Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

Implantable Portal Insulin Pump Receives FDA Breakthrough Designation

On February 17, 2026, Portal Diabetes’s Portal Pump, an investigational implantable insulin pump system, received Breakthrough Device Designation from the US Food and Drug Administration (FDA). Clinical trials are expected to begin in Q4 2027.

Diabetes Dialogue cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP,  discuss the implications of this device, already being referred to as the first real “artificial pancreas.”

Check out the full episode on implantable insulin pumps and interoperability 

In this segment, Isaacs and Bellini turn to a novel and largely re-emergent concept in diabetes technology: implantable insulin delivery. The discussion is prompted by Portal Diabetes receiving FDA Breakthrough Device designation for its implantable “Portal Pump,” a status intended to accelerate early-phase clinical development for technologies that may significantly improve care. Although implantable pumps are not entirely new—earlier systems developed by MiniMed, now part of Medtronic, were previously available in the United States and remain in limited use in Europe—the hosts emphasize that Portal’s platform represents a modern, potentially transformative iteration.

The segment reviews the physiologic rationale for intraperitoneal insulin delivery. Unlike subcutaneous pumps, which require infusion site changes every few days and depend on pre-meal bolusing to mitigate delayed absorption, the implantable system would deliver insulin directly into the peritoneal space, allowing rapid entry into the bloodstream. The hosts underscore that insulin delivered via this route has a markedly faster onset and offset—on the order of minutes—more closely approximating endogenous pancreatic insulin secretion. Clinically, this could reduce or eliminate the need for pre-bolusing, decrease postprandial excursions, and substantially lower the cognitive burden associated with carbohydrate estimation and dose timing. The rapid pharmacokinetics may also improve safety during exercise by limiting prolonged insulin activity and reducing hypoglycemia risk.

A central point of differentiation from prior implantable systems is Portal’s plan to pursue a fully closed-loop model integrated with continuous glucose monitoring. Earlier devices required meal announcements and user input, whereas this next-generation approach aims to automate insulin delivery entirely. The hosts note that while current “artificial pancreas” systems reduce workload, they remain hybrid systems; a fully automated implantable platform could meaningfully shift the paradigm toward true physiologic replacement and burden reduction.

The conversation also addresses practical and technical considerations. The device would be surgically implanted in the abdomen, with insulin refilled in-office via a transcutaneous port approximately every 6–12 weeks. Portal is reportedly developing a proprietary, temperature-stable, concentrated insulin formulation to maximize the longevity of the reservoir. However, questions remain regarding optimal insulin concentration (e.g., U-500 or higher), micro-dosing precision, device size, infection risk, leakage prevention, long-term safety, and cost-effectiveness.

Isaacs and Bellini conclude with measured optimism, recognizing both the substantial engineering and economic hurdles ahead and the potential for this technology to represent a meaningful advance in automated, physiologic insulin delivery.

Editor’s Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.

Portal Diabetes. Portal Diabetes Gets FDA Breakthrough for Pump, Starts Insulin Study. 

 February 17, 2026. Accessed February 23, 2026. 

https://www.prnewswire.com/news-releases/portal-diabetes-gets-fda-breakthrough-for-pump-starts-insulin-study-302688912.html

Videos

Diabetes Dialogue cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the Portal Pump's recent Breakthrough Designation from the FDA.

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Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives is a monthly podcast hosted by Diana Isaacs, PharmD, and Natalie Bellini, DNP, aimed at providing a regular roundup of the latest clinically applicable insights across diabetes and metabolic diseases, with a focus on leveraging technology to improve care.

Strategic Alliance Partnership

Mauro Cancian, MD, PhD, head of the allergy division at the University of Padua.

 HAE Guidelines Reinforce Early On-Demand Treatment, With Mauro Cancian, MD, PhD

place renewed emphasis on early, on-demand treatment.

The guidelines recommend sebetralstat (Ekterly), an oral plasma kallikrein inhibitor approved by the 

 in July 2025, as a first-line option for the acute treatment of attacks in patients aged ≥ 12 years.

, Mauro Cancian, MD, PhD, head of the allergy division at the University of Padua, discussed how data from the phase 3 KONFIDENT study contributed to this guideline change.

“The result has been very interesting, because there has been a reduction in the interval between onset of symptoms and treatment compared with previous, available treatments that were only injectable,” Cancian said.

KONFIDENT, which assessed sebetralstat in adolescents and adults with HAE, showed that the drug is very quick at stopping disease progression and improving symptoms. As of January 31, 2025, investigators found that the median time from attack onset to treatment was 4 minutes, the median time to the beginning of symptom relief was 1.79 hours, to the reduction in severity was 3.53 hours, and to complete attack resolution was 15.09 hours.

