The FDA’s weekly town hall on testing for the COVID-19 pandemic included the usual range of concerns about test performance, but concerns regarding swabs and sample sites continue to mount. The predicament has led to the announcement that the FDA along with the National Institutes of Health (NIH) will hold a May 15 town hall regarding swabs, with a particular interest in swabs produced via additive manufacturing.
The U.S. FDA has granted emergency use authorization (EUA) to New Haven, Conn., startup Vent Multiplexor LLC for its emergency rescue co-ventilation device. Developed in collaboration with Yale New Haven Hospital, the Vent Multiplexor enables individualized mechanical ventilation of two adults on a single ventilator – lessening demand for more critical care machines in the ongoing COVID-19 outbreak.
As health care workers face critical shortages of personal protective equipment (PPE) to deal with the COVID-19 crisis, 3D printing companies, medical device manufacturers and other organizations are stepping up to produce face shields, ventilators and other needed supplies. For its part, Rehovot, Israel-based Stratasys Ltd. has assembled a coalition of more than 150 companies and universities to produce 3D-printed visors and clear plastic face shields. The coalition aims to produce up to 16,000 face shields per week by the end of next week.