Today's Healthcare Pulse
Lawmakers push to codify wearable device regulations
U.S. legislators are consulting with wearable‑device stakeholders to draft legislation that would codify existing FDA guidance into law, creating a clear regulatory pathway for fitness trackers and smart watches that fall outside the current medical‑device definition.
Also developing:
By the numbers: Kardigan targets $1.4B valuation in US IPO
Learning From FDA’s Moderna U-Turn
The FDA abruptly reversed its decision to approve Moderna’s mRNA‑based flu vaccine after the White House intervened, sparking intense discussion in biotech boardrooms. The reversal was driven by political considerations rather than new scientific data, underscoring the agency’s vulnerability to external pressure. Analysts note that while the move highlights the power of executive influence, it does not provide a template for other firms to sway regulatory outcomes. The episode raises fresh concerns about predictability in the U.S. drug approval process.
Clinical AI Offers Hope: More Impact, Less Complexity
"This is the first time where there's hope - there is a pathway to doing more with less. There is a pathway for the job of being a clinician, being a nurse, to be a fulfilling one. There is a...
Navigating the Expanding MS Treatment Landscape: Kavita Nair, PhD
The multiple sclerosis (MS) treatment landscape has exploded from four to 23 disease‑modifying therapies, giving clinicians a broad menu of oral, injectable, infusion, generic, and biosimilar options. Selecting a therapy now hinges on balancing efficacy and safety with real‑world factors...
Novartis Breaks Ground on $23B Biomedical Research Hub in San Diego
Novartis began construction of a new biomedical research hub in San Diego. The 466,000‑sq‑ft center, part of a $23 billion US R&D and manufacturing program, will house about 1,000 researchers and target neuroscience, oncology, global health, and age‑related diseases. Scheduled to...
Croom Medical Breaks Ground on R&D Site in Ireland
Croom Medical has broken ground on ACOT, a 38,000‑square‑foot Advanced Centre of Orthopaedic Technologies in Croom, County Limerick. The project represents the company’s largest capital outlay in its 42‑year history and will serve as a combined R&D and industrialisation hub....
WestFax Launches AI-Powered Intelligent Document Processing Platform for Healthcare
WestFax launched Comprehend, an AI‑powered Intelligent Document Processing platform for healthcare, now available across all its service tiers. The solution uses OCR, AI and FHIR‑aligned models to convert inbound fax, email and file‑based documents into searchable PDFs, classify types, and...
How to Avoid a Fall by Balancing Cost and Performance in Drug Discovery
Balancing cost and performance in drug discovery requires a hybrid engineering‑led approach that combines on‑premise HPC with scalable cloud resources. Uncontrolled cloud scaling can drive unpredictable expenses, while pure on‑premise systems demand high upfront capital and maintenance. By implementing disciplined...
Elevance Health's Value-Based Care Models Deliver Measurable Quality Gains: Kristie Spencer
Elevance Health reported that 60.5% of its medical spend now flows through value‑based care contracts, with shared‑risk arrangements climbing to 37%—a 4‑point rise from the previous year. The company’s 2024 Advancing Health Together report shows that 76% of its value‑based...
Wet, Dry AMD Require Different Methods of Treatment, Including Anti-VEGF: Julie Rosenthal, MD, MS
Age‑related macular degeneration (AMD) affects roughly 19.8 million Americans and remains a leading cause of blindness. The disease is split into dry and wet forms, each requiring distinct therapeutic approaches. Wet AMD is managed with intravitreal anti‑VEGF injections, with newer agents...
CDC Enterprise Architect to Detail Digital Transformation at HIMSS26
At HIMSS26, CDC Acting Chief Enterprise Architect Ryan M. Harrison will unveil the agency’s Technical Reference Architecture (TRA), a unified framework that codifies IT standards across CDC. The presentation targets both IT leaders and developers, illustrating how the TRA integrates...
Altesa BioSciences Raises $75M Series B
Altesa BioSciences announced an oversubscribed $75 million Series B round, led by Forbion with participation from Sanofi and existing backers Medicxi, Pitango, and Atlantic Partners. The financing will support the development of its lead candidate, vapendavir, targeting viral-driven exacerbations in COPD and...
