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The FDA issued an advisory yesterday about potential airway obstruction and ventilation failure from the use of Medtronic’s silicone-based electromyogram (EMG) endotracheal tubes. Read More
In remarks yesterday before a Senate subcommittee to discuss the FDA’s fiscal 2023 budget request, FDA Commissioner Robert Califf focused on hoped-for initiatives to shore up cybersecurity and the supply chain for devices, and touched on what may become of Emergency Use Authorizations (EUAs) for devices after the public health emergency is declared over. Read More
A retrospective study of GeneDx’s genetic test for autism spectrum disorder (ASD) showed higher diagnostic rates and shorter diagnosis wait times than traditional genetic testing methods, according to the company. It also identified genes that were not previously linked to autism. Read More
Labcorp, one of the nation’s largest diagnostic test companies, has launched an at-home test collection service that combines the company’s diagnostic tests with Getlabs’ at-home phlebotomoy service. Read More
Physician-inventors who own device companies have some relief from worrying about violating the federal Anti-Kickback Statute (AKS), thanks to a favorable advisory opinion from the Department of Health and Human Services (HHS). Read More
The handheld device “offers the same high-performance imaging as a traditional ultrasound scanner for a fraction of the cost,” the Vancouver-based company said. Read More