From the President’s Desk
In his February 2026 presidential column, Dr. Qihui‑Jim Zhai urges the pathology community to embrace digital pathology and AI tools rather than wait for perfect solutions. He argues that resistance risks being left behind as laboratories worldwide adopt these technologies to boost efficiency and patient care. The College of American Pathologists (CAP) offers guides, webinars, and networking opportunities to help pathologists evaluate and implement new tools. Zhai challenges each lab to identify a technology that fits its workflow and patient population.
TAVR Linked to Higher Reintervention Rate than SAVR in Evolut Low Risk Trial Update
A six‑year update of the Medtronic‑funded Evolut Low Risk trial shows that transcatheter aortic valve replacement (TAVR) with a self‑expanding valve has a higher reintervention rate than surgical aortic valve replacement (SAVR) in low‑risk patients—5.5% versus 3.3% at six years,...
Completed BsUFA II Deliverables
The FDA has completed the BsUFA II deliverables, publishing a final assessment of the Biosimilar User Fee Act review program on February 21, 2022 and an interim assessment on January 27, 2021. Alongside these reports, the agency released annual updates...
Mass General Brigham Evaluates Emerging Healthcare Technologies
Mass General Brigham is actively scouting emerging health technologies, with AI‑assisted robotics at the forefront. The system envisions robots handling specimen transport, medication delivery, and post‑operative equipment sterilization to ease staff workload and reduce sharps injuries. A limited COVID‑era pilot...
HIMSS26: Former AMA President Dr. Jesse Ehrenfeld Gives Keynote to Kick Off Physicians’ Forum
Dr. Jesse M. Ehrenfeld, former AMA president and global CMO of Aidoc, opened HIMSS26’s Physicians’ Forum with a keynote titled “From Hype to Healing: Real‑World AI Integration in Clinical Practice.” He warned that clinicians are overwhelmed and that AI must...
Alan Launches Alan Clinic in Canada: Bringing Mental Health Care Directly Into the Insurance App
Alan has launched Alan Clinic, an in‑app mental health support service for its Ontario members, embedding licensed talk therapy directly into its digital insurance platform. The offering provides secure video sessions, scheduling, and payment within a single app, bypassing public...
Medtronic Completes First Hugo Case in the US
Medtronic performed the first U.S. Hugo robotic surgery—a prostatectomy at the Cleveland Clinic—shortly after receiving FDA clearance. The system, already CE‑marked in Europe, is being installed at Duke University Hospital and Atrium Health, marking its initial U.S. footprint. CEO Geoff...
More Shots on Goal: Boehringer’s Long-View Playbook From IPF to Obesity
Boehringer Ingelheim is expanding its cardio‑renal‑metabolic (CRM) platform beyond its recent idiopathic pulmonary fibrosis (IPF) successes to target obesity and related metabolic disorders. President Brian Hilberdink says the company is prioritizing partnerships rather than large‑scale M&A to broaden its pipeline...
How CathWorks Leaned on Its Partner Medtronic to Succeed
CathWorks, an AI‑driven startup that creates non‑invasive FFR assessments from routine angiograms, survived the pandemic by leaning on Medtronic’s early minority investment and strategic guidance. After automating its 3‑D coronary modeling to cut analysis time from 22 minutes to two,...
FDA Clears 12-Lead, Cable-Free Home ECG Monitoring System
The FDA granted 510(k) clearance for HeartBeam’s cable‑free 12‑lead ECG synthesis software, allowing home‑based arrhythmia assessment. The system captures cardiac signals in three non‑coplanar dimensions and reconstructs a full 12‑lead trace that can be reviewed by board‑certified cardiologists on demand....
First Ever The Surgeon Show to Take Place in London This Week
The Surgeon Show 2026, the first UK‑focused surgical summit, convenes on 20 February at London’s Minster Building. Invitation‑only, it gathers over 60 leading surgeons, clinicians, policymakers and technology innovators from more than 50 health organisations. The one‑day event, backed by...
Telehealth for Primary Care Levels Off: Epic
Epic’s analysis of 411 million primary‑care visits shows telehealth usage has plateaued at roughly 6‑7 % of appointments since mid‑2023, following the pandemic‑driven surge. The share remains highest in metropolitan areas, with lower adoption in micropolitan, rural and small‑town settings. Adults aged...
Fitch Downgrades Missouri Hospital to ‘D’ Rating
Fitch downgraded John Fitzgibbon Memorial Hospital in Marshall, Missouri to a “D” rating from “C” and withdrew its issuer and bond ratings after the hospital defaulted on required debt payments. The default concerns principal and interest on 2010 bonds, and...
