Today's Healthcare Pulse
FDA greenlights durvalumab combo for high‑risk bladder cancer
The FDA approved durvalumab (Imfinzi) combined with Bacillus Calmette‑Guerin for BCG‑naïve, high‑risk non‑muscle invasive bladder cancer. The POTOMAC trial enrolled 1,018 patients and showed a 32% reduction in disease recurrence risk (hazard ratio 0.68, p=0.015). Durvalumab is given at 1,500 mg IV every four weeks for up to 13 cycles.
Also developing:
By the numbers: Apogee Therapeutics raises $1.3B royalty financing
Designing Telehealth for Every Age: What Providers Need to Know About Serving Older Adults
Telehealth’s rapid expansion has left older adults behind because most platforms ignore age‑related cognitive, sensory, and usability challenges. Studies show that while over half of seniors are interested in video visits, only a third feel comfortable using them, highlighting a design‑driven gap. Age‑inclusive interfaces—large fonts, high‑contrast visuals, streamlined steps—and caregiver‑friendly features can dramatically improve virtual care experiences. Clinician training that emphasizes empathy and aging‑specific communication is equally critical to delivering equitable telehealth.
Cross‑check AI Answers and Heed Red‑flag Symptoms
@PBS: Five things to consider before asking a chatbot for health advice (by @AP_FDAwriter). Among them: ask two different AIs and see if they agree; don't stay home if you have red flag symptoms like chest pain, shortness of breath....
Latest TechBio News
Proscia has been crowned the top‑performing digital pathology software vendor in the United States, receiving a 95.2 overall score in KLAS Research’s 2026 report and earning A+ or A grades across all six customer‑experience pillars. The company is also the...
Navigating the FDA After the Storm To Advance Drug Candidates
After a wave of senior departures and a 3,500‑position cut, the FDA entered 2026 with a largely inexperienced workforce, raising uncertainty for drug developers. The agency’s new AI guidance, released in January, outlines best practices but emphasizes human oversight and...
Clinicians Discuss Real-World AI Applications on Zoom
I’ll be joining a Zoom discussion hosted by Roon on March 5, 1:30-2:30 ET. We'll discuss how clinicians are using AI in actual practice and the implications. I'll be joined by 3 eminent colleagues: Mandy Cohen, Sara Murray, & Spencer...
How Hands-On Medical Training Prepares You For Real Clinics?
Hands‑on medical assistant programs, like Allen School’s, immerse students in real‑clinic environments, letting them practice patient interviews, vital‑sign collection, and equipment use under supervision. Repeated simulations of appointment flow, teamwork, and electronic record entry turn theoretical knowledge into muscle memory...
60% Of Older Adults Prefer At-Home Care If Their Needs Increase
A Pew Research survey of 2,582 U.S. adults aged 65 and older finds that 60% would rather stay at home with a caregiver if they can no longer live independently, while only 18% prefer moving to an assisted‑living community. Preference...
Repeal Of Motorcycle Helmet Laws Are Dangerous And Expensive
A University of Michigan study examined the impact of Michigan’s 2022 repeal of its universal motorcycle‑helmet law. Researchers found hospital costs rose by $5,785 per injured rider—a 26% increase—adding more than $4.5 million in annual expenses, or $6.4 million when adjusted to...
FDA Clears Ultrasound AI Tool for Accurate Delivery-Date Prediction
The U.S. Food and Drug Administration granted De Novo clearance to Ultrasound AI’s Delivery Date AI, a cloud‑based software‑as‑a‑medical‑device that predicts a pregnant woman's delivery date using only standard ultrasound images. The model was trained on more than one million...
Where Are the Doctors? Patients Leading the Conversation on TikTok About Hidradenitis Suppurativa in Skin of Color
A new JMIR Dermatology study finds TikTok is the primary education source for patients with hidradenitis suppurativa (HS) in skin of color. Researchers analyzed 50 videos and discovered that nearly half were patient‑generated, while only about 20% featured dermatologists. Physician‑authored...
908 Devices Inc (MASS) Q4 2025 Earnings Call Transcript
908 Devices reported Q3 2025 revenue of $14 million, a 4% year‑over‑year decline but an 8% sequential increase, driven largely by FTIR‑based Explorer devices. Adjusted EBITDA loss narrowed to $1.8 million, a 53% quarter‑over‑quarter improvement, marking the smallest loss since the company...
