The American Journal of Managed Care

FDA Flags Administration Concerns for Aquestive's Noninvasive Epinephrine Film

Aquestive Therapeutics announced it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for Anaphylm (dibutepinephrine) Sublingual Film, a noninvasive ...
Nasdaq

Clinical Validation Study on Natera’s Fetal RhD NIPT Published in Obstetrics & Gynecology

Test demonstrated high performance metrics in largest study of its kind in the US with sensitivity of 100% and specificity of 99.3% Natera’s study is the largest clinical validation of a fetal RhD ...

AI tool can predict which trauma patients need blood transfusions before they reach the hospital

Severe bleeding is one of the most common and preventable causes of death after traumatic injury, yet currently available tools have poor ability to determine which patients urgently need blood ...
Nasdaq

Biodesix Announces Publication of Clinical Validation Study for Nodify CDT® Lung Nodule Test in CHEST Pulmonary Journal

Biodesix, Inc. announced a new study published in CHEST Pulmonary Journal reaffirming the effectiveness of its Nodify CDT® blood-based lung nodule test, which assesses seven autoantibodies linked to ...
Business Wire

Landmark Clinical Study Validates Patch-Based Onera Home-Polysomnography System in One of the Largest Sleep Diagnostic Trials of the Decade

Study demonstrates comparable performance between wireless, patch-based Onera Sleep Test System and in-lab polysomnography for sleep staging and respiratory event detection. EINDHOVEN, ...
ascopubs.org

Derivation and Validation of a Clinical Risk Assessment Model for Cancer-Associated Thrombosis in Two Unique US Health Care Systems

A Clinical-Genetic Risk Score for Predicting Cancer-Associated Venous Thromboembolism: A Development and Validation Study Involving Two Independent Prospective Cohorts Using retrospective data from ...
ascopubs.org

Identification and Validation of Prognostic Model for Tumor Microenvironment-Associated Genes in Bladder Cancer Based on Single-Cell RNA Sequencing Data Sets

Combined Transcriptome and Circulating Tumor DNA Longitudinal Biomarker Analysis Associates With Clinical Outcomes in Advanced Solid Tumors Treated With Pembrolizumab The prognostic model demonstrated ...

Panakeia publishes landmark clinical validation showing AI can deliver rapid molecular profiling for colorectal cancer

Panakeia publishes landmark clinical validation showing AI can deliver rapid molecular profiling for colorectal cancer Largest real-world, blinded, multi-site validation of AI molecular profiling from ...