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.

Plymouth, Minn.-based Nonin Medical Inc. gained a U.S. FDA 510(k) clearance for its Co-Pilot wireless hand-held multiparameter system (H500). The system is expected to be used by first responders to evaluate various oxygenation and respiratory-related parameters in patients after incidents such as cardiac arrest, traumatic injury, carbon monoxide or smoke inhalation.

The U.S. FDA’s priorities for testing for the SARS-CoV-2 virus have shifted as circumstances have changed, and the agency is putting more emphasis into testing of pooled samples. Toby Lowe, the associate director of the Office of In Vitro Diagnostics and Radiological Health (OIR), said on the July 8 diagnostic town hall that the agency wants to encourage test developers to work on their existing EUAs for pooled sampling.

Two subcommittees of the U.S. House Appropriations Committee have moved their respective appropriations proposals for the FDA and the NIH, restarting a process that has worked smoothly over the past couple of years. Still, Republicans in both committees objected to the use of emergency funding mechanisms in lieu of more routine appropriations.

The U.S. FDA held a July 7 webinar to go over a recent guidance on decontamination and bioburden reduction of N95 masks for the COVID-19 pandemic, and one of the take-away messages is that the agency is still quite concerned about the impact of residues left over from those processes, given that some of these residues can be inhaled by the wearer and trigger health problems of their own.

RapidAI, which focuses on imaging for stroke, has received the U.S. FDA’s nod for Rapid ASPECTS. According to the company, it is the first neuroimaging analysis device to gain clearance in the computer-assisted diagnostic software category.