HoneyNaps Secures FDA Clearance for AI Sleep Diagnostic Software Somnum V3.0

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 Related News: ElectroWire Medical Secures FDA 510(k) Clearance for LightningWire Transseptal System PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us atconnect@pharmashots.com The post HoneyNaps Secures FDA Clearance for AI Sleep Diagnostic Software Somnum V3.0 appeared first on PharmaShots.