Cryoport Inc (CYRX) Q4 2025 Earnings Call Transcript
CVRx reported fourth‑quarter 2025 revenue of $16 million, a modest 4% year‑over‑year increase, while gross margin improved to 86% driven by higher selling prices and manufacturing efficiencies. Net loss widened to $11.9 million as SG&A and R&D expenses outpaced revenue growth, but...
Evolus Inc (EOLS) Q4 2025 Earnings Call Transcript
Evolus Inc. reported fourth‑quarter 2025 net revenue of $90.3 million, a 14% year‑over‑year increase, and full‑year revenue of $297.2 million, marking a sixth consecutive double‑digit growth year. Jeuveau drove the bulk of sales, achieving over 14% U.S. market share, while the newly...
Neuropace Inc (NPCE) Q4 2025 Earnings Call Transcript
NeuroPace reported fourth‑quarter 2025 revenue of $26.6 million, a 24% year‑over‑year increase driven primarily by a 26% rise in RNS system sales to $22.4 million. Gross margins improved to 77.4% overall and 80.5% for the RNS product, while operating expenses grew slower...
SOPHiA GENETICS SA (SOPH) Q4 2025 Earnings Call Transcript
SOPHiA GENETICS reported Q4 2025 revenue of $19.5 million, up 23% year‑over‑year, marking the third consecutive quarter of accelerating growth. The company added 31 new customers, bringing total 2025 signings to 94, and saw U.S. revenue rise 30%, highlighting strong market...
Investors Welcome Bradesco Healthcare Shakeup
Brazilian financial giant Bradesco announced it will consolidate all of its healthcare holdings into a single, publicly listed division. The restructuring creates a dedicated health platform that will house hospitals, insurance operations, and ancillary services under one corporate umbrella. Investors...
NDA and BLA Calendar Year Approvals
The FDA’s Center for Drug Evaluation and Research (CDER) has published its annual New Drug Application (NDA) and Biologics License Application (BLA) approval reports for calendar years 2015 through 2025, each linked in a consolidated list. These reports detail the...
Colorado Leads, Washington Should Follow on Insulin Caps
In Colorado, we’ve been laser focused on saving Coloradans money on prescription drugs since day one, and it’s past time that Washington catches up. Colorado was the first state to cap insulin costs long before the federal government and expand...
Cost and Trust Drive Post-Acute Care Decisions, Nursing Home Choices – U.S. News Survey
The U.S. News survey of 206 recent discharges found trust to be the dominant factor—93% rated it extremely or very important—slightly outweighing clinical quality. Cost was the top driver when choosing between home health and skilled nursing, yet many respondents...
Miriam Paramore, RxUtility
In a quick‑bite interview at the February 2026 VIVE conference, Miriam Paramore discussed RxUtility, a health‑tech platform that consolidates manufacturer coupons and cash‑price data to present consumers with the lowest possible drug price at the point of dispensing. The solution...
5 Notable Health Tech Funding Announcements in February
February saw a wave of sizable health‑tech financings, with Talkiatry closing a $210 million Series D, Honest Health raising $140 million, Solace securing $130 million in Series C, Garner Health obtaining $118 million in Series D, and Midi Health completing a $100 million Series D that pushes its valuation...
Frontline Honors Award Winner: Ashley Lott, Certified Nursing Assistant, Litchfield Health & Rehab Center
Ashley Lott, a Certified Nursing Assistant at Litchfield Health & Rehab Center, has been named to the Frontline Honors Awards Class of 2025 by Skilled Nursing News. The award, driven by peer nominations, recognizes frontline workers who deliver exceptional resident...
New Diagnostic Markers for Multiple Sclerosis Discovered in Cerebrospinal Fluid
Researchers from the Max Planck Institute of Biochemistry and the Technical University of Munich applied high‑throughput mass spectrometry to cerebrospinal fluid from more than 5,000 patients, measuring roughly 2,000 proteins per sample. They identified a 22‑protein panel that distinguishes multiple...
What ‘The Pitt’ Gets Right About Obesity That Real Medicine Often Misses
A recent episode of the TV drama *The Pitt* highlighted a stark contrast between typical obesity‑related bias in medical settings and a model of care that treats the patient’s acute condition without judgment. The show depicted clinicians adapting equipment and...
