Acutus Medical announced receipt of a CE Mark issued under the European Union Medical Device Regulations for its AcQMap 3D Imaging and Mapping Catheter, the world’s only integrated high-resolution ultrasound imaging and non-contact mapping catheter. The EU MDR was established to create a more robust legislative framework to better protect public health and patient safety. Acutus will file for EU MDR approval for the remaining products in the company’s portfolio to ensure compliance by the May of 2024 deadline. This will allow physicians to have long-term access to the company’s full portfolio of differentiated mapping, ablation, and EP accessory products.
Published first on TheFly
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