 In the open-label extension, treatment delays were shorter, which Cancian attributed in part to the portability and ease of administration of sebetralstat.

“[The] main delay now is less than 10 minutes,” Cancian said. “That's not a delay. [It] is really every treatment because…10 minutes is the time you…recognize that an attack is happening.”

HAE due to C1 esterase inhibitor deficiency is characterized by recurrent, bradykinin-mediated swelling that can involve the extremities, gastrointestinal tract, and airway. Historically, acute treatment options have required intravenous or subcutaneous administration, including plasma-derived or recombinant C1 inhibitor and the bradykinin B2 receptor antagonist icatibant.

 These agents are effective but may introduce practical barriers that delay administration outside clinical settings.

Cancian cautioned that long-term prophylaxis, though increasingly effective, does not eliminate breakthrough attacks. Therefore, reliable on-demand treatment remains essential even for patients receiving preventive therapy.

Limitations remain, including the absence of head-to-head trials comparing oral and injectable agents and the need for additional real-world effectiveness data. Pediatric use is currently limited to patients aged ≥ 12 years.

Overall, the updated guidelines formalize a management strategy centered on early intervention, individualized care, and maintaining quality of life.

“What we are emphasizing with our patients, and obviously as a result of the guideline, is that to make [a] more effective treatment, you have to treat [the attacks] as early as possible,” Cancian said. “That means treating at the onset of the attack because we know that if there is a delay between attack onset and treatment, the drug will be less effective in reducing both the severity and the duration of the attacks.”

Farkas H, Martinez-Saguer I, Bork K, et al. International Guideline on the Diagnosis and Management of Pediatric Patients With Hereditary Angioedema. 

Johnson V. Sebetralstat FDA-Approved as First Oral, On-Demand for Hereditary Angioedema. HCPLive. Published on July 7, 2025. Accessed on February 23, 2026. 

https://www.hcplive.com/view/sebetralstat-fda-approved-as-first-oral-on-demand-for-hereditary-angioedema

KONFIDENT investigator Cancian discusses oral sebetralstat’s role in the updated HAE treatment guidelines.

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

HAE Guidelines Reinforce Early On-Demand Treatment, With Mauro Cancian, MD, PhD

Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? 

MAJESTY: Obinutuzumab Achieves 2 Year Complete Remission in Primary Membranous Nephropathy

Obinutuzumab demonstrated superior complete remission rates at 2 years compared with tacrolimus in primary membranous nephropathy in the phase 3 MAJESTY trial, supporting a potential new B-cell–targeted standard of care.

Ixekizumab, Tirzepatide Effective Together for Psoriasis and Obesity or Overweight

In adults with moderate-to-severe plaque psoriasis and obesity or overweight, combination therapy with ixekizumab and tirzepatide achieved superior skin clearance and weight reduction at 36 weeks compared with ixekizumab alone.

AREXVY Vaccine Reduces Hospitalization, Major Adverse Cardiovascular Events in RSV

Real-world data from over 2.5 million patients showed GSK’s AREXVY vaccine was 75.6% effective against RSV-related hospitalization, with additional signals suggesting reduced in-hospital major adverse cardiovascular events in older adults.

COMP360 Psilocybin Meets Primary Endpoint in Second Phase 3 Trial for TRD

COMP360 synthetic psilocybin met the primary endpoint in its second phase 3 trial in treatment-resistant depression, demonstrating significant symptom reduction at week 6 versus low-dose control and advancing toward potential regulatory submission.

Thykamine Shows Disease-Modifying Potential in MASH Using Liver-on-a-Chip Platform

Preclinical data using a human liver-on-a-chip model suggest Thykamine may exert dose-dependent antifibrotic and anti-inflammatory effects in MASH, supporting further translational development.

Articles

Multiple late-breaking data sets highlight advances across immunology, metabolic disease, vaccines, neuropsychiatry, and liver fibrosis. In primary membranous nephropathy, B-cell depletion with obinutuzumab produced higher 2-year complete remission than tacrolimus, suggesting a practice-shifting option. For patients with plaque psoriasis plus obesity/overweight, ixekizumab combined with tirzepatide improved PASI responses and weight loss versus ixekizumab alone. Real-world effectiveness analyses support AREXVY in preventing RSV hospitalization and suggest fewer in-hospital MACE. Synthetic psilocybin (COMP360) achieved a second phase 3 primary endpoint in TRD. Liver-on-a-chip work indicates antifibrotic potential for Thykamine in MASH.

An audio recap of the top 5 stories in healthcare news from the week of 02/15-02/21.

Nephrology

The HCPLive nephrology page is a resource for medical news and expert insights on kidney disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in nephrology, and more.

Plaque Psoriasis

The HCPLive plaque psoriasis page is a resource for medical news and expert insights on psoriasis. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for psoriatic disease, and more.