Marshfield Clinic to Open 13th Hospital March 1
Marshfield Clinic will open its 13th hospital on March 1 in Wisconsin Rapids, adding a full‑service acute‑care facility to the existing Marshfield Clinic Wisconsin Rapids Center. The new campus features inpatient beds, an emergency department, advanced imaging such as CT...
Regulatory Innovation as a Catalyst: How New Compliance Strategies Are Speeding Up Healthcare Technology Adoption
Regulatory bodies are reshaping medical‑device oversight to prioritize usability, interoperability, and cybersecurity, accelerating adoption in both hospitals and homes. New human‑factors guidelines, AI/ML lifecycle controls, and post‑market surveillance tools ensure devices are safe, intuitive, and adaptable to real‑world conditions. Manufacturers...
Amwell Expects Lower Revenue in 2026
Amwell announced 2026 revenue guidance of $195 million to $205 million, down from $249.3 million in 2025, after divesting non‑core assets. The company has consolidated its offerings into a single, technology‑enabled care platform focused on SaaS and third‑party services. Executives said the streamlined...
The “Silent” Risk in the NICU: Why Your EHR Can’t Protect Infant Feeding
Feeding in neonatal intensive care units is a high‑risk, high‑frequency workflow that many hospitals still manage with paper logs and manual checks because commercial EHRs were not built for end‑to‑end feeding control. The article highlights how gaps in verification—especially before...
Cleveland Clinic 1st to Use New Robot for Prostate Surgery
Cleveland Clinic became the first U.S. health system to perform a robotic‑assisted prostatectomy using the newly FDA‑cleared Hugo RAS system. The robot, approved in December, features modular arms and an open‑console that surgeons control with foot pedals and hand inputs....
Fraud In The Care Economy Morphs From Solo Scams To Global Syndicates
The care economy’s expansion has attracted a sophisticated, global fraud network that stole nearly $4.9 billion from older Americans in 2024, a three‑fold rise over five years. Scammers now run multi‑stage attacks that blend tech‑support ruses, fake bank officials, and crypto...
Building on a Foundation of Culture and Trust: How Jefferson Health Reopened a Hospital Just 9 Days After a Fire
On Feb. 4, a fire engulfed the Orthopedic Institute building at Jefferson Health’s Lehigh Valley Hospital‑Dickson City, prompting the evacuation of more than 70 patients. Thanks to extensive disaster training and coordinated effort among staff, first responders, and local partners, no...
GE HealthCare Expands $35M BARDA Contract to Develop AI-Powered Trauma Ultrasound
GE HealthCare has secured a $35 million expansion of its BARDA contract to accelerate AI‑powered ultrasound development for trauma care. The funding will support both hardware and software to create point‑of‑care devices that automatically detect lung collapse and intra‑abdominal bleeding. The...
Jefferson Posts $201M Operating Loss in H1
Thomas Jefferson University, owner of Jefferson Health, posted a $201 million operating loss for the first half of fiscal 2026, reflecting a -2.3% operating margin. The loss includes $64.7 million in restructuring expenses tied to a planned layoff of roughly 650 employees....
The Great Opt-Out: Why Patients Are Ditching Insurance for Cash-Pay Digital Care
Vanessa Slowey, CEO of TelyRx, highlights a growing shift as millions of Americans, burdened by rising premiums, limited ACA subsidies and fragile telehealth policies, are opting for cash‑pay digital care. Uninsured rates sit at 27 million, and roughly one‑quarter of insured...
Nearly 90% of the Largest U.S. Healthcare Systems Use UKG
UKG announced its presence at ViVE 2026 and HIMSS 2026, showcasing its Workforce Operating Platform tailored for healthcare. The platform, already used by nearly 90% of the largest U.S. health systems, combines HR, payroll and AI‑driven workforce management to boost productivity and...
Cosmetic Manufacturers Pty Ltd. - 719225 - 02/06/2026
The U.S. Food and Drug Administration issued Warning Letter 320‑26‑43 to Cosmetic Manufacturers Pty Ltd., citing extensive Current Good Manufacturing Practice (CGMP) violations across laboratory testing, process control, equipment qualification, and written procedures. The agency placed the firm on Import...
Edwards Sued In Chancery Over $300M Heart Valve Earn-Out
Former shareholders of Valtech Cardio have sued its parent, Edwards Lifesciences, in the Delaware Chancery Court, alleging the medical‑device giant deliberately stalled development of a heart‑valve repair system. The lawsuit claims Edwards is avoiding payment of up to $300 million in...
