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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
While consumers wanting the ability to fix products they’ve purchased came through with over 1,600 comments and strongly-worded frustrations supporting their “right to repair” their own possessions, the issue continues to rankle medical device makers looking to protect their intellectual property rights and the safety of FDA-regulated medical devices. Read More
Consistent open communication and complete public transparency is the only way to counteract scientific misinformation, which is a considerable threat to public health today, said Kimberlee Trzeciak, deputy chairman of FDA’s Office ofPolicy, Legislation, and International Affairs. Read More
Rather than trying to predict which medical devices could be in short supply during a national emergency, the FDA should focus on identifying those that are “mission critical” to patient care, according to an agency advisory committee. Read More