FDA

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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FDA chief sees big things for AI in healthcare

Scott Gottlieb, MD, is bullish on the opportunities artificial intelligence could bring to EHRs, decision support and more.At AcademyHealths 2018 Health Datapalooza on Thursday, the U.S. Food and Drug Administration offered a vote of confidence for artificial intelligence in healthcare, promising more refined strategies for regulation, touting its tech incubator for AI innovation and announcing

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FDA takes a longand long-termlook at device safety in new plan

The Food and Drug Administration appears to be taking a proactive and long-term approach toward improving medical-device safety. On April 17, the FDA released its Medical Device Safety Action Plan, in which regulators set out their goals for improving device safety, including tracking a product’s safety throughout its life-cycle and catalyzing innovation that will make

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