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Juniper Research is pleased to announce that entries are now open for the Future Digital Awards for Digital Health Innovation 2023. Since 2008, the Future Digital Awards have been awarded to tech companies at the forefront of their respective fields. This includes companies delivering products or services which are innovative, have the potential to disrupt their ecosystems, and provide […]
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.