Randomized, double-blind, placebo-controlled study to evaluate efficacy of novel pan-GI prokinetic in patients with gastroparesis Renexxion Ireland Limited, a private biopharmaceutical company committed to delivering innovative drugs to patients with high unmet need in gastrointestinal (“GI”) disorders, is pleased to announce that the first patient has been treated in Europe with naronapride, a potential best-in-class […]

The European Commission is proposing to give more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the Medical Devices Regulation. The new deadlines depend on the medical devices’ risk class and will ensure continued access to medical […]

The first US patient has been enrolled at MedStar Washington Hospital Center in the SELUTION4ISR study evaluating SELUTION SLR™ to support FDA approval. This milestone follows Investigational Device Exemption (IDE) approval in the US in October 2022. SELUTION SLR is the first sustained limus release coronary drug-eluting balloon (DEB) to receive FDA IDE approval for In-stent […]

Pie Medical Imaging, a global leader in cardiac imaging, announced the 500th patient inclusion in the FAST III, a multi-center randomized clinical trial, which investigates the use of angiography-based vessel fractional flow reserve (CAAS vFFR) in patients undergoing coronary revascularization procedures. In this trial, a CAAS vFFR guided strategy is compared to a FFR guided […]