Shots:
- The US FDA has granted 510(k) clearance to Somnum V3.0, an AI-based clinical decision support software to assist medical professionals in analyzing polysomnography data, incl. sleep staging & respiratory event detection
- Somnum V3.0 automatically detects apnea & hypopnea events, & classifies them as obstructive, central, or mixed sleep apnea. Validation data submitted to the FDA showed >97% Overall Percent Agreement across respiratory event categories
- HoneyNaps is also developing additional digital biomarkers, incl. Hypoxic Burden, Arousal Burden, & Ventilatory Burden, to enable broader assessment of sleep apnea severity & health risks. It plans to pursue further FDA clearances for future SOMNUM versions
Ref: PRnewswire | Image: HoneyNaps | Press Release
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