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The European Commission’s Medical Device Coordination Group announced that a new Eudamed registration module will go into effect on December 1, enabling users to create a unique single registration number (SRN). Read More
The FDA has granted Abbott Laboratories an Emergency Use Authorization for its COVID-19 antigen test, a diagnostic that provides fast, readable results on a card similar to some pregnancy tests. Read More
In a dramatic policy reversal instigated by President Trump, the FDA will no longer require lab-developed tests (LDTs) for COVID-19 to undergo premarket review, the Department of Health and Human Services (HHS) announced Aug. 19. Read More
The system “leaves less metal behind when compared to stents, preserving future treatment options and limbs while also offering a solution for repairing dissections and optimizing postangioplasty outcomes,” Philips said. Read More
The equipment “will allow patients to be safely transitioned into the MRI suite without the interruption of infusion therapy,” the company said. Read More
The company’s Flow-e system is a large workstation for personalized anesthesia delivery, offering a larger worktop, more storage space and multiple mounting options for auxiliary equipment. Read More
"The Healeon Duet overcomes one of the most challenging parts of platelet preparation – customizing concentration levels in controlled dosages for specific procedure types in a single platform," said Healeon CEO Jeff Greiner. Read More
The test provides comprehensive genomic profiling results, reporting on genomic alterations that include genomic signatures and single-gene alterations. Read More