Stuart Goldstein, MD, is the director of the Center for Acute Care Nephrology at Cincinnati Children’s Hospital Medical Center. 

Children with sepsis-associated acute kidney injury (SA-AKI) who need continuous renal replacement therapy (CRRT) had higher survival with the selective cytopheretic device for pediatrics (SCD-PED; Quelimmune) than severity-matched historical controls, investigators reported.

Stuart Goldstein, MD, presented the data at 

American Society of Nephrology (ASN) Kidney Week 2026

, the FDA-mandated post-approval surveillance registry for the device, and are an observational comparison against an external historical cohort. Investigators said the findings support considering SCD-PED as a safe adjunctive therapy for eligible critically ill children, while a peer-reviewed manuscript is still pending.

SCD-PED Tied to Higher Survival in Septic AKI, With Stuart Goldstein, MD

Treatment options for pediatric SA-AKI remain limited and largely supportive. In a multicenter prospective pediatric CRRT registry of 116 children with multiorgan dysfunction, 39% of whom had sepsis, ICU survival was 51.7%.

“The gap that this device and the registry attempted to address is the fact that mortality for children with AKI and sepsis requiring CRRT has been 50% for the past two and a half decades, despite many advancements in critical care,” said Goldstein, director of the Center for Acute Care Nephrology at Cincinnati Children’s Hospital Medical Center, in an interview with HCPLive.

How the Selective Cytopheretic Device Works in Pediatric Sepsis-Associated AKI

approved SCD-PED under a humanitarian device exemption (HDE)

 for patients who weigh at least 10 kg, are 22 years or younger, and have SA-AKI requiring CRRT.

 The device is integrated into the CRRT circuit. Activated neutrophils and monocytes bind to its membrane fibers, which lowers overall levels of inflammatory mediators.4 Goldstein explained that the cells are then released back into circulation in a less inflammatory state.

“As opposed to a single drug target, or a single cytokine target, or a single protein target, or a single component of the immune system, what the SCD does is really quiet the immune system,” Goldstein said. “These patients are still able to fight infection, but they’re immunomodulated so that the effects of sepsis that rev up the immune system to attack blood vessels and other organs is really mitigated.”

Approval rested on a pooled analysis of 22 children from 2 prospective multicenter studies, which reported 77% survival.2 As a condition of the HDE, the FDA required a post-approval registry to confirm safety and probable benefit in routine practice. An 

 treated after approval found no device-related adverse events.

SAVE Registry Design: SCD-PED vs Kids’ Inpatient Database Controls

The analysis included children aged 1 year or older who received more than 1 day of SCD-PED treatment in SAVE, plus 1 patient treated outside the registry. Investigators compared them with severity-matched patients aged 1 to 20 years from the 2019 and 2022 Kids’ Inpatient Database (KID) who had sepsis, CRRT, mechanical ventilation, and vasopressor use or shock.

Survival was assessed at 28, 60, and 90 days and to hospital discharge. Comparisons used Fisher exact tests, frequentist odds ratios, and Bayesian posterior estimates with uniform priors. Outcomes measured only in SAVE were Day 90 renal replacement therapy (RRT) status in patients not RRT-dependent at baseline, serious adverse events (SAEs), and new secondary bloodstream infections (BSIs) within 28 days of starting the device.

SCD-PED Survival and Dialysis Independence Outcomes

The final cohorts were 43 patients in SAVE and 101, 95, and 196 cases from KID 2019, KID 2022, and the combined KID cohort, respectively. Core severity markers were similar between groups, including sepsis, CRRT, AKI, mechanical ventilation, and vasopressor use or shock (all 

Survival was higher in SAVE than in KID across all comparison windows. In-hospital survival was 65.1% in SAVE compared with 44.6% in KID 2019 (

 = .029) and 46.9% in the combined KID cohort (

 = .043). The Bayesian probability of higher survival in SAVE exceeded 95% for both comparisons.

Other comparisons also favored SAVE, with a Bayesian probability of benefit above 95% at Days 60 and 90 vs KID 2019, for in-hospital survival vs KID 2022, and at Day 60 vs the combined KID cohort.

Among the 24 survivors who were not RRT-dependent at baseline, 83% were RRT-free at Day 90. There were no device-related SAEs. Secondary BSIs occurred in 12% of patients within 28 days of starting the device, and none were device-related.

