Showing 1181-1190 of 2689 results for "".
- FDA Clears Wearable Ring Device that Monitors Sleep Quality and Health Datahttps://practicalneurology.com/news/fda-clears-wearable-ring-device-that-monitors-sleep-quality-and-health-data/2470610/The Food and Drug Administration (FDA) has granted 510(k) clearance for the Happy Ring Health Monitoring System (Happy Health, Austin, TX), a ring-shaped device worn on the finger that monitors biometric health data useful for care coordination for sleep apnea and other conditions. The health met
- New FDA-Cleared Software Update Enhances MRI Analysis for ARIA Detectionhttps://practicalneurology.com/news/new-fda-cleared-software-update-enhances-mri-analysis-for-aria-detection/2470568/NeuroQuant v5.0 (Cortechs.ai, San Diego, CA), the latest update to NeuroQuant (Cortechs.ai, San Diego, CA) neuroimaging analysis software, has received Food and Drug Administration (FDA) 510(k) clearance. The update enables the identification and evaluation of focal brain lesions in MRI images, w
- Wearable Chest Sleep Apnea Test Receives FDA Clearancehttps://practicalneurology.com/news/wearable-chest-sleep-apnea-test-receives-fda-clearance/2470557/The Food and Drug Administration (FDA) has granted 510(k) clearance to SANSA (Huxley Medical, Atlanta, GA), a sleep apnea patch that is worn on the chest. SANSA is an at-home, single-point-of-contact diagnostic device that does not require additional attachments such as belts, wires, or hoses. Th
- FDA Clears Dedicated Brain PET Imaging Devicehttps://practicalneurology.com/news/fda-clears-dedicated-brain-pet-imaging-device/2470533/The Food and Drug Administration (FDA) has granted 510(k) clearance to NeuroLF (Positrigo, Zurich, Switzerland), a compact PET imaging device specifically designed for the brain, which assists in the evaluation and monitoring of neurologic conditions. including, among others, Alzheimer disease (A
- Headset for EEG-Assessment of Seizure Activity Cleared by FDAhttps://practicalneurology.com/news/headset-for-eeg-assessment-of-seizure-activity-cleared-by-fda/2470494/The Food and Drug Administration (FDA) has granted 510(k) clearance to ONE (Zeto, Santa Clara, CA), a headset that records electroencephalography (EEG) signals and other patient data using artificial-intelligence (AI)–based triage tools to monitor seizure activity in critical or emergency c
- RapidAI Secures Clearance for Angioflow Perfusion Imaging Analysis Software for Stroke Assessmenthttps://practicalneurology.com/news/rapidai-secures-clearance-for-perfusion-imaging-in-the-angiography-suite-for-stroke-assessment/2470470/RapidAI (Menlo Park, CA), a developer of clinical decision support and patient workflow solutions using artificial intelligence for neurovascular and vascular care, announced that the Food and Drug Administration (FDA) has granted 510(k) clearance for its AngioFlow solution. AngioFlow is des
- Abbott’s Portable Whole Blood Test for TBI Cleared by FDAhttps://practicalneurology.com/news/abbotts-portable-whole-blood-test-for-tbi-cleared-by-fda/2470440/Abbott (Chicago, IL) announced that the FDA has granted 510(k) clearance to the i-STAT TBI cartridge. The portable i-STAT TBI cartridge system enables whole blood testing for suspected traumatic brain injury (TBI), providing lab-quality results to physicians within 15 minutes. The device, which i
- Avicenna.AI’s Stroke Severity Assessment Tool Receives FDA Clearancehttps://practicalneurology.com/news/avicennaais-stroke-severity-assessment-tool-receives-fda-clearance/2470435/Avicenna.AI (La Ciotat, France) announced that it received FDA 510(k) clearance for Cina-ASPECTS, an artificial intelligence (AI) tool that provides automatic assessment of stroke severity. Cina-ASPECTS automatically processes noncontrast CT scans and calculates ASPECTS (Alberta Stroke Program Ea
- FDA Clears Wearable Electrophysiological Monitoring Patch to Record EEG, EOG, EMG, and EKG Datahttps://practicalneurology.com/news/fda-clears-wearable-electrophysiological-monitoring-patch-to-measure-eeg-eog-emg-and-ekg-signals/2470409/The Food and Drug Administration (FDA) has granted 510(k) clearance to Smart Skin (X-trodes System M; X-trodes, Tel Aviv, Israel). Smart Skin is a wireless wearable system for medical-grade electrophysiological monitoring for at-home use, available as a dry-printed multi-modal electrode patch. Th
- Viz.ai's Intracerebral Hemorrhage Algorithm Gains FDA Clearancehttps://practicalneurology.com/news/vizais-intracerebral-hemorrhage-algorithm-gains-fda-clearance-1/2470404/Viz.ai has announced the FDA 510(k) clearance of its new algorithm for intracranial hemorrhage (ICH) detection and care coordination, called Viz ICH Plus. The software is intended to automate identification, labeling, and qualifying the volume of segmentable brain structures on non-cont