Posts Tagged FDA

FDA Updates Providers on Lymphoma Risk Associated with Breast Implants

The Food and Drug Administration recently updated health care providers about a type of lymphoma associated with breast implants and recommendations to inform patients about the risk and report, evaluate and treat the condition. Providers, patients and manufacturers have reported 457 cases of breast implant-associated anaplastic large cell

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FDA Issues Draft Guidance on Cybersecurity for Medical Device Industry

The Food and Drug Administration today issued draft guidance that provides recommendations to the medical device industry on cybersecurity considerations for device design, labeling and documentation that the FDA recommends be included in premarket submissions for medical devices with cybersecurity risk. The guidance builds on the

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FDA Announces Actions to Strengthen Medical Device Cybersecurity

The Food and Drug Administration has released a framework to help hospitals and other health care providers plan for and respond to cybersecurity incidents involving medical devices. Developed by MITRE Corp., the “playbook” includes steps such as developing a medical device inventory and conducting training

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NASEM To Develop New Opioid Prescribing Guidelines

The Food and Drug Administration has awarded a contract to the National Academies of Sciences, Engineering, and Medicine to develop evidence-based guidelines for appropriate opioid analgesic prescribing for acute pain resulting from specific conditions or procedures. FDA Commissioner Scott Gottlieb, M.D., said the “primary scope

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FDA Issues Safety Alert on Temporary Artificial Heart

The Food and Drug Administration Aug. 17 issued a safety alert after reviewing the final results from a post-approval study conducted by SynCardia Systems for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System. SynCardia’s TAH-t functions as a bridge to a heart transplant

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FDA alerts providers to safety risks associated with cesium chloride

The Food and Drug Administration recently alerted health care providers to safety risks associated with cesium chloride, a mineral salt sometimes taken by cancer patients who seek alternative treatments. Reported adverse events included QT prolongation (a dangerous abnormality that can impair the heart’s ability to

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FDA: 39 new drug shortages, 41 ongoing shortages in 2017

The Food and Drug Administration identified 39 new drug and biological product shortages in 2017, up from 26 in 2016, and 41 ongoing shortages from prior years, according to the agency’s latest annual report on the issue. The FDA recently stated that shortages of intravenous saline and

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FDA: Don’t use certain multi-patient endoscope connectors

Healthcare providers should not use endoscope connectors labeled for use without reprocessing between patients because they carry a risk of cross-contamination, the Food and Drug Administration announced last week. “To date, the FDA has not received acceptable testing to demonstrate the safe use of these

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FDA issues plan to improve medical device safety

The Food and Drug Administration has released a plan to improve medical device safety. The plan calls for increased funding to develop an active surveillance capability for FDA’s National Evaluation System for health Technology (NEST) and conduct post-market studies to evaluate specific safety concerns. The

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FDA announces firmware update for certain Abbott cardiac devices

The Food and Drug Administration recently announced a firmware update to reduce the risk of rapid battery depletion and address cybersecurity vulnerabilities in certain Abbott devices that provide pacing for slow heart rhythms and electrical shock or pacing to stop dangerously fast heart rhythms. The

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