Mich. City Adds Fourth Ambulance, Fire Engine as City EMS System Expands
Flint, Michigan, has expanded its emergency services by adding a fourth ambulance and a $1.2 million fire engine to the city’s Fire Department fleet. The ambulance service, launched in 2024, has already completed more than 900 runs this year, and the new rig will allow a third ambulance to operate around the clock while keeping one unit in reserve. Funding for the ambulance came from $202,576 allocated from national opioid settlement dollars. Mayor Sheldon Neeley highlighted that the upgrades will improve response times and overall public safety.
FDA Town Hall: FDA’s Quality Management System Regulation (QMSR) – Medical Device Risk-Based Inspections
The FDA announced a town hall to discuss its updated Quality Management System Regulation (QMSR) that will govern medical device inspections beginning February 2, 2026. The new inspection framework replaces the long‑standing Quality System Inspection Technique (QSIT) and supersedes older...
Rare Disease Sales To Soar to $400B+ By 2032 as Small Molecules Resurgent: Evaluate
Orphan‑drug sales are projected to exceed $400 billion by 2032, more than double the 2025 level. Small‑molecule therapies dominate the pipeline, accounting for 45% of the 20 most valuable orphan candidates, signaling a resurgence after years of biologic focus. The Inflation...
Parkinson’s Research Reaches “Pivotal” Stage, but Barriers Remain
Parkinson’s research has entered a pivotal phase, driven by deeper disease insights and advanced models such as patient‑derived iPSCs. Despite a pipeline of potential disease‑modifying therapies, funding shortfalls and outdated trial endpoints continue to impede progress. Parkinson’s UK’s Virtual Biotech...
This Week in European MedTech and HealthTech: 13th March 2026
The European Commission is pushing a 2026 Health Package that revises the MDR/IVDR framework, introducing risk‑based certification, digital‑only declarations of conformity and tighter cybersecurity reporting. Parallel work on the AI Act will align high‑risk medical AI with the MDR/IVDR pathway,...
FDA Issues Final Guidance on Medical Devices with Indications Associated with Weight Loss
The U.S. Food and Drug Administration issued final guidance titled “Medical Devices with Indications Associated with Weight Loss – Premarket Considerations.” The document outlines recommended non‑clinical testing and clinical study designs for devices aimed at weight loss, obesity treatment, or...
Trump Policies Set to Increase Rates of Lung Disease and Death, Study Finds
A new study published in the American Journal of Respiratory and Critical Care Medicine finds that policies enacted during Donald Trump's second term are poised to dramatically increase lung disease incidence and premature deaths in the United States. The analysis...
The 510(k) Pathway in 2026: Navigating a Shifting Regulatory and Political Landscape for Medical Devices
The 510(k) premarket notification pathway continues to dominate U.S. medical device approvals, but recent data show escalating safety failures and a persistent “predicate creep” problem. In Q1 2026 the FDA introduced electronic eSTAR submissions and issued draft guidance on predicate selection,...
Immutep Investors Spooked by LAG-3 Failure in Lung Cancer
Australian biotech Immutep saw its ASX shares tumble more than 88% after the independent data monitoring committee recommended halting its pivotal phase‑3 TACTI‑004 trial of the LAG‑3 inhibitor eftilagimod alfa (efti) in first‑line non‑small cell lung cancer. The trial, which...
Otsuka Pharmaceutical Reports OLE Study Data on Repinatrabit in Phenylketonuria
Otsuka Pharmaceutical disclosed early open‑label extension (OLE) data for repinatrabit (JNT‑517) in adolescents with phenylketonuria (PKU). A 75 mg twice‑daily regimen achieved a 67% mean reduction in blood phenylalanine by day 56, with responses observed across prior sapropterin responders, non‑responders, and a...
Out of the Blue? How the Colour of Light Could Be Used to Treat Mental Illness
Researchers at St Olavs Hospital in Trondheim equipped one half of a psychiatric intensive‑care ward with blue‑depleted evening lighting while the other half kept standard lighting. In a randomized trial of 476 short‑stay patients, the circadian‑adapted ward showed greater clinical improvement...
Eliquis Proves Safer than Xarelto for Patients with Deep Blood Clots
A head‑to‑head trial published in the New England Journal of Medicine compared Eliquis (apixaban) and Xarelto (rivaroxaban) in patients with deep‑vein thrombosis. The study found Eliquis significantly reduced major bleeding risk while maintaining equal efficacy in preventing clot recurrence. This...
