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Philips Respironics, a subsidiary of Philips Healthcare, has initiated a voluntary worldwide recall of about 600 Trilogy ventilators due to a potentially defective component on the power management board. Read More
There’s now a strong possibility the European Parliament won’t finalize proposed medical device and IVD regulations before elections this May, a lawyer familiar with the legislation says. Read More
The FDA’s monitoring of in-house emails of five agency whistleblowers that went public with product safety complaints was not supported by agency policy and may have violated the Fourth Amendment and the Whistleblower Protection Act, House Republicans and an HHS watchdog charged Wednesday. Read More
FDA advisors Wednesday urged the agency to rescind the OTC bronchodilator monograph for epinephrine and racepinephrine products delivered via a hand-held rubber bulb nebulizer, saying the combination products present safety concerns that only an NDA can address. Read More
Florida-based RTI Surgical announces the U.S. launch of its MaxFuse Vertebral Body Replacement System and Aspect Anterior Cervical Plate System. Read More