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With MDCG guidance on change control promised by year’s end, notified bodies and experts weigh in on how much latitude device and digital health firms should have in making product modifications, and where PCCPs fit in. Europe could offer more room than the US for continuous innovation—if it can settle on which changes need notified body approval.
In this month's news, 510(k)s for several AI image analysis tools, Steris buys Xodus Medical for $2.1 billion, developments in the Delphi and READI-Home programs for patient-used products, and more.
Medtech companies, weighed down by depressed stock prices and market challenges, are under intense pressure to step out of their comfort zones and make bets on innovation that will drive their future. Excerpted from our recent feature article, Despite Headwinds, A Nascent Medtech Rebound Is Fueling M&A.