MedTech News

New 4D brain map reveals potential early warning signs of multiple sclerosis

Using an animal model of multiple sclerosis (MS), researchers at the National Institutes of Health (NIH) have created a four-dimensional brain map that reveals how lesions similar to those seen in human MS form. These findings, published in Science, provide a window into the early disease state and could help identify potential targets for MS treatments and brain tissue repair.

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Can a smartwatch save your life? Google researchers develop smartwatch algorithm to detect cardiac arrest

A machine learning algorithm running on a smartwatch demonstrated the ability to detect sudden loss of pulse with high specificity (99.99%) and moderate sensitivity (67.23%), according to a study led by Google Research. Designed to identify cardiac arrest events, the system can automatically place an emergency call when it senses an event has occurred, even if the user is unresponsive.

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Visby Medical™ Receives FDA Clearance and CLIA Waiver for Point-of-Care Respiratory Health Test

SAN JOSE, Calif., Feb. 26, 2025 /PRNewswire/ — Visby Medical™ announced today that it has received 510(k) clearance and was granted a CLIA waiver from the U.S. Food and Drug Administration (FDA) for its point-of-care respiratory health test. The Visby Medical Respiratory Health Test is a rapid polymerase chain reaction (PCR) test that detects and differentiates between upper respiratory infections caused by influenza (Flu) A & B, and SARS-CoV-2 (COVID-19). This multiplexed molecular device is the first handheld test to receive this designation after being granted Emergency Use Authorization (EUA) in December 2022.

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Sway Medical, Inc. Announces FDA 510(k) Clearance of its Comprehensive Concussion Management System

TULSA, Okla., Feb. 26, 2025 /PRNewswire/ — Sway Medical, Inc., the company that created the Mobile Concussion Management category, is proud to announce that it has received FDA 510(k) clearance as a Computerized Cognitive Assessment Aid for Concussion under Section 882.1471. This clearance expands on Sway Medical’s previous FDA clearance for balance testing in head injuries, officially recognizing Sway as the first fully integrated tool that combines both cognitive and balance testing into one product for concussion management.

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