Summary: OxiWear, a wearable health technology company, has received FDA clearance for its ear-worn pulse oximeter, a device designed for continuous, real-time monitoring of blood oxygen saturation and pulse rate. The device offers measurements during movement and across various … [Read more...]
Movano Continues to Pursue FDA Clearance for EvieMED Ring
Summary: Movano Health is working toward securing a 510(k) clearance from the FDA for its EvieMED Ring, a wearable device that combines medical functionality through pulse oximetry with wellness metrics related to sleep, activity, and mood/energy/symptom logging. After filing an … [Read more...]
DeltaWave Nasal Pillow CPAP Mask Receives FDA Clearance
Summary: REMSleep Holdings Inc has received FDA 510(K) clearance for its new DeltaWave nasal pillow CPAP interface mask. The DeltaWave is designed to enhance comfort and maintain natural breathing patterns, aiming to address common issues that lead to therapy discontinuation. The … [Read more...]
Australian-Designed Oral Appliance Gains FDA Clearance
Summary: GoodSleepCo, an Australian medical device company, has received FDA 510(k) clearance for its hushd Pro Avera oral appliance, which treats snoring and mild to moderate obstructive sleep apnea. Custom-made splints reposition the lower jaw to prevent airway blockage during … [Read more...]