What's happening: FDA places Regeneron's anti‑activin A antibody garetosmab under priority review
The FDA has granted priority review to Regeneron's garetosmab for the rare disease fibrodysplasia ossificans progressiva, with a decision expected by August. Phase 3 OPTIMA results showed a 94% reduction in new heterotopic ossification lesions at the lower dose and a 90% reduction at the higher dose, alongside a >99% drop in lesion volume.
Also developing:

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, the company secured FDA, EU and Japan clearances and completed five global validation studies. Medtronic announced a deal to acquire CathWorks for up to $585 million, aiming to embed the technology in its cath‑lab portfolio. The acquisition comes as CathWorks prepares to present a 1,900‑patient randomized trial at the ACC meeting.
The next decade is the brain health decade, as I discussed with Bristol Myers Squibb (@bmsnews) CEO Chris Boerner at their Global Town Hall last week when @Thrive Global launched our brain health partnership to their 34,000 employees. BMS is...

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....

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...

The episode breaks down the Department of Labor's newly announced $145 million Pay‑for‑Performance Incentive Payments Program, aimed at alleviating the looming 3.2 million‑worker shortage in U.S. healthcare. It explains why the program’s performance‑based funding model—paying per enrolled apprentice rather than upfront grants—creates...

The episode examines UnitedHealthcare's new policy requiring primary‑care referrals for specialist visits in its Medicare Advantage HMO and HMO‑POS plans, a change that will fully take effect after April 30. Through the stories of seniors like Theresa Schwartz and Pamela...

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 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 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 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 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...

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 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....

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...

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 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...

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....
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...

In this episode, Dr. Ben Schwartz critiques the CMS ACCESS model and other value‑based care frameworks for their overwhelming administrative complexity and limited impact. He proposes a "Simple Model"—a streamlined fee‑for‑service system with minimal metrics, no prior authorizations, and higher...

BIOTRONIK has introduced the Acticor Sky and Rivacor Sky family, the world’s first CE‑approved high‑voltage devices capable of left bundle branch area pacing (LBBAP). The inaugural European implant was performed at University Hospital Frankfurt in an 87‑year‑old with ischemic cardiomyopathy and atrial...

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...

Patchwork Health has launched an AI‑driven Preference‑Based Rostering tool for NHS Trusts, instantly converting clinicians' shift preferences and service demand into compliant, fair schedules. The platform claims to meet 98% of negative preferences, cut unfilled shifts by 97% and slash...

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...

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 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...
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...

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...

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...

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...

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...

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....

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...

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...

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...

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...

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...

Are people actually aging slower today? Or are we just cherry picking the data? We are in the beginning of a longevity revolution.

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...

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...

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...

Tanaka Precious Metal Technologies has built a total‑solution system for contract manufacturing of in‑vitro diagnostic test kits, adding dedicated dispensing and packaging lines for extraction buffer. The new infrastructure lets the company handle every step—from assay development to final product...
https://open.substack.com/pub/pauloffit/p/weaponizing-the-fda-against-vaccines?utm_campaign=post-expanded-share&utm_medium=web A closer look at the FDA's recent kill shot against an mRNA influenza vaccine.

Dr. Ronald L. Lindsay recounts how he built a fully operational pediatric medical home at a regional military hospital in just two and a half years, delivering 24/7 care to vulnerable children from worldwide military families. His interdisciplinary developmental‑behavioral clinic...
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...
Dave Newman, MD, Chief Medical Officer of Virtual Care at Sanford Health, explains how the system’s expansive virtual care program—spanning 78 specialties across 300,000 square miles—has become essential for rural patients, saving them an average of 176 miles per visit....
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,...

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....

I interviewed a dual-boarded psychiatrist and internist who warns that the ambiguity of CPT codes is being used to criminalize physicians. Dr. Muhamad Aly Rifai joined me to discuss the chilling case of Dr. Ron Elfenbein. During the COVID-19 pandemic, Dr. Elfenbein...

A short thread on GLP-1s based on new publications. 1. The safety story Table of potential side effects and very good description of mechanisms, especially w/r to retina https://t.co/L5GNZyArrn https://t.co/MyXVOF3SYv
"Dual Wielding in I&I: A Pivotal Year Ahead" - new blog - Atlas EIR Cody Tranbarger with a tour de force on the bispecific opportunities in autoimmune... https://t.co/StQJX0vgfx