The Data Act puts device data in the hands of hospitals

SAHPRA has opened Phase 2 of its medical device registration feasibility study, with expressions of interest due by 16:30 on Friday 18 September 2026. The test is voluntary and unpaid, but it is a rare chance to shape how South Africa registers devices before the process becomes mandatory. #SAHPRA #MedicalDevices #RegulatoryAffairs #MarketAccess

South Africa’s High Court has kept the semaglutide compounding ban in place, dismissing iDexis’s appeal as an ‘abuse of process’ while SAHPRA and SAPC finish their investigations. #SyenzaNews #MarketAccess #Pharma

A new open-source framework splits medical exam-item writing across specialist AI agents. In a blinded evaluation, multi-agent output won 57.7% of expert preferences against 42.3% for a single model. #SyenzaNews #DigitalHealth #AIinHealthcare

Enhertu’s DESTINY-Lung04 trial cut the risk of progression versus chemo-immunotherapy in first-line HER2-mutant NSCLC, but an immature overall-survival trend and a 20.8% ILD rate complicate the path to a first-line label. #SyenzaNews #Oncology #NSCLC #MarketAccess

Every NCCN academic cancer center now reports a shortage of at least one anticancer medicine, led by ifosfamide (94%) and carboplatin (71%). Pharmacy directors say three years of policy have not moved the problem. #SyenzaNews #DrugShortages #Oncology #MarketAccess

NICE has opened consultation on draft guidance that does not recommend lenacapavir for HIV PrEP, finding the six-monthly injection is not value for money for the NHS in England. #SyenzaNews #HTA #HIV #PrEP #MarketAccess

Alec Morton of NUS explains how AI is changing health technology assessment, what stays human, and why cheaper analysis could mean more health economics.

The European Commission’s EU Public Procurement Act would make quality, not price, the default for public tenders. EFPIA supports the shift, with one warning: resilience should not become local-content rules. #SyenzaNews #EUProcurement #Medicines #MarketAccess #HealthPolicy

An independent UK commission has published its recommendations for regulating AI in healthcare. The report calls for staged approvals and continuous real-world monitoring, alongside stronger enforcement powers for the MHRA. #SyenzaNews #AI #Healthcare #MarketAccess

Nova SBE’s Saúde em Perspetiva podcast asks what Portugal’s National Health Service should want from AI, and where the red lines sit. #SyenzaNews #DigitalHealth #AIinHealthcare