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HEALTH INEQUITY: Red Cross Children’s Hospital Doctor Using Donated ‘Miracle’ Cystic Fibrosis Drug to Save Lives
South Africa’s Red Cross Children’s Hospital is using donated Trikafta, a $300,000‑a‑year cystic fibrosis therapy, to keep seven‑year‑old Jaylin Leitjies alive after his lungs were severely damaged in infancy. The drug, produced by Vertex Pharmaceuticals, is not registered with SAHPRA...
Flagship Startup Loses CEO to Ipsen; Ionis to Shed Nearly Six Decades of Board Experience
Alltrna's CEO Michelle Werner announced her resignation, moving to pharmaceutical giant Ipsen as its new chief executive. The biotech startup will rely on interim management while it searches for a permanent replacement. Simultaneously, Ionis Therapeutics disclosed that several long‑standing board...
PE Delves Into Diverse Women’s Health Segments: 6 Deals
Private‑equity firms Ardian, Charterhouse, CVC and L Catterton led six recent transactions across the women’s health sector. The deals span fertility services, menopause therapeutics, breast‑cancer diagnostics, digital mental‑health platforms, and pelvic‑floor care. Collectively, the investments total roughly $1.2 billion, reflecting heightened...
Radiology Groups Push UnitedHealthcare and Cigna to Update Payment Policies for Key Service
Ten medical societies, including the American College of Radiology, have written to UnitedHealthcare and Cigna urging them to revise their coverage policies for peripheral nerve stimulation (PNS), a minimally invasive chronic pain treatment. The insurers currently classify PNS as experimental,...
Veterans Facing Significant Challenges Accessing Radiology Services, VA Watchdog Says
A VA Office of the Inspector General review found that 13 of 15 sampled radiology clinics lack essential call‑tracking data, rendering nearly 338,000 radiology‑related calls unmonitored. The missing data hampers the department’s ability to gauge response times, leading to delays...
This Little-Known Bioactive Helps Protect Against Dementia, Study Shows
A recent Neuroscience Insights review highlights citicoline, a CDP‑choline derivative, as a potent neuroprotective agent. Clinical data show consistent improvements in memory, concentration, and visual‑motor coordination for patients with mild cognitive impairment, especially of vascular origin. The bioactive also benefits...
Pharma’s Godfather Moment: Pulled Back Into Tariff Uncertainty
The U.S. Supreme Court nullified President Trump’s emergency authority to impose tariffs, reigniting uncertainty for the pharmaceutical sector. Despite the ruling, most‑favored‑nation (MFN) pricing agreements between branded drug makers and the Administration are expected to hold, though new U.S. manufacturing...
![[Obituary] Nicholas White](https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/18e02f397e47fea422ba4d31bfe3f731.webp)
[Obituary] Nicholas White
Professor Sir Nicholas White, a pioneering pharmacologist and tropical‑medicine clinician, led the development and global adoption of artemisinin‑based combination therapies (ACTs) that transformed malaria treatment. His early trials in the 1990s demonstrated ACTs’ safety and efficacy, prompting a WHO guideline...
![[Correspondence] Health in Africa: The WHO African Region in the Next Decade](https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/a9fe5635efddee78b24619bc1dc041d1.webp)
[Correspondence] Health in Africa: The WHO African Region in the Next Decade
In 2025 the WHO African region faced profound public‑health disruptions that accelerated a shift away from donor‑driven, disease‑specific programmes toward domestically financed, system‑wide strategies. Health is being repositioned as a macro‑economic asset, with preparedness, universal coverage and disease control framed...
![[Correspondence] National Lung Cancer Screening Programme in Brazil: An Urgent Need](https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/4fbfeafc7f96396bcc6e234922df9c92.webp)
[Correspondence] National Lung Cancer Screening Programme in Brazil: An Urgent Need
Lung cancer caused 44,213 new cases and 38,292 deaths in Brazil in 2022, imposing heavy morbidity and costs on the public health system. Unlike many nations, Brazil lacks a national low‑dose CT (LDCT) screening programme, despite strong trial evidence that...
![[Perspectives] Lessons From the History of the Uganda Virus Research Institute](https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/fa1fa72682f84e190ce5ce03ac058219.webp)
[Perspectives] Lessons From the History of the Uganda Virus Research Institute
During the 1960s, Uganda’s Virus Research Institute exemplified how African health research was rebuilt after independence, navigating the collapse of colonial institutions while maintaining productive collaborations. Today, abrupt reductions in U.S. development assistance—withdrawal from USAID, WHO, and Gavi—are destabilizing similar...
