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In a separate 13-3 vote with two abstentions, the expert panel concluded that the risks of the Neovasc Reducer System outweigh the benefits for specific patients. Read More
“The diagnostic performance of the test is particularly good in samples with viral loads associated with high risk of viral transmission,” the researchers said. Read More
DIOSynVax is developing its COVID-19 vaccine using computer modeling to identify the virus’ genetic code in the hopes of producing a vaccine that is specific to developing antibodies against SARS-CoV-2. Read More
A study assessing the FDA’s De Novo premarket review pathway found that some devices received clearance without supporting data from pivotal clinical trials. Read More
Of the devices that did go through pivotal trials, 31 percent failed to meet at least one primary efficacy endpoint, but the devices still earned clearance, the researchers found. Read More
The system was chosen for the study “due to its record of increasing the efficacy of DNA vaccines and the speed of the delivery system compared to traditional needle and syringe,” the company said. Read More