510(k)
23andMe Gains FDA Clearance for Direct-to-Consumer Prostate Cancer Genetic Risk Test
The firm is now authorized to sell a genetic health report on the HOXB13 marker that indicates risk for hereditary prostate cancer, its third DTC cancer risk report with 510(k) clearance.
Werfen POC Hemostasis System Obtains FDA 510(k) Clearance
The platform returns activated clotting time results in minutes and is currently in clinical use in multiple European countries.
Ortho Clinical Diagnostics, Siemens Healthineers, Roche, and Others Obtain FDA Clearances in October
The FDA granted clearance to Roche for use of its Cobas Cdiff nucleic acid test, which detects the toxin B gene running on the firm's Liat point-of-care instrument.
Clever Culture Systems Nabs FDA Clearance for Culture Screening Instrument With MRSA Samples
The instrument differentiates culture plates with significant bacterial growth that need further review from those with no significant growth.
OpGen Receives FDA Clearance for AMR Panel, Prelim Q3 Revenues Up 9 Percent
The firm's Acuitas AMR Gene Panel tests for 28 genetic AMR markers in isolated bacterial colonies from 26 different pathogens.