Improving Postpartum Cardiovascular Care

The AHA released a statement in May providing clinicians with tools and guidelines to prevent and treat cardiovascular disease in postpartum women. A historically understudied patient population, women who have recently given birth are actually at a substantially higher risk of heart disease, due to potential adverse pregnancy outcomes such as gestational diabetes or hypertensive disorders of pregnancy.

AHA Releases Updated Guidelines for Secondary Prevention Post-CABG

Despite being an effective therapy for coronary artery disease, coronary artery bypass grafting (CABG) is far from a permanent fix. These guidelines, updated for the first time since 2015, provide a series of recommendations to help clinicians manage their patients following the completion of this operation and prevent further disease progression.