FDA is encouraging medical device firms to consider using Bayesian estimation in clinical trials to streamline regulatory timeframes
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Roche Diagnostics, Intuitive Surgical, Abbott and Edwards Lifesciences all acknowledge tariff headwinds, but stress preparedness, resilience and mitigation. Below is look at how management framed the impact in Q1 vs Q2 earnings calls.
Urgent action is needed to address gaps in how risks from medical devices and diagnostics utilizing AI are identified, mitigated and managed. So says James Pink, renowned medtech regulatory expert in an interview with Medtech Insight.
The US FDA has published a list of recommendations for the safe use of hyperbaric oxygen therapy devices. While the therapy can be effective in treating several conditions, the agency says providers need to understand its potential risks.
