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Smartwatches and smart rings that claim to measure blood glucose levels without piercing the skin have not been authorized, cleared or approved by the FDA, the agency has warned in a recent safety communication. Read More
Small medical device manufacturers who are experiencing financial hardship — and are in an active bankruptcy — can look to a new FDA draft guidance for information on how to become eligible for a waiver of their registration fee. Read More
The General Accountability Office (GAO) should press the FDA to stop being passive in its oversight of device safety and instead take a more bold and active role, according to several academicians who collaborated on an opinion piece in the peer-reviewed healthcare journal Health Affairs. Read More
Using the app for two four-hour periods of sleep during the same 10-day period should provide enough data for users to have an informed conversation with a healthcare provider. Read More
This week, your watch can start alerting you to sleep apnea, a fingertip clip can monitor your daytime blood oxygen, and a robotic exoskeleton can help restore mobility to spinal cord injury patients. But in a refreshing win for actual humans, a large study finds that the surgeon’s hands are just as good as robotic techniques in arthroscopic knee repair. Read More
The presentation and accuracy of medical information through traditional and social media — and even the headlines that accompany it — directly impact the nation’s health, FDA Commissioner Robert Califf told a gathering of reporters Wednesday in Washington, D.C. Read More
The FDA has deemed Smiths Medical’s recall of its Medfusion model 4000 syringe pump as Class I for software issues that can make the pump fail and delay or interrupt therapy or fail to deliver therapy according to the programmed setting. Read More
AdvaMed believes “right to repair” was initiated to focus on cars, cellphones and household appliances, and should not drift into medical equipment regulated by the FDA. Read More