Topical Adquey (Difamilast) Wins FDA Approval for Atopic Dermatitis
The U.S. Food and Drug Administration has granted approval to Adquey, a 1% difamilast topical ointment, for the treatment of mild-to-moderate atopic dermatitis in patients two years and older. Developed by Otsuka and licensed to Acrotech Biopharma, the product is...
5-Day Preoperative Radiotherapy in High-Risk STS Shows Manageable Toxicity
A phase‑2 single‑center trial evaluated a five‑day pre‑operative radiotherapy schedule in 110 patients with high‑risk soft‑tissue sarcoma. At two‑year follow‑up, grade ≥ 2 radiation‑related toxicities were observed in 14 of 74 evaluable patients, with lower rates in the extension cohort. Major wound...
At an Inflection Point in HIV Science: Nicolas Chomont, PhD, Looks Ahead to CROI 2026
Nicolas Chomont, chair of CROI 2026’s scientific program, previewed the conference’s focus on emerging HIV research, including treatment, cure, and vaccine advances. The meeting will showcase extensive data on long‑acting antiretroviral therapies and address funding constraints affecting global HIV initiatives....
ALIS Releases New Clinical Benchmarking Report Analyzing Data From 28,800 Senior Living Residents
ALIS released its Q4 2025 ALIS 500 Clinical Report, the first senior‑living clinical benchmarking study covering 500 communities and 28,800 residents. The report delivers detailed data on resident age, prevalent chronic conditions, comorbidity patterns, and fall incidents, and is paired with an...
Health Equity & Access Weekly Roundup: February 20, 2026
The Guttmacher Institute reports a modest 2% drop in abortion clinics across non‑ban states, yet high churn—51 closures and 39 openings—creates instability, especially in Florida where a six‑week ban accelerated losses despite telehealth growth. New sickle‑cell disease therapies, including gene‑editing...
Sana Health Clears a Major Milestone in the Fight Against Chronic Pain
In this episode, Richard Hanbury of Sana Health discusses the company’s recent FDA De Novo clearance for a novel audio‑visual neuromodulation device targeting neuropathic pain, marking the creation of a new therapeutic class. He outlines decades of research that led...
How Hospitals and Area Agencies on Aging Are Collaborating to Advance Social Connection
Hospitals and Area Agencies on Aging (AAAs) are launching joint programs to combat social isolation among older adults, a risk heightened by the fact that one‑fifth of Americans 50+ live alone. The collaborations leverage community health workers, technology platforms, and...
GoFundMe CEO on Why Crowdfunding Sparks Generosity and Judgment
GoFundMe’s CEO Tim Cadogan says health‑related fundraising remains the platform’s top category, with campaigns like the late actor James Van Der Beek’s raising $2.7 million. The company allows anyone facing out‑of‑pocket medical costs to start a fundraiser without disclosing personal financial details. Cadogan and...
CDC Report Highlights Low Use of COVID-19 Antivirals Among People 65 and Older
The CDC’s February 19 MMWR report shows that only a minority of Americans aged 65 and older received FDA‑approved COVID‑19 antiviral prescriptions in recent months. From June 2023 through September 2025, antiviral use was 16‑23% during periods of low community transmission and rose...
Important Takeaways From Medtronic’s (MDT) Q3 2026 Earnings Report
Medtronic reported Q3 2026 adjusted earnings of $1.36 per share, beating expectations, while revenue climbed 8.7% to $9.0 billion, led by a 13.8% surge in its cardiovascular unit. Operating margin slipped to 16.2% from 19.9% as the company intensified R&D spending...
Rural Health Care Crisis: Can Telemedicine Close the Gap?
Since 2005, 195 rural hospitals have shut down, with 50 closures occurring between 2017 and 2023, deepening access gaps for millions of Americans. Rural residents experience higher rates of diabetes, mental distress, and premature mortality, compounded by looming federal Medicaid...
Ten63 Therapeutics Secures New Funding
Ten63 Therapeutics, an AI‑driven drug‑discovery firm spun out of Duke and TTIC, announced a strategic investment from Chugai Venture Fund and the Bill & Melinda Gates Foundation, bringing total capital to over $45 million. The company leverages its BEYOND generative‑chemistry platform...
FDA Approves Expanded Use of Gadolinium-Based Imaging Agent From Guerbet
The U.S. FDA has approved an expanded label for Guerbet’s gadolinium‑based contrast agent Elucirem (gadopiclenol), allowing its use in infants and children under two years, including term neonates. The agent delivers high‑relaxivity imaging with less than half the gadolinium dose...
