The U.S. FDA has a number of draft guidances in queue thanks to the COVID-19 pandemic, but released two final guidances in mid-July, including the guidance for clinical investigations for prostate tissue ablation devices. Stakeholders pressed the agency to avoid a fixed period of follow-up for such studies due to variability in the elapsed time for device-related adverse events, but the agency stuck to the draft’s mandate for at least a year of follow-up.

Electrocore Inc. has snagged an emergency use authorization (EUA) from the U.S. FDA for use of its Gammacore Sapphire CV noninvasive vagus nerve stimulation (nVNS) to acutely treat asthma exacerbations in known or suspected COVID-19 patients. The hand-held therapy can be used at home and in a health care setting.

Infervision Technology Co. Ltd. has received the green light from the U.S. FDA for its Inferread Lung CT.AI product. The artificial intelligence- and deep learning-based technology automatically performs lung segmentation and identifies and labels different types of lung nodules. According to the 510(k) notification, Inferread Lung CT.AI “is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest on an asymptomatic population.”

The use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making may seem more aspirational than practical at times, but that state of affairs is changing rapidly. Wendy Rubenstein, director of personalized medicine at the U.S. FDA’s Center for Devices and Radiological Health, said contemporary versions of these real-world sources of evidence “are of progressively higher quality” in recent years, and thus RWE and RWD may soon hit their strides as mature sources of data with which regulators are increasingly comfortable.