MedTech Dive March 18, 2025
The company plans to file the results with the FDA by mid-2025 and launch the product in 2026.
Dive Brief:
- Spectral AI’s Deepview System has outperformed burn physicians in identifying non-healing tissue, the company said Monday.
- Deepview achieved 86.6% sensitivity when identifying non-healing tissue at an image-wise level of assessment, while the clinical judgment annotation of burn physicians scored 40.8%. The study also conducted assessments at the pixel-wise level.
- BTIG analysts called the result a “major milestone” in a Monday note to investors. Spectral AI plans to file the results with the Food and Drug Administration by mid-2025 and launch the product in 2026.
Dive Insight:
Spectral AI’s system uses a physical device to capture images. The device...
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