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The FDA expedites regulatory reviews of breakthrough devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Read More
Sherlock Biosciences CEO, Bryan Dechairo, said the company’s CRISPR diagnostic technology can enable increased access to diagnostics globally. Read More
The new console delivers advancements in imaging, portability and capability that will support new catheter capabilities in the future, according to the Redwood City, Calif.-based company. Read More
The test has demonstrated 95 percent sensitivity and 100 percent specificity for detecting tumor DNA concentration levels as low as 11 parts per million, the company said. Read More
In a final rule released yesterday, the FDA said that it will no longer publish its quarterly approvals and denials of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs) in the Federal Register. Read More