FDA clears SmartCapnoLine O2 capnography device for use in sedated, non-intubated patients to detect potentially fatal adverse events that can occur during sedation including apnea, ventilatory depression and airway obstruction. The product is in compliance with updated 2001 Joint Commission on Accreditation of Healthcare Organizations standards that call for monitoring ventilation in patients...
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In this in-depth interview with Medtech Insight, Pavan Choudary unpacks the implications of recent free trade agreements (FTAs) such as India’s with the UK, the potential fallout from new US tariffs on Indian device exports, and the pressing need for regulatory harmonization.
The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.
EU countermeasures against US tariffs suggest medtech categories exported to the EU could be targeted for tariffs. MedTech Europe and the German IVDs industry have stressed the negative effects this would have on patient care.
