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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
Aggredyne drew a Form 483 from the FDA for deficient design change validations and other lapses following an inspection of its Houston, Texas, manufacturing facility from March 29 to April 14. 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
To ensure an effective complaint-handling system, it is important to define complaint types. A key part of these definitions must include which types warrant further investigation and which need to be escalated — in other words, determining which complaints qualify as serious. Read More