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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
The number of EU Notified Bodies empowered to certify devices for a CE mark or CE-in vitro diagnostic (IVD) mark has increased by two, to 27. 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
To date, Philips Respironics has produced approximately 1.5 million repair kits and replacement devices, of which approximately 700,000 have reached customers. Read More
Sweden’s Xvivo touted the success of its heart perfusion device used in the first successful transplantation of a genetically modified pig heart to a human. Read More