RightEye gets FDA nod for eye-tracking technology
Maryland-based RightEye now has clearance for its software that helps clinicians assess reading skills, brain health and functional vision.
[ Read More ]FDA to include cybersecurity bill of materials in medical device premarket guidance
As part of a series of announcements around medical device cybersecurity, FDA Commissioner Scott Gottlieb, M.D., said the agency plans to update premarket guidance in the coming weeks to recommend that manufacturers include a cybersecurity “bill of materials.” The agency also issued a new “playbook” for health systems responding to an attack.
[ Read More ]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
[ Read More ]FDA unveils cybersecurity attack response playbook for medical devices
In a statement, Dr. Scott Gottlieb detailed his agencys ongoing cybersecurity efforts, which include the signing of two significant memoranda of understanding and discussions to facilitate collaboration across government agencies.
[ Read More ]How the FDA is shaping healthcare innovation
In the last year the FDA has taken steps to evolve its process for regulating software as a medical device, personal genomics and clinical decision support technology. In many ways the gatekeepers of healthcare innovation and advancement in the US, the FDA is key in shaping the future of the healthcare industry both in America
[ Read More ]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.”
[ Read More ]FDA awards $225M IT contract to track drug performance
The agency selected three contractors to help develop an IT system that will analyze the performance of drugs and vaccines on the market. The Food and Drug Administration awarded contracts worth up to $225 million combined to three companies Monday to help develop an IT system that will track and analyze the performance of drugs,
[ Read More ]FDA: Make Sure EHRs Used for Clinical Studies Are Secure
The Food and Drug Administration has issued new guidance spelling out its policy for organizations using electronic health record data in FDA-regulated clinical investigations, such as studies of the long-term safety and effectiveness of various drugs. Among other criteria, the EHRs need to contain certain privacy and security controls, the FDA says.
[ Read More ]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
[ Read More ]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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