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Under a settlement with the Federal Trade Commission, devicemaker NeuroMetrix has agreed to pay at least $4 million and to stop making deceptive claims that its Quell transcutaneous electrical nerve stimulation device treats pain throughout the body when placed below the knee. Read More
The FDA released final guidance detailing how the agency approves third-party review organizations and which devices are eligible for third-party evaluations. Read More
The FDA issued a final rule banning electrical stimulation devices (ESDs) used to reduce aggressive or self-harming behavior, saying that better treatment options are now available to treat those issues. Read More
The FDA’s fiscal year 2021 budget request seeks an increase in funding to continue building the agency’s medical device safety monitoring system and to keep pace with AI innovations, FDA Commissioner Stephen Hahn said in testimony before a House Appropriations subcommittee. Read More
The FDA issued a new policy that will allow certain laboratories to use validated COVID-19 diagnostics while the agency reviews their Emergency Use Authorization (EUA) requests. Read More