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Many companies are still working to fully transition their product portfolios from certificates granted under the legacy EU Directives to CE marks awarded via the Medical Device or IVD Regulations. Here's the status of those efforts based on survey responses from notified bodies and manufacturers.
Today’s catheter-based system for urodynamic testing is often uncomfortable and painful, such that it’s almost a last resort, even though it’s the only tool clinicians have for accurately diagnosing and treating the causes of lower urinary tract symptoms. Urologic Health aims to burst that bottleneck with a new, noninvasive modality for urodynamic testing.
FDA plans to exempt more unclassified devices from premarket notification requirements. Excerpted from Pathways’ Picks June 11: Opposition to EU WET Exemptions, Medicare Coverage Updates, and More.