USA – We keep trying to make AI therapists. It’s not working.
We keep failing at making an artificial-intelligence Sigmund Freud, and there is both value and risk in leaning on technology to improve our mental...
Europe – MDCG 2022-17 – MDCG position paper on ‘hybrid audits’
This paper outlines the Medical Device Coordination Group (MDCG) position on the possible use of hybrid audits by notified bodies under Regulation (EU) 2017/745...
Europe – MedTech Europe’s vision for a resilient medical technology ecosystem
The digital ecosystem has dramatically changed the way in which healthcare is delivered to patients. Nowadays, medical technology companies concentrate not only on ensuring...
Europe – MDCG 2021-5 Rev. 1 : Guidance on standardisation for medical devices
The EU legislative framework on medical devices currently consists of two Regulations adopted and entered into force in 2017:
• Regulation (EU) 2017/745 on medical...
France – Plusieurs défis à relever pour assurer la sécurité des DM connectés (Afib)
LILLE (TICsanté) - Pour relever le défi de la sécurité des dispositifs médicaux (DM) connectés, il faut travailler sur la formation des ingénieurs biomédicaux,...
USA – FDA issues road map to medical device regulatory guidance topics list for...
The US Food and Drug Administration has released a list of guidance documents it plans to issue over its 2023 fiscal year. FDA’s Center...
USA – New FDA guidance offers ethical roadmap for including children in clinical trials
The US Food and Drug Administration (FDA) has issued draft guidance outlining a series of ethical considerations for conducting clinical trials that involve children.
The guidance,...
UK – Artificial pancreas technology set to change lives
Individuals who are typically unable to manage their type 1 diabetes will be offered new technology to help them control their condition. Furthermore, the...
France – Ensinger Machining utilise hyperMILL pour usiner le cœur artificiel Carmat
Basée à Beynost dans l'Ain, Ensinger Machining (anciennement UMP) est spécialisé dans l'usinage de matières plastiques hautes performances. Filiale française du groupe allemand Ensinger,...
Europe – Le règlement (UE) 2023/607
Le règlement (UE) 2023/607, publié au JOUE, modifie les dispositions transitoires relatives à certains dispositifs médicaux et à certains dispositifs médicaux de diagnostic in...