The analysis was observational, small, and compared registry patients against an administrative database rather than concurrent controls. The investigators described the results as real-world comparative data.

Expanding SCD-PED Use Beyond the Humanitarian Device Exemption

Goldstein said he hopes growing registry experience will eventually support use beyond the HDE’s strict criteria. That could include children with sepsis who do not need CRRT, or other highly proinflammatory states.

“But in a clinical setting, we have to practice under the guidelines of the humanitarian device exemption,” he said.

Editor’s Note: Goldstein reports relevant disclosures with SeaStar Medical.

Kleinman NL, Zolezzi DA, Gillespie RS, et al. Improved outcomes in pediatric sepsis-associated (SA) AKI: comparison of the selective cytopheretic device for pediatrics (SCD-PED) surveillance registry (SAVE) with a historical cohort. Abstract presented at: ASN Kidney Week 2026; October 21-25, 2026; Denver, CO.

Goldstein SL, Krallman KA, Harris M, et al. Early post-approval experience of the selective cytopheretic device surveillance registry for pediatric AKI requiring kidney replacement therapy. 

. 2026;41(7):2205-2212. doi:10.1007/s00467-026-07181-1

US Food and Drug Administration. Summary of safety and probable benefit: QUELIMMUNE (selective cytopheretic device), HDE BH220740. Published February 2024. Accessed November 2, 2026. 

https://www.fda.gov/media/176749/download

US Food and Drug Administration. Safety and utilization review for the Pediatric Advisory Committee: selective cytopheretic device for pediatrics (SCD-PED), HDE BH220740. Pediatric Advisory Committee Meeting; November 2025. Accessed November 2, 2026. 

https://www.fda.gov/media/189568/download

Videos

Kidney Week 2026 registry data linked a selective cytopheretic device to higher survival in children with septic AKI requiring CRRT.

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Rami Kahwash, MD, is a professor of medicine, cardiology and the director of the Heart & Vascular Research Organization at the Ohio State University Wexner Medical Center.

A year after implantable cardiac contractility modulation (CCM) therapy, patients exhibited substantial improvements across multiple cardiac health indicators, according to a new post-approval study.

Cardiac Health Indicators Improve Following CCM Implantation in Heart Failure

Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026

 in Phoenix, Arizona, by Rami Kahwash, MD, professor of medicine, cardiology, and director of the Heart & Vascular Research Organization at the Ohio State University Wexner Medical Center.

“The study is single-arm; we cannot establish causality here because of the design,” Kahwash told 

 in an exclusive interview. “But what we did notice is the concordance of all of these clinical outcomes, with all of them improving or heading in the right direction.”

The study itself was a prospective, multi-center, non-randomized, single-arm open-label study of patients receiving Impulse Dynamics’ OPTIMIZER implant and CCM therapy to treat 

 symptoms and left ventricular ejection fraction (LVEF) 25-45%. Eligible patients were ≥18 years old and had New York Heart Association (NYHA) Class 3 HF symptoms, among other criteria. Patients with primary HF due to uncorrected mitral valve disease, myocardial infarction within 90 days before implant, and with prior heart transplant or ventricular assist device implantation, among other criteria, were excluded.

Kahwash and colleagues included 3 primary outcome measures, including the incidence of procedure- and device-related complications at 1 year, all-cause mortality at 3 years, and procedure-related complications at 30 days. The main secondary outcome was the change in cardiovascular hospitalization rates and HF hospitalization rates from 1 year before implantation to 2 years following the operation.

Enrollment was initiated in February of 2020 and completed in September of 2025 – in this time, 692 patients were enrolled in the study and completed 3-year long-term follow-up. By June 2026, 1-year snapshots had been taken for analysis, with 530 patients ultimately having paired baseline and 1-year data. Among these 530 patients, mean age was 67.3 +/- 10.9 years, mean LVEF was 37.7% +/- 8.2%, and 40.6% had atrial fibrillation (AF). Additionally, 94% of patients were using beta blockers, 56.6% were using ARNIs, 27% were using ACEs or ARBs, and 35.7% were using SGLT2 inhibitors.