FDA Cracks Down as Novo Sues Hims over Semaglutide
This is the first reference which I heard directly from FDA commissioner Dr. Marty Makary regarding $HIMS, $NVO 🧵👇and the recent legal actions that the HHS had initiated against HIMs and Hers. When he was asked by @annikakimc - @CNBC’s...
Hormone-Regulated Immune Cells Implicated in Longer Lasting Pain in Women
Researchers at Michigan State University discovered that hormone‑regulated monocytes producing interleukin‑10 (IL‑10) drive faster pain resolution in males. In mouse models, testosterone‑dependent IL‑10+ monocytes cleared inflammatory pain more quickly, while females exhibited fewer of these cells and prolonged pain. Human...
Can Smartphones Replace $25,000 Eye-Testing Gear? This Startup Says Yes
Danish startup OptikosPrime claims its Argus app can generate a full eyeglass prescription using only a smartphone camera. In prototype tests the app achieved a mean absolute error of 0.51 diopters, approaching the 0.25‑diopter threshold of professional autorefractors. The solution...
Ceftriaxone - Injection Products
The latest ceftriaxone injection labeling clarifies susceptibility breakpoints for anaerobic organisms, defining a minimum inhibitory concentration of ≤1 µg/mL as susceptible. For Haemophilus influenzae and H. parainfluenzae, the interpretive criteria assume a 2 g IV dose every 24 hours in patients with normal...
To What Degree Does Cytomegalovirus Contribute to Neurodegenerative Conditions?
Cytomegalovirus (CMV) infection, prevalent in most adults, increasingly appears linked to neurodegenerative processes. Large cohort studies show higher CMV IgG levels correlate with accelerated cognitive decline, and post‑mortem analyses detect CMV DNA in a majority of vascular dementia brains. Animal...
Reviewing Locum Tenens Agreements: Look Beyond the Hourly Rate
Dr. Sriman Swarup warns that the hourly rate in locum tenens contracts is often the least critical factor. He emphasizes that contract clarity—especially around responsibility for cancellations, payment guarantees, and termination triggers—determines whether an assignment is viable. Ambiguous language typically...
Teaching Your Own Work Feels Like Self‑Scrutiny
I always feel weird assigning things I'm in. It feels like a weird flex, even when it's actually a good teaching resource. Today my global health class is talking about "the fevers", colonialism, and the beginnings of global health. So I...
HIMSS26 to Host Native American & Indigenous Health Symposium
The HIMSS26 conference will host the fourth Native American & Indigenous Health Symposium, bringing together tribal and Indigenous health leaders from the U.S., Canada, Australia and Alaska. Since its 2022 launch, the HIMSS Indigenous Community has expanded its network and...
The Most Interesting FHIR You've Never Heard Of
The episode dives into Epic's recent rollout of twelve new FHIR APIs tailored for radiation oncology, highlighting how these modern interfaces support the CodeX Exchange of Radiotherapy Summaries Implementation Guide. It explains the distinct nature of radiation oncology—focused on precise...
Kansas City Launches Integrated Theranostics Platform Partnership
A public‑private partnership between the University of Kansas Health System, KU Medical Center, Children’s Mercy and Bold Advanced Medical Future (BAMF) Health is launching an integrated theranostics platform in Kansas City. The center will combine molecular imaging, radiopharmaceutical production, clinical...
Alliance of Companies Will Help Accelerate $50 Billion in Rural Health Programs
Science Applications International Corp. (SAIC) has launched the Alliance for Advancing Rural Healthcare (AARH), uniting seven partners—including Arcadia, Castlight Health, Covista, Mission Mobile Medical, Telemedicine.com, TruBridge and Walgreens—to execute the $50 billion Rural Health Transformation program. The alliance will bolster the...
AI Impact Summit: Meet ‘LuSI’, the ‘Made in India’ AI-Integrated Robotic Baby Revolutionising Medical Training
At the India AI Impact Summit 2026, Maverick Simulation Solutions unveiled LuSI, a 2.5 kg AI‑integrated robotic newborn that replicates real‑time respiratory conditions for high‑fidelity medical training, already adopted by AIIMS, AFMC and PGI. The same event highlighted PhonePe's launch of...
