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.
MedTech Forum 2025 was less MDR-focused than in previous years, as macro issues and exogenous threats were forced further into the center of medtech business thinking.
In a conversation with In Vivo, CEO Jon Congleton discusses Mineralys’s data-rich journey toward an NDA filing, the significance of recent trial wins and how its candidate may offer a dual benefit in blood pressure and renal protection.
Qubit Pharmaceuticals and Sorbonne University launched a quantum AI model that could slash drug synthesis requirements and enable exploration of previously undruggable targets.