One PSMA Agent Outshines Competitors at Detecting Prostate Cancer Recurrence
A head‑to‑head study of 55 post‑prostatectomy patients compared two FDA‑cleared PSMA PET agents, Posluma (flotufolastat F‑18) and Pylarify (piflufolastat F‑18). Posluma demonstrated markedly lower bladder radioactivity, with a median bladder SUV of 10.9 versus 29 for Pylarify. This reduction translated into higher...
Frontline Honors Award Winner: Vanessa Valerio, RN, CMC, CHCA, Vice President and Chief Operating Officer, Care Indeed
Vanessa Valerio, RN, CMC, CHCA, Vice President and COO of Care Indeed, has been named to the Frontline Honors Awards Class of 2025 by Home Health Care News. The award recognizes frontline workers who deliver exceptional experiences, advocate for the...
How Flatworms Keep Their Regeneration Powers on Track
Scientists have identified a molecular checkpoint that guides planarian stem cells during regeneration. The roundabout A receptor (RoboA) suppresses inappropriate pharyngeal differentiation by regulating the transcription factor FoxA, while the extracellular protein Anosmin1a partners with RoboA to fine‑tune cell identity...
Ultrasound-Activated 'Nanoagents' Kill Superbugs Hiding in Biofilms
Scientists at the University of Birmingham and Nottingham Trent University have created silica‑based nanoagents that encapsulate the hydrophobic antibiotic rifampicin and release it only when exposed to low‑frequency ultrasound. The ultrasound‑triggered particles penetrate deep into Staphylococcus aureus biofilms, achieving a...
Plan to Attend 2026 AHA Annual Meeting
The American Hospital Association (AHA) is intensifying its policy engagement ahead of the 2026 AHA Annual Meeting, issuing recommendations on health data deregulation and technology interoperability. It submitted statements to multiple congressional hearings, addressing physician burnout, health‑care cost reduction, and...
FDA Adverse Event Reporting System (FAERS) Electronic Submissions
The FDA has mandated electronic submissions to the FAERS database using the ICH‑endorsed E2B(R3) standard, beginning January 16 2024 for post‑marketing drug and biologic reports and April 1 2024 for pre‑marketing IND safety reports. Companies have until April 1 2026 to transition fully, after which only...
AHA’s Hood Shares How Governance, Trust Can Shape Health Care Organizations
American Hospital Association’s Trustee Insights features Executive Vice President and COO Michelle Hood, who draws on four decades of leadership to discuss how strong governance, trust, and active board engagement can build resilient health‑care organizations. The piece underscores the need...
Report: Colorectal Cancer Rates Continue Declining Among Older Adults While Incidents Climb for Younger Adults
A new American Cancer Society report shows colorectal cancer rates keep falling among adults 65 and older, while incidence climbs sharply for younger adults. The surge in younger patients is driven by a rise in rectal cancer, now accounting for...
Insurance Exec: ‘We Are All To Blame’ For Failure Of US Health System
Ascendiun CEO Paul Markovich announced Worthy, a new lobbying effort funded by his company to overhaul the U.S. health‑care system. The initiative, launched with Mark Cuban, targets insurer‑driven inefficiencies such as outdated provider directories, burdensome prior‑authorization, and excessive administrative costs. Markovich...
How Healthcare Organizations Can Build Ransomware Resilience
Scott Doerr, virtual CISO at Fortified Health Security, will present a session on ransomware resilience at HIMSS 2026. He outlines a phased approach that moves ransomware from a reactive crisis to a managed operational risk, emphasizing assessment, planning, simulation, execution,...
Your Insurance Said No? Here's How to Win the Appeal #CareTalk
The latest #CareTalk episode highlights free AI tools that help patients draft professional appeal letters after insurance denials. Counterforce Health demonstrates how these tools can address prior authorization refusals, claim rejections, and claims of non‑medical necessity. Guests Diane Archer and...
VA Health Care: Recommendations and Observations to Improve Community Care and Support for Caregivers Related to the Dole Act
GAO reports that the Veterans Health Administration has yet to fully implement recommendations aimed at improving the Veterans Community Care Program and Caregiver Support Program, as mandated by the 2025 Dole Act. Staffing shortfalls, missing wait‑time metrics, and inconsistent referral...
Bysanti FDA Approval for Bipolar I and Schizophrenia Marks Vanda’s Second Win in Two Months
Vanda Pharmaceuticals received FDA approval for Bysanti (milsaperidone) to treat acute manic or mixed episodes of bipolar I disorder and schizophrenia in adults. The approval introduces a new chemical entity in the atypical antipsychotic class that is bioequivalent to Vanda’s...
