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The handheld device directs precise wavelengths of targeted light to the back of the throat and surrounding tissues and is designed for at-home treatment of mild-to-moderate COVID-19 in adult patients. Read More
The coronavirus treatment candidate, which is delivered by a pressurized metered-dose inhaler, has both bronchodilator and anti-inflammatory activities, the company said. Read More
The FDA is currently working with test developers and conducting ongoing data analyses to evaluate all authorized tests, but said it believes there is only a low risk of mutations affecting overall testing accuracy. Read More
ISU’s vaccine is “intended to address some of the limitations of the vaccines currently in development by targeting room temperature storage and single-dose nasal self-administration as key capabilities,” Zeteo said. Read More
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