Ultimately, Kahwash and colleagues noted a 34% reduction in HF hospitalization at 1 year post-implant, decreasing from 152 events pre-CCM to 91 after 1 year (-34% change; 

 = .039). 97% of patients also saw improved or stabilized NYHA class at 1 year, and 68% had improved NYHA class at 1 year. Quality of life was also assessed by Minnesota Living with Heart Failure Questionnaire (MLHFQ), highlighting a minimal clinically meaningful improvement of ≥5 points in 70% of patients. NT-proBNP was stable from baseline to 1 year, and Kahwash and colleagues found a predictive association between elevated NT-proBNP – specifically >1000 pg/mL – and long-term mortality.

The team ultimately determined that, despite the non-randomized study design and lack of a control group, the study still adequately reflected real-world clinical practice and reflected outcomes in the setting of contemporary guideline-directed medical therapy (GDMT). Additionally, Kahwash addressed the trajectory of the study moving forward, as this 1-year data is far from the end of this analysis.

“We’re excited that this trial is not going to stop at 1 year. We’re following these patients for 3 years, so we’re going to have long-term follow-ups coming in,” Kahwash said. “I think the goal for this analysis in the next few years is to show that all those signals have been in concordance with more of the objective data that we’re going to be analyzing on a yearly basis, such as echocardiographic data and long-term follow-up with NT-proBNP.”

Editors’ Note: Kahwash reports disclosures with Impulse Dynamics, Medtronic, Edwards Lifesciences, VivaLinq, and Boston Scientific.

Kahwash M, Aziz E, Boo L, et al. One-Year Real-World Clinical Outcomes Following Cardiac Contractility Modulation Therapy from the U.S. Post-Approval Study. Presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026, Phoenix, AZ. October 9-12, 2026.

Impulse Dynamics. Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy (PAS). ClinicalTrials.gov Identifier: NCT03970343. Updated November 20, 2025. Accessed November 2, 2026. 

https://clinicaltrials.gov/study/NCT03970343?term=NCT03970343&rank=1

Rami Kahwash discusses his presentation at HFSA 2026, which highlighted the real-world efficacy of cardiac contractility modulation therapy.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Heart Failure

The HCPLive heart failure page is a resource for medical news and expert insights on HF. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for heart disease, reduced and preserved ejection fraction, and more.

A 487-gene test may help predict which patients with atopic dermatitis respond best to JAK inhibitors.

DecisionDx-Melanoma identified low-risk patients with 99.6% 5-year recurrence-free survival without a sentinel lymph node biopsy.

Ameluz photodynamic therapy offers a nonsurgical option for superficial basal cell carcinoma.

Molecular testing is moving from prognosis into treatment selection, and nonsurgical options for common skin cancers keep growing, according to Aaron S. Farberg, MD, chief medical officer at Bare Dermatology in Dallas, Texas. Farberg is a double board-certified dermatologist and fellowship-trained Mohs surgeon.

In a new interview, Farberg discussed both trends with 

2026 Fall Clinical Dermatology Conference

 in Las Vegas, Nevada, where he presented on biomarker-driven testing in dermatology and on multidisciplinary care in high-risk cutaneous squamous cell carcinoma.

Can a Gene Expression Test Guide Atopic Dermatitis Therapy Selection?

How Can Gene Expression Profiling Guide Atopic Dermatitis Therapy?

For moderate-to-severe atopic dermatitis, Farberg highlighted the 487-gene AdvanceAD-Tx test, which assigns patients to a JAK inhibitor responder profile or a T helper 2 (Th2) molecular profile. Among patients with the JAK inhibitor responder profile, 45.5% of those treated with a JAK inhibitor reached Eczema Area and Severity Index 90 by 3 months, compared with 8.3% of those given Th2-targeted therapy (

 = .021).³ Farberg described the test as a way to match systemic therapy to each patient’s disease biology rather than relying on clinical features alone. He has submitted a paper on how the test is used in practice, including for topical treatment decisions.