![[Comment] Moving Integrated Care Into the Community in Sub-Saharan Africa](https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/753ebea3da7faa88e67cea3df67e4d36.webp)
[Comment] Moving Integrated Care Into the Community in Sub-Saharan Africa
Vertical HIV programmes in East and Southern Africa have successfully expanded rapid treatment access, but rising non‑communicable disease (NCD) comorbidities among people living with HIV now demand integrated service delivery. Recent pragmatic trials such as INTE‑AFRICA (2023) and INTE‑COMM (2026)...
Why Revenue Performance Often Starts with Accurate Clinical Notes
Hospitals that prioritize accurate clinical notes see measurable revenue gains because documentation directly drives coding and reimbursement. Vague or incomplete entries cause denied claims, audit flags, and lost tariffs, even when billing tools are sophisticated. Solutions such as Scribe X and...
Listen: Could a Registry of Doctors Who Refuse Abortions Improve Access in Spain?
Spain's High Court of Justice ordered Madrid to immediately create a registry of doctors who conscientiously object to performing abortions. The national law, introduced in 2023, obliges all autonomous communities to maintain such lists to ensure women can access legal...
PsiQuantum and National Cancer Center Japan Partner on Quantum Computing
PsiQuantum and Japan’s National Cancer Center have signed a research agreement to explore utility‑scale quantum computing for oncology drug discovery. The collaboration will focus on developing fault‑tolerant quantum algorithms and deploying PsiQuantum’s Construct platform across the healthcare value chain. Additional...
PsiQuantum and National Cancer Center Japan Partner on Quantum Computing
PsiQuantum has signed a research agreement with Japan's National Cancer Center to explore utility‑scale quantum computing for oncology drug discovery. The partnership will focus on developing fault‑tolerant quantum algorithms and clinically relevant applications using PsiQuantum's Construct platform. It also brings...
National AI Strategy Launched in Ireland
Ireland has published its first national AI strategy for health, outlining a five‑year roadmap across four strategic pillars: clinical care, operations, research and innovation, and public health. The plan emphasizes AI‑driven improvements such as shorter waiting times, personalised treatment, diagnostic...
Sick Of Your CPAP Machine? Meet The Less Invasive Alternatives
Continuous positive airway pressure (CPAP) remains the clinical gold‑standard for obstructive sleep apnea, but adherence rates plummet as many patients find the mask noisy, uncomfortable, or claustrophobic. The article outlines a suite of less invasive alternatives—including daytime neuromuscular therapy, custom...
Pilatus Biosciences Doses First Patient in PLT012 Antibody Trial
Pilatus Biosciences has begun dosing the first patient in a Phase I, open‑label trial of PLT012, its first‑in‑class anti‑CD36 monoclonal antibody, at Next Oncology in Houston. The FDA recently issued IND clearance along with orphan‑drug status for hepatocellular carcinoma and fast‑track...
How Clinical Laboratories Can Prepare for Crisis Events Before They Happen
Clinical laboratories face unpredictable crises ranging from equipment failures to cyber attacks, demanding proactive resilience. Experts Tracy Durnan and Jason Nagy stress embedding preparedness into daily routines, from identifying cascade failures to regular infrastructure testing. Cross‑training, scenario‑based drills, and redundant...
Abbott Reports Positive FreeDM2 Study Results for CGM
Abbott announced that its FreeStyle Libre continuous glucose monitoring system outperformed traditional finger‑stick testing in the FreeDM2 randomised trial involving 303 UK patients with type 2 diabetes on basal insulin. After four months, CGM users achieved a larger reduction in HbA1c...
Where AI Agents Fit in Healthcare Operations
Avahi, an AWS Premier partner, is launching a free webinar on March 18 to demystify AI agents for healthcare executives. The session, titled “The AI Agent Implementation Framework,” will explain how AI agents operate within hospitals and identify high‑impact use...
Medicaid Can Share Data with ICE. Here's How that 180-Degree Change Spreads Fear
A December 2025 federal court ruling allows Medicaid to share enrollee names, addresses and immigration status with ICE, overturning long‑standing privacy assurances. The change, initiated by the Trump administration, removes the guarantee that health data would not be used for...
Families Scramble To Pay Five-Figure Bills as Clock Ticks on Promised Preauthorization Reforms
Patients like Sheldon Ekirch have spent nearly $90,000 fighting insurer denials for costly IVIG therapy, only to receive coverage after a Virginia external review overturned Anthem's decision. The case highlights ongoing frustrations with prior‑authorization processes despite industry pledges, made last...
STAT+: Trump Is Getting More Credit than Biden for Efforts to Lower Drug Prices
A recent KFF poll shows 41% of Americans believe the Trump administration’s policies will lower prescription drug costs, outpacing awareness of the Biden‑era Medicare price‑negotiation law. Support is sharply partisan—79% of Republicans versus 11% of Democrats share this view. Only...
