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The European Medicines Agency (EMA) has released guidance to devicemakers and notified bodies on how drug-device combination products should comply with the EU Medical Device Regulation (MDR) that went into effect on May 26. Read More
The House Energy and Commerce Committee wants Acting FDA Commissioner Janet Woodcock to explain how the agency plans to address the backlog of nearly 8,000 inspections accumulated during the pandemic as lawmakers worry about the potential impact on the agency’s drug reviews. Read More
Nearly eight years after the FDA published its final rule on the unique device identification (UDI) system, it now has issued final guidance that describes the requirements for the form and content of the UDI system. Read More
The clinical trial will evaluate 263 patients who are being treated at two vertebral levels either with the M6-C disc or with discectomy and fusion. Read More
The excimer laser, which emits very concentrated ultraviolet light, and the single-use catheter system are used for removal of blockages resulting from lower extremity vascular disease. Read More
The 3D visualizations allow physicians to interact with holograms of the patient's actual anatomy prior to and during interventional procedures without the need for a head-mounted device, special eyewear or interaction tools. Read More