McLaren Health Care Partners with Bunkerhill Health for AI-Powered Cardiovascular Screening
McLaren Health Care has launched Michigan’s first AI‑driven cardiovascular screening program in partnership with Bunkerhill Health. The initiative uses Bunkerhill’s Carebricks platform to analyze routine chest CT scans for incidental coronary artery calcium and aortic valve calcium, biomarkers of heart...
Piloting New Technology with a Structured Approach
Mass General Brigham’s chief digital officer, Esther Kim, outlined a disciplined pilot framework for emerging health technologies. The process begins with rigorous vetting to ensure alignment with the system’s strategic priorities. Pilot projects are measured against predefined clinical, operational, and...
Does Vaxart Hold the Key to the Elusive Norovirus Vaccine?
Vaxart is advancing an oral, bivalent norovirus vaccine pill (VXA‑G1.1‑NN) that demonstrated a 30% reduction in infection in a Phase 2b challenge study. The vaccine uses a non‑replicating adenovirus vector loaded with a dsRNA adjuvant to stimulate gut immunity, and a...
Prima Mente Unlocks Early-Stage Alzheimer’s Diagnostics with Epigenome Model
AI biology firm Prima Mente has launched Pleiades, a 7‑billion‑parameter epigenetic foundation model that reads DNA methylation in cell‑free DNA to diagnose early‑stage Alzheimer’s and Parkinson’s. In real‑world cohorts the model achieved 89% detection accuracy, rising to 97% when combined...
This Startup Developed a First-of-Its-Kind Brain Function Assessment Device
QuantalX secured FDA de novo clearance for Delphi‑MD, a first‑of‑its‑kind device that fuses transcranial magnetic stimulation (TMS) with electroencephalography (EEG) to deliver real‑time brain network function assessments. The system leverages proprietary algorithms and an age‑correlated normative database to generate actionable...
Tolion Health AI Forms Scientific Advisory Board with Leading Experts in Alzheimer’s, Brain Health, and Artificial Intelligence
Tolion Health AI announced the creation of a Scientific Advisory Board composed of leading neuroscientists, Alzheimer’s researchers, and AI experts to steer its clinical validation and research strategy. The board follows the launch of Tolion Brain Coach, a free AI‑powered...
Can Treg Cell Therapy Really Target Autoimmunity?
Regulatory T‑cell (Treg) therapies are moving from discovery to clinic, with multiple biotech firms reporting early clinical data. Sonoma Biotherapeutics’ CAR‑Treg candidate SBT‑77‑7101 achieved a 67% reduction in rheumatoid‑arthritis swelling in a Phase 1 trial, while Coya Therapeutics secured IND approval...
SpendRule Launches AI-Powered Contract Intelligence Platform with OSF HealthCare and MemorialCare
SpendRule has launched an AI‑driven contract intelligence platform that adds a fourth validation layer—contract terms—to traditional three‑way matching in hospital accounts payable. The solution targets the $323 billion purchased‑services spend category, where industry analysts estimate $32 billion in preventable overpayments each year....
Daffodil Health Raises $16.3M for AI Claims Automation
Daffodil Health announced a $16.3 million Series A round, bringing its total capital to $20.9 million. The San Francisco startup uses AI and large‑language models to automate health‑plan administration, focusing on out‑of‑network pricing and payment‑integrity workflows. Funds will accelerate product development and expand...
Function Health’s New Erewhon Smoothie Was Designed to Highlight Nutritional Gaps and Promote Telehealth Lab Testing
Function Health, a telehealth platform with half‑million users, unveiled a limited‑edition Erewhon smoothie to spotlight widespread nutritional deficiencies revealed by its lab tests. The company reports that 65% of members have elevated insulin, 54% show high ApoB, and 70% are...
Competitive Generic Therapy Approvals
The FDA’s Office of Generic Drugs has launched a public, bi‑weekly list of all approved abbreviated new drug applications (ANDAs) that carry a Competitive Generic Therapy (CGT) designation. The list details each product’s reference listed drug, NDA number, applicant, active...
International News in Brief: Bill Passed on Sharing of Health Information in Singapore; National EHR in Guyana, Spain to Improve...
Singapore passed a Health Information Bill requiring all licensed providers to share key patient data via a national EHR, with cybersecurity safeguards and a 2027 rollout. Guyana launched a national EHR that includes online appointments and imposes hefty fines for...
