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Philips has reached a $4.2 million settlement with the U.S. Department of Justice (DOJ) under the False Claims Act over its IntelliVue MP2 mobile patient monitors. Read More
A federal appeals court has ruled that a complaint by a Kentucky woman against the Johnson & Johnson subsidiary Ethicon over two pelvic mesh devices may proceed. Read More
A federal jury in Delaware has awarded Lake Ozark, Mo.-based Osseo Imaging $2.3 million in its patent infringement lawsuit against Planmeca USA for allegedly infringing on three dental and orthopedic imaging patents. Read More
A position paper from the European Commission’s Medical Device Coordination Group (MDCG) proposes a list of actions aimed at easing the burden of notified bodies (NB) under the EU’s new regulations, including use of hybrid audits and evidence from previous assessments. Read More
Integra LifeSciences has issued a global recall of all its CereLink intracranial pressure (ICP) monitors due to customer reports of pressure readings that were out of range. Read More
Campbell, Calif.-based Imperative Care’s Zoom Stroke Solution proved safe and effective in treating distal vessel occlusions in ischemic stroke patients, according to study results presented at the World Federation of Interventional and Therapeutic Neuroradiology’s annual meeting in Tokyo this week. Read More
In a move to increase patient access to certain medical devices, the Centers for Medicare and Medicaid Services (CMS) said it plans to discontinue the use of two cumbersome medical device forms for claims with dates of service on or after Jan. 1, 2023. Read More