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The FDA granted breakthrough device designation and permitted marketing for the first in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease. Developed by Fujirebio Diagnostics, the Lumipulse G β-Amyloid Ratio test is intended for adults, aged 55 years and older, presenting with cognitive impairment who are being evaluated for AD and other
Xcardia Innovation Ltd., following the February FDA 510(k) clearance of its device for cardiac pacemaker and defibrillator lead extraction, announced the first-in-human use of the new device. According to a company press release, the new device (Xtractor) is designed with advanced controls, incorporating motor-assisted activation, steering capability, pedal activation and an advanced tip
The FDA cleared a new electrophysiology recording technology designed to improve signal acquisition and accuracy of electrogram interpretation in the diagnosis and treatment of complex atrial arrythmias, CathVision announced.The ECGenius EP Recording System includes EP recording technology and a proprietary hardware amplifier to acquire high-fidelity, low-noise, cardiac electrograms to help
Through 12 months, psilocybin-assisted treatment showed to be safe and effective for major depressive disorder, researchers reported in the Journal of Psychopharmacology. Natalie Gukasyan, MD, assistant professor of psychiatry and behavioral sciences at Johns Hopkins University in Baltimore, and colleagues conducted a randomized, waiting-list controlled study of 24 patients between the
TecTraum Inc. announced complete enrollment status for a clinical trial evaluating its pro2cool device, a noninvasive hypothermic therapy system for treating concussions. The device, designed to decrease the severity of concussion symptoms, provides localized cooling for the head and neck to lower blood temperature before reaching the brain, the company stated in a press release.