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Cardiology

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MASH / MASLD

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Hepatology

HCPLive 5 Stories in Under 5: Week of 02/15

Mary K Roberts, PhD is a Post Doctoral Researcher at the Leverhulme Centre for Demographic Science at the University of Oxford.

Donor–Recipient Closeness and Perceived Life Extension Drive Living Kidney Donation Decisions

New data from a US-based survey suggest the closeness of the donor–recipient relationship and perceived health benefits for the recipient may be strong motivators for living donors, with insights that could inform counseling strategies in transplant programs.

There are 90,000 individuals awaiting kidney transplants in the US alone, making up 86-87% of the national transplant waiting list. In 2025, the US achieved a record of organ transplants, with a 3% increase in individuals becoming living organ donors, according to data from the Organ Procurement and Transplantation Network. Living donor kidney transplantation has been associated with superior graft survival and improved patient outcomes for patients with ESKD, rates of living donation remain low.

“One of the major gaps in the living donation literature that we were really focused on was that most research examines barriers from the patient or provider perspective,” Mary K Roberts, PhD, Post Doctoral Researcher at the Leverhulme Centre for Demographic Science at the University of Oxford, explained. “We know much less about the donor side, especially in the US, and prior studies have mostly focused on financial concerns.”

In the analysis, Roberts and investigators leveraged data from 600 US relatives of patients with kidney disease who completed the 2019 Families of Renal Patients Survey. In the survey, participants rated 14 considerations, including financial, health, and relational factors, which affected their willingness to be evaluated as living donors.

Older adults were less likely than younger respondents to report reduced willingness for financial reasons, while younger adults more often reported increased willingness based on match likelihood, current health, and knowledge of living donation. Older respondents more often indicated that their own health reduced willingness, and adults aged 40 to 59 most often cited negative effects on their family.

Women were more likely than men to report reduced willingness related to financial and recovery concerns. Asian or Pacific Islander and Black respondents more often reported reduced willingness due to financial issues and the surgery itself, while Hispanic and White respondents more often reported increased willingness related to extending the recipient’s life.

Greater willingness related to match likelihood, current health, the donor–recipient relationship, and the potential to extend the recipient’s life was associated with completing more donation-related actions. Lower willingness tied to general views on organ donation, surgery, or recovery was associated with completing fewer actions.

After adjustment for demographic factors and relationship to the patient, significant associations remained for match likelihood, current health, the donor-recipient relationship, the potential to extend the recipient’s life, and general views on organ donation.

“The findings really suggest that counseling centered around relational and health related motivations tend to really drive action,” said Roberts. “So prior to evaluation, it would be important to explore donor-recipient relationships and acknowledge that, you know, interpersonal closeness might be a motivator for a lot of donors.”

Roberts MK, Ryan-Claytor C, Salim Z, Kirk JM, Rowe-Nicholls I, Daw J. Factors influencing willingness to pursue living kidney donation among relatives of patients with kidney disease in the United States. 

. Published online February 9, 2026. doi:

https://doi.org/10.1186/s12882-026-04806-3

90,000 people are waiting for a kidney. Here’s one way to get them a kidney faster. - UNOS. UNOS. Published January 27, 2025. 

https://unos.org/news/90000-people-are-waiting-for-a-kidney-heres-one-way-to-get-them-a-kidney-faster/

Survey of 600 US relatives finds donor–recipient closeness and expected life extension drive living kidney donation more than financial concerns.

Donor–Recipient Closeness, Perceived Life Extension Drive Living Kidney Donation Decisions, With Mary Roberts, PhD

The First Interoperable Implanted CGM: The Eversense 365 and Twiist Insulin Pump

On February 16, 2026, parent companies Sequel Med Tech and Senseonics announced and launched a combination of the Twiist automated insulin delivery system and the Eversense 365, the first and only 1-year implantable continuous glucose monitor (CGM). This interoperability opens many doors for patients currently using the Eversense 365 for type 1 diabetes (T1D).

Diabetes Dialogue cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the announcement and its implications for patients seeking lower-maintenance CGM options.

In this segment, the hosts turn their attention to the full commercial launch of the Eversense 365 CGM system integrated with the Twiist insulin pump, marking the first officially available pump partnership for the one-year implantable CGM. While an early release phase had already begun, the system is now broadly accessible, representing a meaningful expansion in diabetes technology options. The discussion situates this development within the broader theme of patient-centered device selection, underscoring that no single pump or sensor is optimal for all individuals with diabetes.

