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The Centers for Medicare and Medicaid Services has finalized a rule to promote quicker access to new medical technology through changes in payment policies.August 6
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Two types of hospital anesthesia devices manufactured by GE Healthcare contain significant cyber vulnerabilities, a federal agency contends.July 11
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Agency says the vendor is unable to adequately update devices with software or patch them to address vulnerabilities.June 28
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The Food and Drug Administration has plans to make the database that houses medical device reports submitted to the agency more user friendly.June 24
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The Department of Homeland Security is warning of vulnerabilties in BD Alaris Gateway workstations that could enable hackers to manipulate them remotely.June 14
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The Federal Bureau of Investigation is re-emphasizing the security risks of Internet of Things devices, saying providers and other organizations should step up oversight of the devices.June 14
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The American Medical Informatics Association wants the Food and Drug Administration to improve its conceptual approach to regulating medical devices that leverage self-updating artificial intelligence algorithms.June 11
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Agency is looking for volunteers planning to submit a De Novo Request or 510(k) submission to evaluate Pre-Cert working model.May 28
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Agency reports that unauthorized system resulted in an insulin overdose requiring medical intervention.May 20
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Agency is trying to harmonize coverage, coding and payment processes for transformative technologies.May 3
