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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. Read More
Under a settlement with the Federal Trade Commission, devicemaker NeuroMetrix agreed to pay at least $4 million and 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 issued warning to four devicemakers for lax design controls, inaccurate labeling and other serious failures at their manufacturing facilities. Read More
The FDA announced in a new guidance that it does not plan to object to delays in adverse event reporting for medical products during the pandemic. Read More
The FDA issued a new policy that allows the use of validated COVID-19 diagnostics while the agency reviews Emergency Use Authorization (EUA) requests. Read More
The European Commission has authorized the National Standards Authority of Ireland (NSAI) as the 11th notified body under the EU’s Medical Device Regulation. Read More
The FDA clarified what information devicemakers should include in their 510(k) premarket submissions for peripheral vascular atherectomy devices in a new final guidance. Read More