Innovative Tech

The FDA has granted accelerated approval to Voceryq, the first plasmid DNA-based immunotherapy in the US, for adults with recurrent respiratory papillomatosis.

MIT's William Bonvillian opens his innovation systems course with Solow and Romer: technology drives about two-thirds of US growth, and R&D only pays off with trained talent doing it. His prospector theory has a blunt corollary for anyone fencing off talent. #SyenzaNews #InnovationPolicy #HealthEconomics #RandD

Four authors writing in The Lancet Regional Health - Europe say the Commission's MDR and IVDR simplification proposal keeps the core flaw: notified bodies still decide, one by one, whether innovative devices reach the market. They argue for an EU medical device agency with binding powers over strategy, guidance and advice. #SyenzaNews #MedTech #MedicalDevices #MarketAccess

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The FDA's draft guidance lets sponsors add new patient-specific variants to one BLA without new trials, while CMS plans to broaden its gene therapy access model.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