Rising Pediatric Diabetes Trends in US Medicaid, CHIP Enrollees
New JAMA Network Open analysis shows pediatric diabetes prevalence among Medicaid and CHIP enrollees rose from 2.73 to 3.04 per 1,000 between 2016 and 2021, an 11.4% increase. Type 2 diabetes drove most of the growth, climbing 24.3% with especially sharp...
FDA's Adverse Event Reporting System (FAERS)
The FDA Adverse Event Reporting System (FAERS) is a public database that collects adverse event, medication error, and product quality complaint reports for drugs and biologics after market approval. It follows the ICH E2B international safety reporting guidance and uses...
Early Add-On Therapy Associated With Strong Clinical Response in MG
A multicenter retrospective registry of 153 AChR‑positive generalized myasthenia gravis patients found that initiating add‑on immunotherapy within 24 months of diagnosis (early intensified treatment) produced faster and larger improvements in MG‑ADL, QMG, and quality‑of‑life scores than later escalation. Early patients...
Data From Insight Hospital and Medical Center Leaked on Dark Web
Insight Hospital and Medical Center disclosed that an unauthorized actor accessed its network from August 22 to September 11, 2025, compromising extensive personal and health data. The breach involved roughly 360 GB of files—about 900,000 records—including names, Social Security numbers, and medical images. On...
Tampa General Hospital Adopts LIBERTY Endovascular Robotic System
Tampa General Hospital has become the first health system in Florida to adopt Microbot Medical’s LIBERTY Endovascular Robotic System, following the device’s FDA 510(k) clearance. LIBERTY is a single‑use, remotely operated robot designed for peripheral endovascular procedures, promising greater precision...
Ultrasound Isn't Cutting It for Diagnosing Pediatric Appendicitis, New Data Show
A recent analysis in Emergency Radiology compared ultrasound, CT, and rapid MRI for diagnosing pediatric appendicitis. Ultrasound was nondiagnostic in over half the cases, delivering only 65.3% sensitivity, while rapid MRI achieved 96‑97% sensitivity and 98% specificity. Although ultrasound resulted...
P‑tau 217 Blood Test Outperforms Total P‑tau 217 For
The breakthrough blood test p-tau 217 for risk and diagnosis of Alzheimer's disease is more accurate than total p-tau 217, in a head-to-head comparison using PET imaging https://t.co/faILpVr9Ua https://t.co/lzUgFnFUP5
Ultrasound Reporting Platform Gets FDA Approval
AS Software announced that its next‑generation ultrasound reporting platform, Asera, received 510(k) clearance from the U.S. Food and Drug Administration. The cloud‑based solution retains core reporting functions while delivering a redesigned user interface, streamlined workflows, and scalable architecture. Asera includes...
Pharma Pulse: Regulatory Speed Records
Boehringer Ingelheim’s oral kinase inhibitor Hernexeos received FDA accelerated approval for first‑line HER2‑mutant lung cancer in a record‑fast 44 days, thanks to the National Priority Voucher program. The drug demonstrated a 76 % response rate, positioning it as a breakthrough in personalized...
Rethinking Idiopathic Pulmonary Fibrosis: Unmet Needs, Evolving Biology and the Future of Clinical Research
Idiopathic pulmonary fibrosis (IPF) continues to pose a severe, often late‑diagnosed respiratory challenge, with mortality exceeding many cancers. Boehringer Ingelheim’s Martin Beck highlighted the shift toward earlier detection using AI‑enhanced imaging and a broader view of IPF as a heterogeneous,...
No Evidence Bans Improve Minors' Mental Health
"There is no scientific evidence to support the assumption that banning minors from accessing services would have a positive effect on their mental health and development." https://t.co/eOCmTZvNiE
Water Interactions Reveal How Surface Coatings Reshape Nanoparticle Drug Delivery
Arizona State University researchers quantified how water interacts with biomolecule‑coated magnetite nanoparticles, revealing that surface coatings dramatically reshape hydration energetics, immune recognition, and drug‑delivery performance. Using a calorimetry‑gas adsorption system, they measured water adsorption on particles coated with bovine serum...
Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets
The FDA issued a final guidance document outlining best practices for conducting and reporting pharmacoepidemiologic safety studies that rely on electronic healthcare data, such as administrative claims and electronic medical records. It prescribes how sponsors should document study design, analytical...