Proportionately regulating highly adaptive AI as a medical device can be done with predetermined change control plans. The US, UK and Canada are advancing the concept, as Ropes & Gray and the US FDA explained.
Device and healthtech innovation is prone to getting ahead of regulation. The arrival of artificial intelligence as a medical device (AIaMD) is testing processing capacities to the limit, which is where pre-determined change control plans (PCCP) can serve a useful purpose.
AI/machine learning technological advances will continue to challenge regulatory systems around the world, Ropes & Gray’s Lincoln Tsang believes.
Annual survey of patients and professionals shows how attitudes to health system transformation are evolving and what stakeholders are demanding as acceptance of AI tools accelerates.
BioWales in London 2025 showcased the efforts healthtech innovators are making to meet investors on their own turf, illustrating changing attitudes and evolving needs.
Metsera CEO Whit Bernard applies an unconventional leadership philosophy to develop next-generation obesity therapeutics, including monthly GLP-1 injections and oral peptides.
