The FDA approval process explained for drugs, devices and tests. What approval gives a company, what it does not, and the ASX record.

Let’s be honest: endometriosis has long been one of the most underdiagnosed and misunderstood medical conditions in women's health. A silent disruptor, it causes pain, fertility issues, and decades-long suffering, often without a name. Until now, the only path to a diagnosis was invasive laparoscopic surgery, usually after seven years of misdiagnosis. That’s not a system built for healing. But what if we could change that narrative with a simple blood test?