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 […]
Medical device provider Mindray has become one of the first manufacturers in the world to receive certification for its defibrillators, under the European Union’s newest Medical Device Regulation (MDR).
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 […]
PENTAX Medical INSPIRA™ video processor (EPK-i8020c) and the i20c endoscope generation obtain CE marks
Pie Medical Imaging (“PMI”), a global leader in cardiac imaging, today launched CAAS Qardia 2.0, a new version of their innovative echocardiography software platform. CAAS Qardia leverages artificial intelligence driven workflows for performing key clinical measurements and ease-of-access.
International medical imaging IT and cybersecurity company Sectra (STO: SECT B) has signed a digital pathology contract with the public hospitals in Roubaix and Mouscron. The two hospitals, situated on either side of the French/Belgian border, will utilize a joint Sectra digital pathology solution to enhance their collaboration. The tools provided in the digital workflow […]
RaySearch Laboratories AB (publ) is proud to announce that the number of radiotherapy centers in Japan that are using RayStation for treatment planning has surpassed 200. In terms of number of centers, Japan is RaySearch’s second largest market.
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