Summary:The FDA has granted 510(k) clearance for Nonin Medical’s TruO2 OTC fingertip pulse oximeter, a medical-grade device designed for accurate blood oxygen readings across all skin tones. This clearance addresses concerns about disparities in pulse oximetry accuracy, … [Read more...]
FDA Pilot Aims to Improve Timeliness of Medical Device Recall Alerts
Summary: The FDA’s Center for Devices and Radiological Health (CDRH) has announced a pilot program to improve the timeliness of public communications about potentially high-risk medical device recalls or corrections. The initiative focuses on providing early alerts for issues … [Read more...]
Movano Focuses on EvieMED Ring FDA Review and New B2B Partnerships
Summary: In its Q3 2024 report, Movano Health outlined key business updates, highlighting the relaunch of the Evie Ring for direct-to-consumer sales and ongoing efforts to secure FDA 510(k) clearance for the EvieMED Ring. The company says it remains focused on expanding … [Read more...]
Tonix Seeks FDA Approval for Sleep-Enhancing Drug for Fibromyalgia
Summary: Tonix Pharmaceuticals has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for TNX-102 SL, a once-daily sublingual tablet designed to improve sleep, reduce pain, and alleviate other symptoms in fibromyalgia patients. The submission is … [Read more...]
Movano Provides Update on EvieMED Ring’s FDA Review Process
Summary: Movano Health has submitted a complete response to the FDA as part of the final review phase of its 510(k) application for the EvieMED Ring, a wearable device that combines medical functionality, such as pulse oximetry, with wellness tracking features. Movano remains … [Read more...]
FDA Expands Approval of LUMRYZ for Pediatric Narcolepsy
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...]
FDA Seeks Additional Information on Movano Health’s EvieMED Ring
Summary: Movano Health, which is pursuing FDA clearance for its EvieMED Ring, recently received additional clarifying questions from the FDA regarding the medical aspects of the device. This marks the final phase of the company’s 510(k) application review process. Movano says it … [Read more...]
Happy Health Smart Ring Earns FDA Clearance
Summary: Happy Health has earned FDA clearance for its Happy Ring, a clinical-grade smart ring designed to monitor key health metrics, including sleep, heart rate, and brain activity. The ring forms part of Happy Health’s at-home health monitoring platform, which integrates … [Read more...]
FDA Clears Sleep Apnea Oral Appliance for Bruxism Therapy Too
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...]
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