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.

Balt Extrusion SAS has received CE mark approval for its Silk Vista flow diverting stent for those with unruptured intracranial aneurysms. Flow diverters aim to divert blood flow away from an aneurysm, allowing it to heal and reducing the risk of rupture.

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.

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.