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Companies need to institute more controls over what data is going to entities in China and five other “countries of concern” under the US Department of Justice’s Data Security Program, which took effect earlier this year.
Challenges to biotech financing continue to increase, but medtech financing, already fragile, is holding steady, with interest in cardiovascular and neurotech devices gaining traction in the first half of 2025. More than ever, risk-averse investors favor later-stage companies that have established commercial track records, while they persist in shunning earlier-stage companies, particularly those that are raising money to start their first clinical trials.
The TGA’s policy development plans for AI medical device software. Excerpted from Pathways’ Picks July 30: User Fee Hike, Australia AI Plans, Notified Body Governance Proposal.