Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cirrusdx, Curative, Vent Multiplexor.
A recent Senate hearing raised the question of whether privacy and confidentiality are at risk when software is installed in smart devices for disease surveillance purposes, but there may be no absolute guarantee of confidentiality, jeopardizing the goodwill of citizens who are wary of big government.
Despite challenges associated with the ongoing COVID-19 pandemic, Abbott Laboratories saw its first-quarter revenue beating expectations, coming in at $7.73 billion vs. an expected $7.44 billion. Cowen’s Josh Jennings highlighted this result, adding in a note that while there are challenges for nondiabetes medical devices and core diagnostics, areas including diabetes, nutrition, the established pharmaceuticals division and COVID-19 testing shined.
An April 15 U.S. FDA stakeholder call revisited several themes of interest in connection with diagnostics for the COVID-19 pandemic. However, Tim Stenzel, director of the agency’s Office of In Vitro Diagnostics and Radiological Health, said that while the agency has not yet authorized a home sample collection kit, “we do think it’s going to happen very soon.”
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Behold.ai, Chembio, Nova Biomedical, Ortho.
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.
