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FDA Issues Guidance for Opioid Therapy Device Trials

Ambulance at night

The U.S. Food and Drug Administration issued new regulatory guidance for clinical trials of medical devices designed to prevent or treat opioid use disorder. . . . → Read More: FDA Issues Guidance for Opioid Therapy Device Trials

NIH Funds Depression Game Therapy Clinical Trial

Brain activity graphic

A treatment for depression designed as a game for patients will be assessed in a clinical trial conducted by a university psychology lab and funded by National Institutes of Health. . . . → Read More: NIH Funds Depression Game Therapy Clinical Trial

Small Biz Award to Boost Maternal Health App

Pregnant woman torso, side view

A digital health company with an app for monitoring maternal health is receiving nearly $1 million to add an algorithm for detecting a dangerous pregnancy complication. . . . → Read More: Small Biz Award to Boost Maternal Health App

NIH Funding Single Home Test for Covid-19, Influenza, RSV

Co-Dx PCR Home test

A developer of diagnostics for infectious and other diseases is receiving a National Institutes of Health contract to advance a single at-home test for multiple respiratory diseases. . . . → Read More: NIH Funding Single Home Test for Covid-19, Influenza, RSV

Trial Underway Testing Dried Plasma for Transfusions

Donated plasma

A clinical trial is recruiting participants to assess the safety and feasibility of a system for spray drying and re-constituting a person’s blood plasma. . . . → Read More: Trial Underway Testing Dried Plasma for Transfusions

Digital Biomarkers Shown to Highlight Parkinson’s Disease

MRI image of white matter fibers in the brain

Early findings indicate calculations from MRI scans of white matter lesions in the brain can distinguish between Parkinson’s disease and other neurological conditions. . . . → Read More: Digital Biomarkers Shown to Highlight Parkinson’s Disease

Biochip Device Tests Malaria Drug Efficacy, Safety

Malaria model chip device

A lab-on-a-chip device with human organ cells is shown in lab tests to distinguish between malaria strains and detect drug toxicity when assessing blood for seven days. . . . → Read More: Biochip Device Tests Malaria Drug Efficacy, Safety

Insurance Barriers, Migraine Hospital Visits Linked

Hands covering face

A review of insurance claims shows patients facing obstacles to coverage for their migraine therapies are also more likely to need emergency care for treatment. . . . → Read More: Insurance Barriers, Migraine Hospital Visits Linked

Neuro Biomarkers, Home EEG Assessed in Upcoming Trial

brain stimulation graphic

A digital biomarkers company and developer of neuroscience analytics are collaborating on a study of EEG measurements and algorithms with a wearable device at home. . . . → Read More: Neuro Biomarkers, Home EEG Assessed in Upcoming Trial

Device Company, Medical Center Partner on Blood Infections Trial

Pseudomonas aeruginosa

A developer of detection systems for infections and university medical center plan a clinical trial to evaluate a sepsis device for helping patients with blood stream infections. . . . → Read More: Device Company, Medical Center Partner on Blood Infections Trial