Summary: A study co-led by UCLA and Baylor College of Medicine suggests that a wearable transcutaneous electrical nerve stimulation (TENS) device may help alleviate persistent pain, fatigue, and mobility issues in individuals with long COVID. The device, which delivers … [Read more...]
Study Raises Concerns About Wi-Fi Device Radiation and Sleep Quality
Summary: A study suggests that exposure to radiofrequency electromagnetic fields from Wi-Fi-enabled devices, such as baby monitors, may contribute to sleep disturbances. Conducted in real-world conditions, the research found that participants exposed to the radiation experienced … [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...]
SOS Device Offers Sleep Monitoring and Emergency Alerts
Summary: Beyond Living has launched the AI SOS Device, a non-wearable, AI-driven solution designed to monitor vital signs during sleep. Paired with a sleep tracking belt, the device detects irregular heartbeats or breathing issues and sends real-time alerts to caregivers or … [Read more...]
Texas Surgeon Marks 100th Inspire Sleep Apnea Device Implant
Summary: David Cuthbertson, MD, at Covenant High Plains Surgery Center in Lubbock, Texas, recently completed his 100th implant of the Inspire device, a minimally invasive alternative treatment for sleep apnea patients who cannot tolerate CPAP therapy. The Inspire device, which is … [Read more...]
FDA-Cleared Head-Worn Device for Chronic Insomnia Launches
Summary: Neurovalens has launched Modius Sleep, an FDA-cleared, head-worn device designed to treat chronic insomnia through non-invasive electrical stimulation of the vestibular nerve. Used for 30 minutes each evening, it influences the brain areas regulating circadian rhythm to … [Read more...]
What Exactly Is Software as a Medical Device?
By Alyx Arnett Software is no longer just a tool in healthcare—it’s becoming a medical device in its own right. Known as software as a medical device, or SaMD, this technology is playing a growing role in diagnosing and treating conditions, with more companies, including those in … [Read more...]
‘ASV Is Not a Generic Device’
Interview by Sree Roy In 2015, the ResMed-funded SERVE-HF trial resulted in practice-changing guidance due to its shocking finding that a minute ventilation-triggered adaptive servo-ventilation (ASV) device increased the risk of mortality in people with central sleep apnea and … [Read more...]
Inspire Therapy Meets New EU Medical Device Standards
Summary: Inspire Medical Systems has achieved CE mark certification under the European Union’s updated Medical Device Regulation (EU MDR) for its sleep apnea treatment, Inspire therapy. This certification ensures compliance with the EU’s more stringent requirements, allowing … [Read more...]
Natus Appoints Veteran Medical Device Leader as New CEO
Summary: Natus has appointed Chris Landon as its new CEO. Landon brings over two decades of experience in the medical device industry, focusing on image-guided therapy devices, cardiology, and neurodiagnostics. He previously held executive roles at Philips and Medtronic and … [Read more...]