Lung Cancer Rising Among Never-Smokers. Screening For This Group Lags.
Never‑smokers now account for 10‑20% of U.S. lung‑cancer cases, a share that is climbing despite overall declines. Current USPSTF guidelines limit low‑dose CT screening to heavy‑smoking adults, leaving most never‑smokers unscreened. Shira Boehler’s incidental finding on a whole‑body MRI prompted...
As FDA Moves Away From Animal Testing, AI and Organoids Can Shine
The FDA is actively phasing out animal‑testing requirements for certain therapies, a move echoed by the NIH and codified in the pending FDA Modernization Act. This regulatory shift opens the door for artificial intelligence and human‑derived organoid models to become...
How Treasure Health Is Pursuing ‘People-Centered Innovation’
Treasure Health, a Florida hospice provider, has added its first chief operating officer, Shannon Cooper, and appointed Jennifer Creel as chief clinical officer to spearhead a people‑centered innovation agenda. The leadership duo will focus on compliance, workforce support, and mission‑aligned...
Autism In Women May Be As Common As In Men, Study Finds
A large Swedish cohort study of 2.7 million children tracked over 35 years shows that while boys are diagnosed more often in childhood, the male‑to‑female autism ratio narrows to about 1.2 by age 20 and may reach parity in adulthood. The...
Half of Americans Believe only the Rich Can Afford GLP-1s without Insurance
A ValuePenguin study finds that a median‑income American household would need to allocate about 7.3% of earnings to afford a two‑milligram monthly supply of Ozempic, the flagship GLP‑1 weight‑loss drug. In the poorest states, the cost can approach one‑tenth of...
Dual Wielding in I&I: A Pivotal Year Ahead
The article argues that the next breakthrough in immunology and inflammation (I&I) therapeutics will come from multi‑drug and multi‑target strategies rather than single‑target antibodies, which have hit an efficacy ceiling. It traces the evolution from early blockbuster biologics like Humira...
IT Execs Seek to Tame Application Sprawl Without Stifling Innovation Through Shared Governance
In a healthsystemCIO webinar, senior IT leaders from RWJBarnabas Health, Ardent Health Services, and the University of Maryland Medical System discussed how to manage the flood of application requests while fostering innovation. They emphasized establishing a single, standardized intake point,...
STAT+: Ocular’s Experimental Eye Drug Beats Low Dose of Regeneron’s Eylea in Late-Stage Trial
Ocular Therapeutix announced that its experimental drug Axpaxli met the primary endpoint in a Phase 3 trial for wet age‑related macular degeneration, maintaining vision in 74% of patients at nine months and 66% at one year after a single injection....
Size‐Transformable Supramolecular Nanoprodrugs Enable Redox Imbalance Amplification and Cholesterol Modulation to Boost Multidimensional Tumor Immunotherapy
Researchers have engineered a tumor‑targeting, tumor‑microenvironment‑responsive supramolecular nanoprodrug that switches size to enhance deep tumor penetration. The nanoprodrug simultaneously induces redox imbalance—accumulating reactive nitrogen species and depleting glutathione—to amplify ferroptosis, while depleting cholesterol to rejuvenate exhausted T cells. This multidimensional...
PH‐Responsive Nanoparticle‐Coated Calcium Phosphate Granules for Bone Cancer Therapy
Researchers have engineered β‑tricalcium phosphate (β‑TCP) granules coated with selenium‑doped mesoporous silica nanoparticles (SeMIA) linked via pH‑responsive imine–alendronate bonds. The imine linkers remain stable at physiological pH but cleave in the mildly acidic osteosarcoma microenvironment, releasing nanoparticles that selectively kill...
Suspendable and Scalable Ultrasound‐Actuated ZnO‐Nanosheet‐Based Piezoelectric Microdevices for Wireless Electrical Stimulation of Cells
Researchers have created subcellular-sized, silicon‑based microdevices that incorporate ZnO nanosheets to act as piezoelectric generators. When deformed by cellular forces or external ultrasound within the biomedical range, these nanostructures produce localized electrical potentials that depolarize cell membranes and trigger calcium...
STAT+: Compass Says Its Psilocybin Drug Helped Patients with Severe Depression in Two Trials
Compass Pathways announced that its synthetic psilocybin therapy, COMP360, achieved statistically significant improvements in two identical Phase 3 trials for severe major depressive disorder. Both studies met primary endpoints, showing greater reduction in depression scores than placebo‑controlled psychotherapy. The data suggest...