Summary: The Slow Wave DS8 oral appliance, initially FDA-cleared for mild to moderate OSA, has now received clearance for the treatment of sleep bruxism. Marketed as BROSA for bruxism, the device offers a comprehensive solution for both conditions by relaxing jaw muscles and … [Read more...]
FDA Warns Against Use of SnoreStop Nasal Spray Due to Contamination Risk
Summary: The FDA has issued a warning against using SnoreStop Nasal Spray, distributed by Green Pharmaceuticals, due to microbial contamination found in the product. Despite FDA recommendations for a recall on multiple occasions, the manufacturer has not complied. The … [Read more...]
FDA Clears Under-Mattress Mat for Home Sleep Apnea Screening
Summary: The US FDA has granted 510(k) clearance to a contactless, under-the-mattress device designed to aid in the diagnosis of obstructive sleep apnea (OSA). The device is clinically validated for home screening, using sensors to monitor sleep, breathing, and cardiovascular … [Read more...]
FDA Review of Movano Health’s EvieMED Ring Advances
Summary: Movano Health had an in-person meeting with the US Food and Drug Administration (FDA) on Aug 15 to discuss the wellness features of its EvieMED Ring. The meeting resulted in the advancement of the review process for the device, which includes both medical and wellness … [Read more...]
OxiWear Gets FDA Clearance for Ear-Worn Pulse Oximeter
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...]
FDA Clears Prescription Digital Insomnia Therapeutic SleepioRx
Summary: The US Food and Drug Administration (FDA) has cleared SleepioRx, a digital therapeutic developed by Big Health for the treatment of chronic insomnia. SleepioRx employs cognitive behavioral therapy for insomnia (CBT-I) to address the cognitive and behavioral factors that … [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...]
FDA Seeks Input on Advancing Health Equity in Medical Devices
Summary: The FDA’s Center for Devices and Radiological Health (CDRH) has published a discussion paper titled “Health Equity for Medical Devices” and is seeking public input to advance health equity in the medical device sector. The paper outlines considerations for designing … [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...]
FDA Approves Next-Gen Inspire Therapy System for OSA
Summary: Inspire Medical Systems announced it has received FDA approval for its next-generation Inspire V therapy system, which includes a new neurostimulator and Bluetooth-enabled patient remote and physician programmer. The company is preparing for a commercial launch in the … [Read more...]