Clinical Performance Evaluation of IVDs
Wien, 01.08.2024 – Text: Catarina Carrão In vitro diagnostic (IVD) medical devices In vitro diagnostic (IVD) devices play a critical role whether to help diagnose diseases or conditions, monitor health status, or guide treatment decisions. For these reasons, a new Amending Regulation [EU 2024/1860] was published in July 2024 to extend the IVDR transition timelines while […]
Clinical evidence: essential for both investors and regulators
Wien, 09.07.2024 – Text: Catarina Carrão Medical technology start-ups: popular demand The need for innovative healthcare solutions is high, as such medical technology start-ups are increasingly popular. Whether developing new technologies, devices, and/or software that has the ability to improve patient outcomes and reduce healthcare costs, the incentive is there to identify a niche and develop something new. However, […]
Orphan medical devices: balancing the needs for clinical evidence
Wien, 02.07.2024 – Text: Catarina Carrão Rare diseases in the EU In the European Union (EU), 27 to 36 million people live with one of the estimated 6,000 to 8,000 rare diseases, which can affect anywhere from a few patients to as many as 245,000.1 Approximately 80% of these diseases are genetic, with 70% beginning […]
