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Philips has agreed to pay more than $24 million to resolve False Claims Act allegations that it misled federal health care programs by paying kickbacks to durable medical equipment (DME) suppliers, said the Department of Justice (DOJ) in a statement. Read More
A pilot project to help melanoma patients track and manage their symptoms and improve communication with their doctors is growing into a full-blown partnership between Kaiku Health and Novartis. Read More
The FDA has denied a request by Intarcia for a hearing on its New Drug Application (NDA) for the company’s investigational drug-device product ITCA 650 (exenatide) for treatment of type 2 diabetes. Read More
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