Nevada Regulators Fine Peptide Providers at Anti-Aging Festival Where Two Women Became Critically Ill
Nevada regulators fined three individuals and a Texas private membership association for unlicensed peptide injections at the Revolution Against Aging and Death Festival, where two women became critically ill. The doctor and pharmacist each received $10,000 fines, the health coach...
PRISM BioLab and Receptor.AI Partner to Develop a Drug Discovery Platform
PRISM BioLab has teamed with Receptor.AI to build an AI‑driven, physics‑guided platform for discovering orally available small molecules that target intracellular protein‑protein interactions, membrane proteins, and complex receptor systems. The collaboration fuses PRISM’s PepMetics technology—3‑dimensional scaffolds that mimic α‑helix and...
CHMP Backs Expanded Indications for Uplizna in NMOSD, IgG4-RD and gMG
On 11 December 2025 the EMA’s CHMP issued a positive opinion to extend Uplizna’s (inebilizumab) marketing authorisation to three additional autoimmune conditions: neuromyelitis optica spectrum disorder (NMOSD), immunoglobulin G4‑related disease (IgG4‑RD) and generalized myasthenia gravis (gMG). The recommendation designates Uplizna as monotherapy for...
Natera Launches Zenith Genomics in the US to Diagnose Rare Diseases
Natera announced the commercial launch of Zenith Genomics, a next‑generation whole‑genome sequencing (WGS) assay aimed at diagnosing rare and ultra‑rare diseases in the United States. The platform pairs standard WGS with long‑read sequencing confirmation to capture complex genomic features such...
Woman with Rare Blood Feels 'Honoured' To Donate
Mina Stoddart‑Stones, a 26‑year‑old from Bridgwater, discovered she is one of only nine UK donors with the ultra‑rare U‑negative, N‑negative blood type. Her blood, also classified as the RO subtype, is kept in the NHS Blood and Transplant frozen bank...
RQM+ Launches SMART Solutions for MedTech Development
RQM+ announced SMART Solutions, a life‑cycle partnership model that fuses regulatory, quality, clinical, reimbursement and laboratory expertise for medical device and diagnostics firms. The offering comes in two formats: an integrated solution for small‑to‑mid‑size companies and a functional, modular option...
Get Adult Social Care Data Service Passes First Test
The Department of Health and Social Care’s Get Adult Social Care Data service has cleared its alpha assessment, meeting all 14 Government Digital Service standards. The platform consolidates data from multiple sources to aid local authorities, care providers, researchers, and...
IVF Not Linked to Overall Cancer Risk in Massive Study – but One Late-Life Danger Still Can't Be Ruled Out
Australian researchers analyzed nearly 418,000 women who underwent medically assisted reproduction between 1991 and 2018 and found no increase in overall invasive cancer rates compared with age‑matched peers. While overall risk was unchanged, specific cancers such as uterine, ovarian and...
BIG Summit Panel Breaks Down Risks and Opportunities Coming Out of DC
At the inaugural BIO BIG Summit, a Washington Policy Brief panel dissected the shifting U.S. healthcare landscape for biotech. The discussion highlighted progress on reauthorizing the Prescription Drug User Fee Act (PDUFA) and emerging pharmacy benefit manager (PBM) reforms, while...
Hospital Workers in Lebanon Speak About Their Grim Work
Hospital staff across Lebanon are confronting an escalating humanitarian crisis as daily death tolls climb amid ongoing Israeli bombardments. Emergency rooms are inundated with trauma patients while chronic shortages of medicines, oxygen, and power strain already fragile facilities. Workers describe...
Embedding Psychologists in Trauma Centres Improves Patient Outcomes
Embedding specialist psychologists within UK Major Trauma Centres has demonstrably improved patient outcomes, according to a qualitative evaluation of clinicians at Southmead Hospital. Front‑line staff reported higher patient engagement, faster rehabilitation, and better emotional adjustment when psychologists participated in ward...
AI Enabled Speech Therapy & Clinical Services Platform in Northern California
Prime exits® and American Healthcare Capital are marketing a fully integrated AI‑driven speech‑therapy platform in Northern California. The business combines a proprietary assessment and autism‑intervention suite funded by over $2.28 million in federal and corporate grants with a profitable clinical services...
Weight Watchers Releases GLP-1 Results Report Demonstrating 61% Greater Weight Loss
Weight Watchers unveiled a GLP-1 Results Report showing its integrated medical‑behavioral program drives 61.3% greater weight loss in the first month versus medication‑only users. Over 12 months, Med+ participants achieved a 21% average loss, maintaining 20.5% at 24 months. The...