Guided Therapeutics Files Premarket Approval Application Clinical Report with FDA
Guided Therapeutics has filed the results of its multicenter clinical trial with the FDA as part of the Premarket Approval process for its LuViva Advanced Cervical Scan. The study demonstrated that LuViva detected 21 of the 32 disease cases missed by standard colposcopy-directed biopsy, increasing the overall detection rate from 68% to 89%.
Key figures
- P value
- < 0.0001
- Patients enrolled
- 480
- Patients completed
- 428
- Luviva detected missed
- 21
- Significant disease cases
- 99
- Detection rate with luviva
- 89%
- Missed by standard of care
- 32
- Detection rate standard of care
- 68%
AI analysis
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.