US health regulators make it easier to test for a common birth defect
What happened
The US Food and Drug Administration is making it easier to get approval for devices that detect cytomegalovirus (CMV) in newborns. This means more companies can bring these tests to market, which could make them more widely available.
Why it matters
CMV is a common virus that can cause serious health problems in babies, but it often goes undetected. For years, getting new diagnostic tests approved was a slow and expensive process. This change means companies can now get these tests approved faster and with less regulatory burden, which could lead to more widespread screening for CMV in newborns.
The signal
Watch for new CMV detection devices to appear on the market and whether states begin to adopt universal newborn screening for CMV.