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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 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
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
The device is implanted through a vein in the groin or neck into the right side of the heart and then into the RVOT, using a thin, hollow catheter with a collapsed Harmony valve on the end. Read More