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The software automatically detects suspected large vessel occlusion strokes on computed tomography angiography images and alerts on-call specialists. Read More
The Axiostat patch has bioadhesive properties that provide a strong mechanical barrier at the site of an injury, keeping out bacteria and reducing recovery time. Read More
Clinicians can use the software to securely exchange documents, such as lab results, with transplant patients and can offer personalized advice. Read More
Australia’s Therapeutic Goods Administration is proposing to ease certain requirements in its regulatory framework for custom-made and 3D-printed devices that became effective in February. Read More
International Medical Development did not take adequate corrective and preventive actions for quality deficiencies at its Huntsville, Utah, plant, the FDA found in a Feb. 8-12 inspection. Read More
Groups that will be impacted by the EU’s In Vitro Diagnostic Regulation (IVDR) are calling for urgent action to further delay its May 26, 2022 effective date and for a phased implementation. Read More
Validation issues, design control and inadequate corrective and preventive procedures were among the quality system failures cited in a warning letter to Wheat Ridge, Colorado-based DeChoker following a Feb. 17-26 FDA inspection. Read More
The FDA’s Center for Devices and Radiological Health (CDRH) may reject medical devices submitted for premarket approval when the agency is not satisfied that they have adequate cybersecurity, says Kevin Fu, who was appointed to the new position of the agency’s acting director of medical device security earlier this year. Read More
The FDA issued a warning letter to Innova Medical Group in Pasadena, California for false and misleading labeling for its SARS-CoV-2 antigen rapid qualitative test, as well as marketing the test without FDA clearance and a slew of GMP observations at two facilities. Read More