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Illumina has launched its cancer diagnostic test, TruSight Oncology (TSO) Comprehensive (EU), in Europe — calling it the first CE-marked in vitro diagnostic (IVD) kit for comprehensive genomic profiling based on DNA and RNA content. Read More
The FDA has posted a warning on its website against using Apyx Medical’s Renuvion/J-Plasma device for aesthetic dermatology procedures, which has caused burns and other serious adverse events. Read More
Philips said the remote diagnosis system could help limit the risk of exposure for healthcare workers and patients to infectious diseases, such as COVID-19. Read More
The enhanced scanner improves visualization and segmentation of bone, blood clots, plaque, hemorrhage and intracranial tumors, the company said. Read More
The FDA has issued a Form 483 to Enthermics Medical Systems, based on an inspection last September of the company’s facility in Menomonee Falls, Wis. Read More
San Francisco, Calif.-based ProSomnus Sleep Technologies said that several postmarket studies of its EVO Sleep and Snore Device have shown it be an effective alternative to continuous positive airway pressure (CPAP) therapy in treating obstructive sleep apnea (OSA). Read More