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Natera’s Prospera lung donor-derived DNA test has shown positive results in a study assessing rejection and lung-function injury in transplant patients. Read More
When examining submissions for approval or clearance of device software, the FDA will carefully assess whether it has adequate cybersecurity, the agency said in a draft guidance released yesterday. Read More
The clearance covers the device’s use in an anterior approach that will be particularly useful for deformity correction, said Stéphane Bette, SpineGuard’s co-founder and deputy CEO. Read More
Fort Worth, Tex.-based Sanara MedTech has high hopes for a promising wound imaging device and a companion biomarker assay it is gaining as part of its $5.1 million purchase of Precision Healing of Newton, Mass. Read More
Customers who don’t have access to an appropriate sterilization method should stop using the devices and return them to the manufacturer, the FDA said. Read More