Innovative Tech

The EMA orphan medical devices pilot ran from August 2024 to March 2026. All 13 finalised procedures gave positive orphan status advice, and the service is now established. #SyenzaNews #MedTech #MarketAccess

EMA's expert panel advice pilot for high-risk medical devices closed in February 2026 with 27 advice procedures finalised. Average advice time fell from 112 days in phase one to 86 in phase two, and a 60-day procedure followed. #SyenzaNews #MedicalDevices #HTA #MarketAccess

The FDA's draft guidance lets sponsors add new patient-specific variants to one BLA without new trials, while CMS plans to broaden its gene therapy access model.

A new npj Digital Medicine article in press from SCPMG proposes the C-TACT clinical AI governance framework, with weighted lifecycle scorecards and its limits stated.

Regulators at the HMA-EMA AI group on 5 October 2026 outlined AI guidance in clinical development, with a concept paper and public consultation to follow.

EMA has updated its business process for expert panel consultations on high-risk medical devices. The revision, effective 12 October 2026, adds orphan device advice as a new sub-process. #SyenzaNews #MedicalDevices #MarketAccess #HTA

Insulin analogue cost-effectiveness studies for adults with type 1 diabetes mostly point the same way: the newer products usually come out ahead of human insulin. A new systematic review says that headline rests on thinner ground than it looks. The paper, by Shiwa Yaghoubi Bina, Steve Njokuocha and the T1D Economic Evidence Synthesis Group, has been accepted for Value in Health. The version available now is a pre-proof, so figures could still change at copyediting. The World Health Organization funded […]

OHE's A Dose of Economics explores why medicines made for one patient challenge regulation, payment and HTA.

AI is entering every stage of medical training. A new npj Digital Medicine Perspective maps how to integrate it responsibly across UGME, GME and CME.

Halozyme has won a Keytruda SC injunction in the Netherlands, ordering MSD to stop supplying the subcutaneous form of pembrolizumab in eight European markets. The case turned on how the patent's stability test is measured, and the injunction lapses country by country if a national court invalidates its part of EP 2 797 622. #SyenzaNews #oncology #patentlitigation #MarketAccess

A new European Observatory toolkit says biosimilar uptake policies only work as a mix. Denmark pushed adalimumab biosimilars past 90%, Ireland shared €10 million of savings with clinical teams, and Finland cut reimbursement spending by €42 million. #SyenzaNews #Biosimilars #MarketAccess #HealthPolicy

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