Innovative Tech

MedTech Europe's Facts & Figures 2026 lands a split verdict on the European medtech industry 2026: record employment, near-record patent filings and a 77.4% EPO grant rate on one side; 1.8% market growth, a world market share down to 25.6% and the first fall in company numbers on the other. Digital reimbursement keeps expanding, led by Germany's 59 DiGA. #SyenzaNews #medtech #MarketAccess #digitalhealth

The CDRH FY 2027 guidance list is out. AI-enabled device software and change control plans top the A-list, 510(k) reform sits Under Construction, and comments close on November 30, 2026. #SyenzaNews #medicaldevices #FDA #MarketAccess

BD has agreed a $19 billion partnership with the US Government to expand American manufacturing of essential medical consumables. The deal includes $3 billion for production sites, roughly 5 billion more units a year and Section 232 tariff relief tied to milestones. #SyenzaNews #MedTech #MarketAccess

Lundbeck is trading scale for depth. Michala Fischer-Hansen, EVP for Europe and international markets, explains why 51 affiliates became 22, why a fifth of revenue now goes to R&D, and why US price pressure can decide where a medicine launches. #SyenzaNews #MarketAccess #brainhealth #pharma

Vaxcyte's VAX-31 met every prespecified primary endpoint in the OPUS-1 Phase 3 trial in adults, including superiority for the three serotypes unique to the vaccine. The 31-valent candidate now heads toward a BLA filing in 2028. #SyenzaNews #vaccines #pneumococcal #MarketAccess

FDA approval of the Autus Size-Adjustable Valve gives children with congenital pulmonary valve disease a pulmonary valve that can be widened as they grow, from 13 millimeters to 22 millimeters. The evidence base is 62 patients and six months of follow-up. #SyenzaNews #medicaldevices #pediatrics #MarketAccess

Zorginstituut Nederland has ruled that the Inreda AP stays out of the Dutch basic package. The DARE trial found no clinically relevant gain in glucose control or quality of life, serious adverse events were about three times more common, and half of the patients stopped using the device. #SyenzaNews #MedTech #MarketAccess #HealthEconomics

Eli Lilly and Company has set a parity target for its diabetes and obesity medicines: treat as many people in low- and middle-income countries as in high-income countries by 2040. The commitment carries no price mechanism, so progress will be judged against Lilly's own annual Sustainability Report. #SyenzaNews #globalhealth #pharmaceuticals #MarketAccess

Germany drug pricing policies are now the subject of a US Section 301 investigation. AbbVie's chief counsel, Perry Siatis, has filed written evidence and testified that government price setting, mandatory rebates and reimbursement restrictions undercut the incentives that fund new medicines. He also cites a German-French working group on keeping innovative medicines available. #SyenzaNews #MarketAccess #DrugPricing #HEOR

Mounjaro passed €1 million in pharmacy sales in a single day in Portugal, on more than 3,000 packs, and the Ordem dos Médicos has asked Infarmed for prescription data. Here is what the numbers show on access, reimbursement and supply. #SyenzaNews #GLP1 #MarketAccess

Syenza's webinar on AI governance in HTA drew 71% of participants who had not yet used AI in their work. The session covered the paper's governance checklist, the in-house Navigator tool, and a live rapid HTA of rituximab in lupus. #SyenzaNews #HTA #AIinHealth #MarketAccess

Nine pharma chairs, from AstraZeneca to Sanofi, warn Europe is losing the pharmaceutical investment race to the US and China, and call on governments to treat medicines as strategic infrastructure. #SyenzaNews #pharmaceuticals #MarketAccess #drugdevelopment