Swedish neurotech startup Flow Neuroscience has secured FDA approval for the first brain stimulation device for home use in ...

MDR, MDSAP, and FDA audits demand rigorous preparation, lifecycle traceability, and risk-based compliance for global market ...

Shape’s CE mark under the EU MDR encompasses its Impede and Impede-FX embolisation plugs and Impede RapidFill delivery ...

Shape Memory Medical Inc., innovator of the proprietary shape memory polymer technology for endovascular applications, announced that its IMPEDE® Embolization Plug product family has received ...

Shape Memory Medical Inc., innovator of the proprietary shape memory polymer technology for endovascular applications, announced that its IMPEDE Embolization Plug product family has received certifica ...

Dec 11 (Reuters) - The U.S. Food and Drug Administration has approved Flow Neuroscience's at-home brain stimulation device to treat depression, offering an alternative to typical antidepressants that ...

The FDA has approved its first at-home, nondrug therapy for depression, with a wearable brain stimulation headset developed by Flow Neuroscience. The agency issued a green light that covers the device ...

Version 4 of the Manual on Borderline and Classification for Medical Devices was published in September by the European Commission’s Medical Device Coordination Group. Our Life Sciences Regulatory ...

In recent years, there has been a growing trend in wearable technology: trackers that look like a fashion accessory and yet are smart enough to help us understand our bodies better. If you’ve ever ...

Sony senior manager of product management Takuro Fushimi in an interview with TechRadar the PlayStation Portal is now the most used device for PlayStation 5 Remote Play. "Our data shows that ...