The U.K. is mulling over whether to recognize U.S. FDA approvals of medical devices as part of moves to accelerate the implementation of its post-Brexit regulatory system.
The European Commission has given in to the increasing pressure and alarm from member states and is moving to extend the deadlines for implementing the 2017 Medical Device Regulation (MDR) and the In Vitro Devices Regulation (IVDR).
Natus Medical Inc. entered into a definitive agreement to acquire EU-based neurophysiology solution provider Micromed Group SpA. The transaction is expected to close in early 2023, subject to regulatory approvals from the Italian Council of Ministers’ Presidency and the French Ministry of Economy and Finance. Full terms of the transaction have not been disclosed. “The idea behind this acquisition is to provide a single portfolio of neurodiagnostic and neuromonitoring products in the EU and the whole world,” Thomas Sullivan, CEO of Natus Medical, told BioWorld.
Mainstay Medical Holdings plc released data from a one-year, real-world, study of patients implanted with a neurostimulation device to treat chronic lower back pain.
Switzerland is making moves to allow the import of U.S. FDA-approved medical devices after losing barrier-free access to the EU market and over rising concerns about the dismal pace of implementation of the EU’s upgraded devices regulations.
Uromems SAS reported the successful completion of the first-in-human implant of a smart, automated artificial urinary sphincter (AUS) device for treating stress urinary incontinence (SUI). This initial pilot study recently saw the first male patient implanted with the Uroactive System at Paris’s La Pitié-Salpêtrière University Hospital and is considered by the company to be a key milestone in the technology’s development.
Vaudois University Hospital (CHUV), in conjunction with the European laboratory for particle physics (CERN) and Theryq SAS, has signed an agreement to develop equipment for a novel radiotherapy technique known as “electron Flash therapy.” The new device will use very high energy electron (VHEE) radiation to treat cancers resistant to conventional therapy.
A variety of governmental entities in the EU are feeling pressure to address the issues with the rollout of the Medical Device Regulation, and some EU member states have taken matters into their own hands.
Surgibox Inc. won a CE mark for two components of its Surgifield system, an ultraportable sterile system that enables safe surgery any place, any time. The five-year-old startup also landed a humanitarian use exemption for use of the system in war-torn Ukraine.
The U.K. National Institute for Health and Care Excellence has expanded its endorsement for the Greenlight XPS system for benign prostatic hyperplasia to no longer exclude patients deemed at high risk for hemorrhage, a decision that may boost utilization and thus sales of the XPS.
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