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“Right now, we have no evidence that the use of a serologic test can show that an individual is immune or protected from reinfection,” the WHO official said. 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. 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 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 EU’s Medical Device Coordination Group released a guidance for devicemakers on transitional provisions for Class I devices under the Medical Device Regulation (MDR). Read More
Australia’s Therapeutic Goods Administration (TGA) fined Oxymed Australia A$63,000 ($40,000) for making false claims that its hyperbaric oxygen therapy chambers can treat a variety of conditions, including COVID-19. Read More