In melanoma, new prospective data for the 31-gene DecisionDx-Melanoma test were presented at the 2026 European Academy of Dermatology and Venereology Congress. The study included 2,799 patients across 29 US centers. Patients with a predicted sentinel lymph node positivity risk below 5% had an observed positivity rate of 4.4%, compared with 22.8% for those above 10%.² Among 565 low-risk patients who were eligible for sentinel lymph node biopsy but didn’t have one, 5-year recurrence-free survival was 99.6%.²

What Does the Ameluz Approval Mean for Basal Cell Carcinoma Care?

 approved aminolevulinic acid hydrochloride 10% gel (Ameluz) with BF-RhodoLED photodynamic therapy for superficial basal cell carcinoma in adults. In the pivotal trial, 66% (95/145) of treated patients achieved a composite clinical and histological complete response at 12 weeks, compared with 5% (2/42) receiving placebo.¹ Farberg noted that many patients would rather avoid excision, and the approval gives them a nonsurgical alternative for the most common cancer worldwide.

Looking ahead, Farberg expects psoriasis, atopic dermatitis and hidradenitis suppurativa to stay at the center of dermatology, with a deep psoriasis pipeline still advancing. For early-career clinicians, he stressed honesty and doing each task well enough that there’s no lingering doubt about patient care.

Editor’s Note: This summary has been edited for grammar and clarity using artificial intelligence tools. Farberg has previously disclosed serving as an advisor for Galderma, Johnson & Johnson Consumer, Castle Biosciences, Novartis, Orthodermatologics, and Sun Pharmaceuticals.

Smith T. Ameluz treatment becomes first FDA-approved PDT for skin cancer. 

. Published September 14, 2026. Accessed November 2, 2026. 

https://www.hcplive.com/view/ameluz-treatment-becomes-first-fda-approved-pdt-skin-cancer

Castle Biosciences. Late-breaking EADV 2026 data support use of DecisionDx-Melanoma in SLNB decision-making and risk-aligned post surgical management. Published September 30, 2026. Accessed November 2, 2026.

Silverberg JI, Eichenfield LF, Armstrong AW, et al. The 487-gene expression profile test guides systemic therapy selection [full title to confirm]. 

. Published online February 16, 2026. doi:10.1016/j.jaad.2026.02.034.

Aaron Farberg, MD, discusses gene expression testing in atopic dermatitis and melanoma, Ameluz PDT for basal cell carcinoma, and the psoriasis pipeline.

Atopic Dermatitis

Atopic Dermatitis condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatitis research, treatment, and drug development.

Eingun James Song, MD, is the director of clinical research for Frontier Dermatology. 

Linda Stein Gold, MD, is a dermatologist at Henry Ford Health. 

This episode, titled ‘Choosing Between Oral and Injectable PsO Therapy,’ features panelists discussing how route of administration influences systemic treatment decisions in plaque psoriasis. Historically, patients who prioritized efficacy were often steered toward biologic therapy even when they initially preferred an oral medication. The panel explains that this conversation is changing as newer oral therapies demonstrate greater efficacy and provide clinicians with more competitive alternatives.

Choosing Between Oral and Injectable PsO Therapy

Faculty discuss why patient preference cannot be reduced to simply choosing a pill over a needle. Injection frequency, ease of administration, safety, travel, refrigeration, and comfort with self-injection all influence how patients perceive biologic therapy. Some patients may be comfortable with an injection given only a few times per year, while others strongly prefer the familiarity and flexibility of a daily oral medication.

The experts also describe how newer oral options may be especially reassuring for patients taking their first step into systemic therapy. An oral medication may feel less intimidating and offers the perceived flexibility of stopping therapy without the prolonged exposure associated with some injectable agents. At the same time, widespread use of injectable therapies in other areas of medicine may be making some patients more comfortable with injections.

In the next episode, ‘Understanding the Pathophysiology of PsO,’ panelists will review the pathophysiology of psoriasis and explain how PDE4, TYK2, and IL-23–targeted oral therapies act within key inflammatory pathways.

Route of administration is becoming a more balanced decision as newer oral therapies narrow historical differences in treatment efficacy.

Video Series

In ‘Overcoming Delays in Systemic Treatment Escalation for PsO,’ our panel explores why some patients with plaque psoriasis remain on topical therapy despite persistent disease burden and potential candidacy for systemic treatment. The discussion begins with data showing that patients with relatively low body surface area may still perceive their psoriasis as moderate and that many continue to cycle through multiple topical therapies without escalating treatment.