A central focus of the conversation is the clinical and experiential value of the Eversense 365 system. Unlike traditional transcutaneous CGMs requiring replacement every 7 to 15 days, the implantable sensor remains in place for up to one year, eliminating the recurring burden of frequent insertions and the variability often associated with “day one” sensor performance. Although initial calibrations are required, ongoing calibration frequency has been reduced to approximately once weekly, which the hosts describe as a manageable tradeoff for many patients. Importantly, after the early calibration phase, users no longer experience routine warm-up periods with each new sensor cycle.

The removable external transmitter is highlighted as a distinguishing feature. Because it sits atop the skin and can be detached temporarily, users can remove it during activities or simply take a break from wearing visible hardware, then reattach it to obtain readings. This flexibility may appeal to patients seeking intermittent device-free intervals without sacrificing long-term sensor continuity.

Accuracy and reliability are also emphasized. The hosts note strong performance metrics and specifically reference the absence of “pressure lows,” a phenomenon observed with some interstitial CGMs when external compression affects glucose readings. For individuals with skin sensitivity, adhesion challenges, or recurrent accuracy concerns related to sensor placement, the implantable system may offer a clinically meaningful alternative.

Finally, Isaacs and Bellini reflect on the broader implications of pump integration. Previously, lthe ack of pump connectivity limited adoption among patients committed to automated insulin delivery systems. With Eversense now communicating directly with a commercial pump, the potential user base may expand. The hosts conclude by expressing interest in whether additional pump manufacturers will pursue similar collaborations, suggesting that this milestone may catalyze greater interoperability and reinforce the importance of individualized, choice-driven diabetes technology strategies.

Senseonics. Sequel Med Tech and Senseonics Launch Transformative Combination of twiist and Eversense 365. February 19, 2026. Accessed February 23, 2026. 

https://www.senseonics.com/investor-relations/news-releases/2026/02-19-2026-130316928

Diabetes Dialogue cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the recent release of the Eversense 365 by Sequel Medtech and Senseonics, paired with the Twiist insulin pump.

Type 1 Diabetes

Seralutinib did improve 6-minute walk times and biomarkers, especially in patients with higher-risk disease.

Pulmonology

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

PROSERA: Seralutinib Falls Short in Pulmonary Arterial Hypertension Phase 3 Trial

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.

Luspatercept met primary endpoints in transfusion-dependent and non–transfusion-dependent alpha-thalassemia.

Hematology

Luspatercept Meets Primary Endpoints in Phase 2 Alpha-Thalassemia Trial

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

This approval of the Allurion Gastric Balloon System, incorporating the Allurion Smart Capsule, is indicated for weight loss management for those with obesity.

FDA News

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FDA Grants Premarket Approval to Allurion Gastric Balloon System for Weight Loss

Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

The phase 3 REDEFINE 4 trial saw CagriSema achieve 23% weight loss, but fail to demonstrate noninferiority to tirzepatide in patients with overweight or obesity.

CagriSema Demonstrates Weight Loss, Fails to Achieve Primary Endpoint Compared to Tirzepatide

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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 FDA has granted both designations to TSRA-196, an in vivo gene editing program from Tessera Therapeutics, for the treatment of PiZZ alpha-1 antitrypsin deficiency.

Alpha-1 antitrypsin deficiency

TSRA-196 Gets FDA Fast Track, Orphan Drug Designations for AATD

Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

FDA clears iloperidone metabolite, milsaperidone, for acute bipolar I disorder and schizophrenia, expanding treatment options.

Psychiatry

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FDA Approves Milsaperidone for Acute Bipolar I Disorder, Schizophrenia

Podcasts

Cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the recent release of Eli Lilly's Zepbound as an injectable with the KwikPen.

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Diabetes Dialogue: Launch of the Zepbound KwikPen

Frances Lee, MD, is an assistant professor of medicine in the division of liver diseases at Mount Sinai.

New studies reveal potential benefits of alfagimor in reducing fatigue and pruritus, highlighting its role in second-line therapy for patients.

New Fatigue Signals From Elafibranor: Results From the ELATIVE Phase III Trial

In this episode, experts delve into the limited treatment options to address the symptom of fatigue in patients with primary biliary cholangitis. They highlight how small changes, like regular sleep schedules and exercise, can improve fatigue.

Addressing Fatigue: Traditional Management Outside Primary Therapy

The CUPID-C randomized clinical trial confirmed CUPID-A results, with dupilumab significantly reducing urticaria in anti-IgE–naive individuals with CSU.

Urticaria

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Latest News

Implantable Portal Insulin Pump Receives FDA Breakthrough Designation

HAE Guidelines Reinforce Early On-Demand Treatment, With Mauro Cancian, MD, PhD

HCPLive 5 Stories in Under 5: Week of 02/15

Donor–Recipient Closeness, Perceived Life Extension Drive Living Kidney Donation Decisions, With Mary Roberts, PhD

The First Interoperable Implanted CGM: The Eversense 365 and Twiist Insulin Pump