US health regulators clear a path for new ways to test for disease

US health regulators have created a new regulatory category for devices that preserve microbial DNA in patient samples. This means new diagnostic tests can now be approved more easily, speeding up their availability.

For years, new medical devices often faced a slow and expensive approval process, even for relatively simple technologies. This new classification means that devices designed to stabilize genetic material for testing will have a clearer, faster path to market. It makes it easier for companies to develop and sell tools that help doctors identify infections or diseases based on the genetic makeup of microbes.