The tool helps healthcare professionals identify different types of sleep-disordered breathing through automated data analysis.
RT’s Three Key Takeaways:
- FDA Clearance: HoneyNaps received USFDA 510(k) clearance for its Somnum V3.0 software designed to analyze sleep data.
- Automated Classification: The Ai-based tool automatically detects and classifies obstructive, central, and mixed sleep apnea with a reported 97% agreement rate.
- Future Biomarkers: The company plans to integrate additional markers such as hypoxic, arousal, and ventilatory burden into future versions of the platform.
The USFDA granted 510(k) clearance for the HoneyNaps Somnum V3.0 Ai-based software for polysomnography (PSG) analysis, according to the company.
The clinical decision support software is designed to assist healthcare professionals in analyzing PSG data, including sleep staging and respiratory event detection. The latest clearance expands the software’s capabilities for automated analysis of sleep-disordered breathing, the company said in a news release.
Somnum V3.0 uses Ai algorithms to detect apnea and hypopnea events. It classifies apnea into obstructive sleep apnea (OSA), central sleep apnea (CSA), and mixed sleep apnea (MSA). Unlike conventional approaches that primarily assess sleep-disordered breathing using composite indices, the software provides event-level classification to support clinical scoring.
Validation results submitted as part of the FDA clearance process showed the algorithms achieved an overall percent agreement of more than 97% across respiratory event categories, according to the news release.
By analyzing physiological patterns from multi-channel biosignals, the software is designed to distinguish different apnea subtypes that may be challenging to differentiate through manual scoring alone. The company said in a news release that this capability may support more accurate assessment of sleep-disordered breathing severity and assist clinicians in treatment planning.
“The FDA 510(k) clearance for Somnum V3.0 represents regulatory validation of our Ai algorithm’s clinical performance in automatically detecting and differentiating OSA, CSA, and MSA,” said Sean Ha, president of HoneyNaps USA, in a news release.
The company is also developing next-generation Ai technologies and digital biomarkers, including hypoxic burden, arousal burden, and ventilatory burden, to enable evaluation of disease severity and healthcare risks associated with sleep apnea. HoneyNaps plans to pursue additional FDA 510(k) clearances for future versions of the software incorporating these capabilities, according to the news release.