Athenahealth Launches Agentic Patient Comms Tools Across Provider Network
athenahealth unveiled the next generation of its AI‑native patient engagement suite within athenaOne, adding text and voice virtual assistants that let patients schedule appointments and ask routine questions 24/7. The texting feature is in alpha and will roll out broadly...
In the Clinic for Feb. 20, 2026
The February 20 2026 "In the Clinic" roundup aggregates a broad set of industry snapshots, special reports, and infographics covering biopharma, medical technology, and emerging research areas. It links to data on mRNA vaccine research, China’s GLP‑1 market, pulsed‑field ablation for atrial...
Money Raised by Biopharma
Recent biopharma research highlights IL‑22 and TL1A as a powerful biomarker pair for diagnosing hidradenitis suppurativa (HS), while TL1A overexpression is confirmed in patient lesions. Parallel studies reveal that inhibiting the NLRP3 inflammasome may mitigate vascular cognitive impairment and stroke‑related...
AI Tool Sets New Standard in Diagnosing Rare Diseases
A new multi‑agent system called DeepRare, built on the DeepSeek‑V3 large language model and over 40 specialized tools, outperformed 15 competing AI models and human physicians in diagnosing rare diseases. Across 6,401 cases covering 2,919 rare conditions, it achieved a...
Creatine: Unexpected Longevity Boost Beyond the Gym
Creatine: The Longevity Supplement Hiding in Plain Sight For decades, I dismissed creatine as a "gym bro" supplement. Bodybuilders. Pre-workout shakes. Bigger biceps. Not relevant to a physician focused on metabolic health and longevity. I was wrong. https://robertlufkinmd.substack.com/p/creatine-the-longevity-supplement?r=6er0b
Most Health Systems Stall Patients' HIPAA Record Rights
HIPAA guarantees patients a right to their own medical records. In practice, most health systems require patients to fill out a release-of-information form designed for a different legal purpose; justify why they want their own data; and wait. I sampled...
Single Yes-or-No Question May Screen for Low Vision
A study published in Investigative Ophthalmology & Visual Science shows that a single yes‑or‑no question can reliably screen for low vision and legal blindness, achieving area‑under‑the‑curve (AUC) values of 0.81 and 0.77 respectively. Researchers tested 385 adults across four U.S....
DOJ and Ohio AG Charge OhioHealth with Price‑Gouging, Anti‑Competition
DOJ, Ohio attorney general accuse OhioHealth of driving up prices, crowding out competition https://t.co/oxxD0glykV via @statnews
Health Leaders Need Operational Agentic AI Strategies
Health leaders: your AI strategy may exist… but is it operational? Here’s how organizations are actually deploying agentic AI: https://t.co/iAzZysMNQp Meet NTT DATA at #ViVE2026 🤝 @NTT_DATA_NA #AgenticAI #HITSM
Monocyte IL‑10 Explains Sex Differences in Pain Duration
Sex differences in pain duration Finding interleukin-10 from monocytes as an/the explanation (in the experimental model and people) @SciImmunology https://t.co/fOsciwav7Y
Smart, Narrow, Trusted AI: Prenosis Sepsis Test Approved
Healthcare AI doesn’t need to be louder. It needs to be smarter, narrower, and trusted. Prenosis’ FDA-authorized sepsis diagnostic shows what that looks like in practice. 🔗https://t.co/JQBRCOKfO3 @PrenosisInc #patientsafety #HITSM
Nasal Mucosa Targeted for Universal Respiratory Vaccine
How to get a universal vaccine vs respiratory threats? Block via the nasal mucosa @ScienceMagazine https://t.co/IjCkbF05LB @NatRevImmunol https://t.co/2W7SZ1fHSR https://t.co/XcEzcMeXrB
New Drug Discoveries Target Cancer and Autoimmunity
Discovering Drugs for Cancer and Autoimmunity. Listen to @Satpathology on The Long Run podcast. Sponsored by @AlphaSenseInc Dash Bio. https://t.co/02keVFdqzj
Madrigal Slides as Ex-Novartis Exec Joins Daiichi
Madrigal sees a stock sell-off; ex-Novartis exec heads to Daiichi https://t.co/ymSJ5qY8kq $MDGL $NVS $JNJ $ACIU #biotech