USA – Quinze ans de prison requis contre Elizabeth Holmes, fondatrice de Theranos
Les procureurs ont requis 15 ans de prison contre Elizabeth Holmes, star déchue de la Silicon Valley, tandis que la défense a plaidé pour une...
Europe – Nanoparticle-based drug delivery systems
EVO-NANO aims to create an integrated cross-disciplinary platform for the artificial evolution and assessment of nanoparticle-based drug delivery systems. Nanoparticles (NP) are increasingly being...
USA – Action needed on FDA regulation of AI-based medical devices
After lagging other sectors for years, the era of artificial intelligence (AI) in healthcare is dawning as its use is becoming more prevalent in a variety...
USA – FDA advisors want standards, labeling to address racial disparities with pulse oximeters
A panel of external US Food and Drug Administration (FDA) experts are urging more research to improve the efficacy of pulse oximeters in people...
France – La Société française de dermatologie appelle les autorités à réglementer l’usage de...
PARIS (TICpharma) - La Société française de dermatologie (SFD) et son groupe de télédermatologie et e-santé (Teldes) a appelé les autorités de santé à...
France – Surveillance des infections associées aux dispositifs invasifs en 2020
Santé publique France publie les résultats de la 2e édition de la mission nationale SPIADI menée entre le 1er janvier et le 15 juillet...
USA – FDA updates guidance on identifying and responding to deficiencies
The US Food and Drug Administration has revised the guidance document Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions to update the...
Europe – Notified bodies survey on certifications and applications
Notified Bodies Survey on certifications and applications (MDR/IVDR) - MDCG & Stakeholders...
UK – New device launched for diagnosing prostate cancer
CamPROBE may save vital time and money while reducing the risk of infection
November will witness the launch of a new device that is set...
Europe – MDCG 2022-16 – Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical...
Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if...
