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Alexandria, Va.-based Spok received a Form 483 after an April inspection by the FDA found incomplete corrective and preventive action (CAPA) procedures and design control lapses. 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
Patients with type 1 diabetes using Medtronic’s MiniMed 780G insulin pump system had reduced blood glucose levels and increased time spent in the target blood sugar range compared to patients given insulin injections, researchers reported in the journal The Lancet Diabetes & Endocrinology. Read More
In observance of Labor Day holiday, FDAnews Device Daily Bulletin Premium will not be published Monday, Sept. 5. The next issue will be published Tuesday, Sept. 6. 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
One aspect of document management systems is maintaining an audit trail of electronic records. Maintaining an audit trail protects the authenticity, integrity, and, when appropriate, the confidentiality, of electronic records. Read More