NICE Issues Two Major 2025 Approvals: Vutrisiran for ATTR-CM and Aucatzyl CAR-T for R/R B-ALL
NICE has issued two major decisions: recommending vutrisiran for adult ATTR-CM and approving Aucatzyl CAR-T for relapsed or refractory B-ALL in adults.
Industry Trends
CMS Sets New Medicare 2026 Rates Across Five Innovation Categories
What the New Medicare 2026 Rates Mean for Access and Adoption The U.S. Centers for Medicare & Medicaid Services (CMS) has delivered a rare cluster of reimbursement decisions that collectively mark one of the most significant access-defining weeks of 2025. Spanning neuromodulation, molecular diagnostics, AI imaging, autoimmune disease therapy, and oncology support care, the rulings … Read more
NICE Recommends Nanox.AI’s Spine-Fracture Detection Tools for Early Value Assessment Across NHS Hospitals
NICE has recommended Nanox.AI’s HealthOST and HealthVCF for Early Value Assessment, enabling NHS hospitals to deploy the AI tools for three years while gathering evidence on their value in detecting vertebral fragility fractures. The decision marks an important step in advancing AI-driven early detection of osteoporosis.
CMS Finalizes SAINT Payment Stability and Major Reimbursement Gains for NeuroPace’s RNS System
CMS has finalized two separate 2026 rulings benefiting neuromodulation innovators: stable outpatient reimbursement for Magnus Medical’s SAINT therapy and significant payment increases for NeuroPace’s RNS System across physician and hospital settings. The updates strengthen patient access and support broader adoption of advanced brain-health technologies.
GE HealthCare to Acquire Intelerad for $2.3B to Build a Cloud-First Enterprise Imaging Platform
GE HealthCare to Acquire Intelerad for $2.3B, Advancing a Cloud-First Imaging Strategy and Expanding Its Reach Across Ambulatory and Hospital Markets GE HealthCare has signed an agreement to acquire Intelerad for $2.3 billion in cash, a move that significantly accelerates the company’s cloud-first transformation and strengthens its position across enterprise imaging in both hospital and … Read more
ConcertAI’s TeraRecon Launches DETECT to Align AI Imaging With Reimbursement and Clinical Workflow
ConcertAI’s TeraRecon division has launched DETECT, an AI-first platform designed to close the gap between imaging innovation and reimbursement.
Germany Updates Emergency-Care Tiers as IQWiG Questions Daratumumab Benefit in Smoldering Myeloma
Germany issued two significant regulatory updates: the G-BA expanded its emergency-care tier system by adding a new “non-participation” level, and IQWiG reported that daratumumab shows no proven survival benefit in smoldering multiple myeloma due to flaws in the comparator arm of the AQUILA study.
CMS Sets National Pricing for Vesiflo’s inFlow Device, Expanding Access for Women With Permanent Urinary Retention
CMS has set national pricing for the inFlow Voiding Prosthesis in the 2026 Medicare fee schedule, expanding access to the only alternative to lifelong catheter use for women with permanent urinary retention.
NICE Issues New Updates on AI Cancer Detection, Sepsis Care, and Breast Cancer Drug Appraisal
NICE has published three updates spanning diagnostics, acute care, and oncology: conditional support for AI tools that detect bowel cancer polyps, new sepsis guidelines emphasizing tailored treatment, and the termination of a trastuzumab deruxtecan appraisal after no company evidence submission.
Valo Health, Merck KGaA Launch $3B+ AI Collaboration Targeting Parkinson’s Disease
Valo Health has entered a collaboration with Merck KGaA, Darmstadt, Germany worth over $3 billion to accelerate AI-driven discovery of Parkinson’s disease therapies.