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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
The FDA has released safety reviews of four materials commonly used in implantable medical devices and the effects of the materials on patients over time. Read More
Each of MedCAD’s AccuPlate Patient-Specific Plates are designed based on the patient's scanned anatomical data in consultation with MedCAD and the surgeon, and milled out of pure, implant-grade titanium. Read More