FDA
Visby Medical Gains FDA 510(k) Clearance, CLIA Waiver for POC Respiratory Panel
The Visby Medical Respiratory Health Test is a disposable handheld RT-PCR-based assay for the detection and differentiation of SARS-CoV-2 and flu A/B.
Following pushback from industry stakeholders, the Trump administration appears to have reversed a number of the planned CDRH layoffs.
Abbott Receives FDA Clearance for Self-Collected STI Molecular Test
The device is intended for self-collection of samples in home settings and testing in a clinical laboratory.
Roche Lipoprotein (a) Test Receives FDA 510(k) Clearance
The test, which is intended for assessing cardiovascular risk, is the first lipoprotein (a), or Lp(a), test measured in nanomoles per liter to receive FDA clearance.
Doctors and patient advocates supporting pretreatment testing at times challenged FDA and other experts who aren't swayed by available evidence.