Overcoming Delays in Systemic Treatment Escalation for PsO

The faculty identify several reasons for delayed escalation, including clinician comfort with systemic therapy, longstanding reliance on topical treatment in dermatology, and concerns about safety with newer medications. Dr. Stein Gold describes how conversations can change when psoriasis is framed not simply as a skin condition but as a systemic inflammatory disease, particularly when patients have substantial disease burden or possible psoriatic arthritis.

The panel also stresses the importance of clinician confidence and education. As systemic therapies have become more targeted and extensively studied, the faculty argue that providers should understand both their benefits and risks well enough to discuss them clearly with patients. Modern psoriasis care increasingly requires determining when topical treatment is no longer sufficient and when a systemic approach is more appropriate.

Our next episode, ‘Choosing Between Oral and Injectable PsO Therapy,’ examines how route of administration influences treatment decisions and how newer oral therapies may provide additional choices for patients considering systemic treatment.

Recognizing psoriasis as a systemic disease may help clinicians move appropriate patients beyond repeated topical treatment.

Articles

Stay updated with the latest healthcare breakthroughs, including new TRANSCEND-T2D-2 data and FDA actions.

Hepatology

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This page also hosts content previously published by EndocrinologyNetwork. 


The HCPFive: Top News for Healthcare Providers from the Week of 10/25

Professor, Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University

Director, Sarcoidosis Program, Temple University Hospital

Rohit Gupta, MD, discusses advanced pulmonary sarcoidosis, antifibrotic uncertainty, and first-line methotrexate data after a CHEST 2026 session.

Pulmonary Fibrosis

Sarcoidosis Care Starts With Inflammation vs Fibrosis: Rohit Gupta, MD

Abigail Brooks is a strategic content lead overseeing 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

The plasmid DNA immunotherapy Voceryq gained FDA accelerated approval after 27% of RRP-001 patients needed no surgery for 12 months.

FDA News

Voceryq Gains FDA Accelerated Approval for Recurrent Respiratory Papillomatosis

Despite new therapies, IgAN still progresses to kidney failure in most patients. The panel reviews who is at greatest risk, which targets matter, and how hematuria fits alongside proteinuria and eGFR.

IgAN Progression Risk: Proteinuria, eGFR Decline, and the Role of Hematuria

Marla Dubinsky, MD, is chief of the division of pediatric gastroenterology and nutrition and co-director of the Susan and Leonard Feinstein IBD Clinical Center, Mount Sinai Kravis Children's Hospital, Icahn School of Medicine.

Marla Dubinsky, MD, discusses phase 3 SHINE-2 data showing mirikizumab induced clinical remission in 41.3% of children with UC by week 12.

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, IBS and IBD, Crohn's disease, and more.

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On the HCPLive inflammatory bowel disease page, resources on the topics of medical news and expert insight into IBD can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBD and more.

SHINE-2 and Closing the Pediatric UC Treatment Gap, With Marla Dubinsky, MD

Jennifer Hsiao, MD, shares how she sets expectations, selects and reassesses biologics, and screens for comorbidities in patients with hidradenitis suppurativa.

Hidradenitis Suppurativa

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Biologic Selection and Comorbidity Screening in HS, With Jennifer Hsiao, MD

Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

IgAN late-breakers led the meeting, alongside new data on aspirin, dialysis access, donor pregnancy, potassium, and depression.

Chronic Kidney Disease

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ASN Kidney Week 2026 Recap: 8 Key Updates in Kidney Disease to Know

Lawrence Eichenfield, MD, discusses phase 2 data showing nemolizumab improved itch, sleep, and quality of life in children 2 to 11 with atopic dermatitis.

What Phase 2 Nemolizumab Data Show in Children 2-11 With Atopic Dermatitis

James Chalmers, MBChB, PhD, discusses an ASPEN post hoc analysis linking sputum color to neutrophil serine protease activity at CHEST 2026.

Latest News

SCD-PED Tied to Higher Survival in Septic AKI, With Stuart Goldstein, MD

Cardiac Health Indicators Improve Following CCM Implantation in Heart Failure

Can a Gene Expression Test Guide Atopic Dermatitis Therapy Selection?

Choosing Between Oral and Injectable PsO Therapy

Overcoming Delays in Systemic Treatment Escalation for PsO