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The recall of millions of Philips Respironics continuous positive airway pressure (CPAP) devices for treatment of sleep apnea continues to impact activities that would not automatically come to mind, such as commercial trucking. Read More
The FDA’s Center for Devices and Radiologic Health (CDRH) seems to have gotten bogged down in its efforts to meet its commitments under the fourth iteration of the Medical Device User Fee and Modernization Act (MDUFA IV), according to the consultancy Booz Allen Hamilton. Read More
Eudamed, the European database on medical devices, will be offline for several days to allow for a “major upgrade” as new functions are about to come online, the European Commission said. Read More
The FDA’s current system of device approvals is letting serious safety problems slip through the cracks, suggests an editorial in the American Medical Association’s Journal of Ethics. Read More
The FDA’s Safer Technologies Program (STeP) for Devices provides similar agency resources and priority review to sponsors whose devices do not meet the criteria for breakthrough status. Read More
Regulatory authorities in several countries are concerned about a prenatal test made by Shenzhen, China-based BGI group that screens for Down syndrome and other genetic conditions. Available in 52 countries, the prenatal test collects DNA of women and fetuses. Read More
Expert panels in the European Union will be evaluating some high-risk devices for compliance with the EU’s In Vitro Diagnostic Regulation (IVDR) and they are now accepting applications. Read More
Australia’s Therapeutic Goods Administration (TGA) has filed a lawsuit in the Federal Court of Australia against Medtronic Australasia for the alleged unlawful supply of the company’s Infuse bone graft kit, which contains a medicine and other components to stimulate bone growth in patients. Read More