AI

The MHRA’s premarket statutory instrument for Great Britain should to be laid before UK parliament in Q2 and be in force by year end, in an ideal world. There are concerns that the new statutory instrument must align with imminent EU MDR changes.

During his 40 years at Royal Philips, Bert van Meurs has seen the medical devices business grow in line with the evolving needs of healthcare providers with whom the company partners in customer and patient focused innovation.

The European Commission seems to have heeded many of the medtech industry’s points regarding challenges with the implementation of the AI Act within the Digital Omnibus. But the usual EU hurdles must be crossed before the sector will know if these proposals will make it into law.

Brain-computer interfaces advance toward trials and commercialization, Oura pushes for FDA-cleared blood pressure monitoring, and regulators weigh AI’s expanding role in mental health and diagnostics amid rising safety concerns.

How will medtech be buffeted by what is seen as the EU’s capitulation to US demands to water down its AI and data regulations?

Samsung Next’s corporate venture capital team employs a differentiated investment policy to the average investor, as managing director Jonathan Machado explained.

India is transforming its medtech sector from a consumer-importer market into an innovator-exporter industry. But stakeholders are aware of a public-private investment imbalance, In Vivo notes in part three of its APACMed 2025 conference report.

The first-of-its-kind sandbox for insights on how to regulate artificial intelligence in healthcare has accepted seven more AI innovators onto its learning program.

As the FDA reviews its lead ADHD candidate, a dexmethylphenidate hybrid, Cingulate is pairing scale-up manufacturing with AI-driven marketing to smooth its transition into commercialization.

One panelist at the BioFuture conference said AI is a bubble, but that when the bubble bursts it will leave a lot of innovation in its wake.

A pioneering initiative, Edvance MedTech, is being launched by leading experts in medical technology regulation which aims get to the heart of what is needed to improve the way EU rules are not only applied but also decided.

India is transforming its medtech sector from a consumer-importer market into an innovator-exporter industry. But stakeholders are aware of a public-private investment imbalance, In Vivo notes in part three of its APACMed 2025 conference report.