Oxford, U.K.-based Perspectum Diagnostics Ltd. is recruiting patients for a study to determine the degree of damage sustained by major organs following infection with the SARS-CoV-2 virus. The company will use its multiparametric magnetic resonance imaging (MRI) devices and other means to evaluate post-COVID-19 organ damage, track healing and evaluate impact on survivors.
Cytovale Inc., a San Francisco-based medical technology company, has snagged an additional $3.83 million in funding from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) to conduct a pilot study of its Rapid Sepsis Diagnostic System for patients with potential respiratory infections, including SARS-CoV-2, the novel coronavirus responsible for COVID-19. The patented technology, which can diagnose sepsis in less than 10 minutes, could speed up triaging and treatment of critically ill patients suspected of having the life-threatening condition.
The role of diagnostic and surveillance testing in the COVID-19 pandemic is unquestionably critical, but the volume and type of tests needed to bring the economy back online is complex. Susan Van Meter, director of Advamed Dx, said on an April 22 press briefing that while molecular and serological tests will continue to play a vital role, “we’re going to see millions of antigen tests available in the coming weeks,” a development that will prove crucial in efforts to restore normal economic activity.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Predictive Technology Group, SC Worx, Spectrum DNA.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Life Spine, Mobidiag, Seegene.
Two phase III studies in China testing Gilead Sciences Inc.’s antiviral drug, remdesivir, in patients with COVID-19 infection have been halted after Chinese authorities reported a lack of eligible patients. Other studies, including trials sponsored by the Foster City, Calif.-based company, remain ongoing.
The U.S. FDA reported that it has expanded the emergency use authorization for the Labcorp polymerase chain reaction (PCR) test for SARS-CoV-2 to include the company’s Pixel self-collection kit, a development that may presage a wider testing paradigm that is needed to restore the U.S. economy to normalcy.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainlab, Inspire Medical Systems, Labcorp, Roche.
