The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA warning letter to company promoting test kits.
Varian Medical Systems Inc. has invested $10 million in and inked a collaboration agreement with Cota Inc., a Boston-based curator of oncology clinical data. The radiation oncology company will now offer its customers access to Cota’s oncology real-world analytics and data curation services, which aggregate electronic health record (EHR) data to yield meaningful insights.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Angiocrine, Bioxcel, Gyroscope, Inventiva, Sebela, Sorrento, Surface.
As cases skyrocket and more questions arise about the high rate of false negatives returned by rapid testing in COVID-19 cases, a simple, new diagnostic test offers far greater accuracy. Researchers around the globe have found that artificial intelligence can detect coronavirus infections in recorded forced coughs, with nearly 100% accuracy in asymptomatic or presymptomatic cases, making it an ideal quick screening test. Forced cough or voice analysis shows strong results in other conditions, too, including pulmonary hypertension and, surprisingly, Alzheimer's disease.
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