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The device received previous breakthrough designations for coronary in-stent restenosis, peripheral below-the-knee and AV-Fistula indications. Read More
The devices are intended for use in orthopedic surgeries for fixation of ligaments or tendon tissue repairs of the knee, shoulder, elbow, wrist, hand, ankle and foot. Read More
The test showed it could detect a SARS-CoV-2 T cell mediated immune response in patients who tested positive for coronavirus, even when they had negative serology test results for antibodies. Read More
The assay runs on the company’s Alinity m system, a polymerase chain reaction (PCR) platform that that offers a turnaround time for assays of less than 115 minutes. Read More
Prior to joining Walmart, Smith was Goodyear’s senior vice president of global operations, handling 52 manufacturing facilities across four business units. Read More
The Valencia, Spain-based company said qp-Prostate is the only technology available that offers automatic regional organ segmentation that can help reduce interpretation time by identifying and segmenting each prostate region. Read More
Beginning Feb. 25, the way that software-based medical devices are regulated in Australia will change, and clinical decision support software (CDSS) that meets the definition of a medical device must be included in the Australian Register of Therapeutic Goods. Read More
SGS FIMKO Oy, a Helsinki-based subsidiary of the certification giant SGS, became the 18th notified body to be designated to provide product certifications under the European Medical Device Regulation (MDR). Read More
The European Commission released new guidance explaining how Legacy Devices will be identified in the Eudamed database and how their unique device identifiers will be generated and assigned. Read More
The FDA’s top device officials admit that allowing a flood of COVID-19 diagnostic tests onto the market last year that did not go through the usual clearance or approval steps was a “flawed” approach. Read More