NESTcc adds laboratory and patient engagement experts to Governing Committee CONTEXT: The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), Continue Reading
CONTEXT: “Data monetisation in the Med Tech environment”. I have to be honest – I’ve read this article twice and still not entirely sure what this actually means in real Continue Reading
CONTEXT: An august meeting of medical societies in Brussels to debate a few interesting topics for our discerning readers | Firstly the implications of the new IVD regulations which are definitely Continue Reading
CONTEXT: This peer reviewed report on an open label extension to a pivotal ADHD study wouldn’t normally get out attention, but the treatment of kids using digital tech had us Continue Reading
CONTEXT: This is a great article on just how valuable RWR / RWE is becoming for regulators worldwide as they will invariably follow the FDA’s lead | Be honest if the Continue Reading
CONTEXT: Opinion piece on the developing FDA guidance and legislation to come on medical devices. This I going to be especially interesting for SaaMDs and AI in medical devices. IMPACT: Continue Reading
CONTEXT: An interesting article highlighting the FDA’s position on RWR in the rapidly developing field of AI within SaMD. Within the proposed FDA framework, in the post-marketing realm, quote “the Continue Reading
CONTEXT: FDA publishing an action plan on AI in SAAMDs. China already ahead of the game in terms of how they have already enacted guidance on AI in SAAMDs, but Continue Reading
CONTEXT: European initiative to explore “In-Silico” research. Not so much “Real World” as “Brave New World” utilising computer models to test safety and efficacy of medical devices. Hopefully this isn’t Continue Reading
CONTEXT: FDA publishing an action plan on AI in SAAMDs. China already ahead of the game in terms of how they have already enacted guidance on AI in SAAMDs, but Continue Reading
