Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
Indica Labs Nabs CE Mark for AI-Based Prostate Cancer Detection, Gleason Grading Tool
The prostate cancer screening tool is scanner agnostic and was trained using more than 870,000 training patches obtained from the annotation of digital scans.
Immunovia Receives Pennsylvania, Maryland Clinical Lab Permits
The company can now provide its ImmRay PanCan-d test to detect stage I and stage II pancreatic cancer in at-risk patients to clinicians in 48 states.
Luminex Obtains CE Marking for MDx Panel to Detect Flu A/B, RSV, COVID-19
Results are generated in a single workflow from a patient sample, which enables rapid detection for the differential diagnosis of a single pathogen.
Trinity Biotech Gets CE Mark for Rapid COVID-19 Antigen Test
The lateral flow test uses anterior nasal swab samples and provides results within 10 minutes, the Irish company said.
Nanomix Nabs CE Mark for Point-of-Care COVID-19 Antigen Test
The test uses a disposable microfluidic cartridge to detect the nucleocapsid antigen using the Nanomix eLab Analyzer and provides qualitative results in 15 minutes.