FDA

FDA Reveals Steps to Bolster Medical Device Cybersecurity

In a statement Monday, FDA Commissioner Scott Gottlieb, M.D., says the efforts are aimed at addressing growing cybersecurity threats and potential related patient safety worries for network-connected medical devices.”As the number of cyberattacks has increased, we’ve heard concerns about the potential for cybercriminals to attack patient medical devices,” Gottlieb says.Cybersecurity researchers continue to identify device

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FDA to Ramp Up Medical Device Cybersecurity Scrutiny

The Department of Health and Human Services’ Office of Inspector General’s report recommends that FDA better integrate the review of cybersecurity in the agency’s processes for premarket assessments of medical devices.In a statement provided to Information Security Media Group, FDA says it’s taking steps to bolster its “already robust premarket review of networked medical devices.”

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FDA Regulation of Mobile Medical Apps

obile apps are increasingly used in health care to promote wellness, treat and diagnose disease, aid clinical decision-making, and manage patient care in hospitals and homes.Historically, health care has been slow to implement disruptive technology tools that have transformed other areas of commerce and daily life. One factor that has been cited is uncertainty surrounding

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Senseonics gets FDA clearance for Eversense, will sell implantable glucose monitor directly in US

At long last, Eversense, the implantable continuous glucose monitoring system from Senseonics, has received FDA clearance to be marketed in the United States.The FDA is committed to advancing novel products that leverage digital technology to improve patient care, FDA Commissioner Dr. Scott Gottlieb said in a statement. These technologies allow patients to gain better control

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FDA Unveils Plan for ‘Software as a Medical Device’ Review

The proposed voluntary program is for review of “software-as-a-medical-device” products, or SaMD – software that is “intended to treat, diagnose, cure, mitigate or prevent disease or other conditions.” Today, such software faces the same regulatory review as medical device hardware.Examples of SaMD range from software that allows a smartphone to view images obtained from a

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