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BRS has expanded its Richmond facility to include a 15,000 square-foot manufacturing space dedicated entirely to the production of face masks. Read More
The system, which has also been cleared in the U.S. and Europe, includes a medical device, smartphone app and a pelvic floor-muscle exercise database. Read More
The acquisition, expected to close in the late second quarter of the year, “aligns with Organon’s strategy to become a global leader in woman’s health by focusing our product development on her unmet medical needs,” Ali said. Read More
The company also received FDA clearance in April 2020 for AI technology that identifies intracranial hemorrhages and mass effect conditions that can cause injury to brain tissue. Read More
As part of postmarket surveillance, devicemakers should continuously monitor the performance of their devices, including for new potentially cross-reacting agents that could lead to inaccurate results, the group said. Read More
The problem is that high-risk breakthrough devices were approved largely on the basis of studies that used “short-term, surrogate endpoints for effectiveness, which may not translate into clinical benefits,” the researchers contend. Read More
RWD can be derived from electronic health records (EHRs), claims and administrative data, data from product and disease registries, patient-generated data, and device-generated data, the agency said. Read More
ResApp said it plans to explore the device’s capabilities and first intends to put the device through clinical trials to evaluate its ability to measure cough frequency. Read More