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DELIVER topline results: Dapagliflozin reduces CV death, worsening HF in EF more than 40%

Topline findings from the phase 3 DELIVER trial show dapagliflozin significantly reduced risk for CV death or worsening HF compared with placebo in adults HF with mildly reduced or preserved ejection fraction, AstraZeneca announced.The trial of the SGLT2 inhibitor dapagliflozin (Farxiga) was conducted in more than 6,000 patients with HF with mildly reduced or preserved EF, defined as left
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Source: healio.com

Daycare, older siblings, preterm birth yield varied risks for childhood atopic diseases

Different age-specific patterns defined the relationships between early daycare, severe airway infection, preterm birth and atopy-related diseases in childhood, according to a study published in Pediatric Allergy and Immunology. These differences could be used to help identify strategies to prevent or delay atopic diseases, Tadao Nagasaki, of the department of respiratory medicine at the Graduate
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Source: healio.com

FDA permits marketing for new in vitro Alzheimer's disease test

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
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Source: healio.com

New device for lead extraction gets FDA clearance, first in-human use

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
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Source: healio.com

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FDA clears low-noise electrophysiology recording technology

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
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Source: healio.com

Psilocybin-assisted treatment for depression safe, effective through 12 months

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
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Source: healio.com

Medicare data: Long-term mortality, rehospitalization trends after acute MI improving

Rates for 10-year mortality and hospitalization for recurrence after an acute MI decreased steadily over more than 2 decades, though researchers observed marked inequities among subgroups. In an analysis assessing 25 years of Medicare data, researchers also observed marked differences in outcomes and temporal trends across demographic subgroups in the 30 days after an acute MI, emphasizing the
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Source: healio.com

Hypothermic therapy device shows promise in treating concussions

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.
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Source: healio.com

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