Summary: The FDA has approved Avadel Pharmaceuticals’ LUMRYZ for pediatric patients aged 7 and older with narcolepsy, offering a once-nightly treatment for cataplexy and excessive daytime sleepiness. Key Takeaways: FDA Approval for Pediatric Use: LUMRYZ, previously approved for … [Read more...]
OrthoApnea NOA Reaches 450,000 Users Following FDA Approval
Summary: The OrthoApnea NOA, a 3D-printed nylon oral appliance approved by the FDA in 2021, has been utilized by over 450,000 patients for the treatment of mild to moderate obstructive sleep apnea (OSA) and snoring. Developed through a collaborative effort among biomedical … [Read more...]
Inspire Gains EU Approval for Full-Body MRI Scans
Summary: Inspire Medical Systems has received approval under the European Union Medical Device Regulation (EU MDR) for full-body MRI scans for patients using its Inspire therapy for obstructive sleep apnea. This approval, which expands the previous scan limitations, applies … [Read more...]