fda - Tech News from Simmons Systems (Page 2)

Tech News from Simmons Systems

fda

A collection of 31 posts

FDA Grants Emergency Authorization for Gilead's Remdesivir to Treat COVID-19

The Food and Drug Administration issues an emergency use authorization for Gilead Sciences' remdesivir, allowing doctors to administer the intravenous drug to hospitalized COVID-19 patients. Clinical data shows the treatment shortens patient recovery time by an average of four days.

FDA-Cleared AI Triage Tool Offered Free to Support Radiology Departments

Medical startup Nines provides its FDA-cleared AI triage software at no cost until June 30 to assist overwhelmed radiology departments during the COVID-19 pandemic. The tool automatically identifies potentially critical brain conditions on CT scans to help doctors prioritize urgent cases.

Abbott Receives FDA Approval for Five-Minute Coronavirus Test

Abbott wins emergency FDA authorization for a rapid molecular COVID-19 test that delivers positive results in just five minutes. The portable device allows testing outside traditional hospitals in clinics and physician offices.

Detroit Leads Nation With Rapid Five-Minute COVID-19 Test Deployment

Detroit becomes the first US city to deploy Abbott Labs' five-minute COVID-19 test, prioritizing local first responders. The mayor secures the machines directly to combat the city's severe outbreak.

FDA Approves 3D-Printed Splitting Device to Quadruple Ventilator Capacity

Prisma Health creates a free, 3D-printed ventilator connector that allows one machine to treat up to four COVID-19 patients simultaneously. The FDA grants emergency use authorization for this last-resort medical hardware as hospitals face severe equipment shortages.

Mojo Vision Promises AR Contact Lenses Despite Remaining Hurdles

Mojo Vision demonstrates impressive augmented reality capabilities for its smart contact lenses at CES, though the technology remains far from a finished consumer product. The company plans to initially launch the device as an FDA-recognized medical tool.

Cancer AI Startup Paige Secures $45M to Bring Diagnostic Tools to Market

Paige raises $45 million in new funding to advance its AI-driven cancer pathology platform toward FDA approval. The startup leverages a massive database of medical slides from Memorial Sloan Kettering to improve disease detection.

U.S. Researchers Test Brain Implants to Treat Severe Opioid Addiction

Medical researchers at West Virginia University are conducting the first U.S. clinical trial using deep brain simulation to combat treatment-resistant opioid addiction. The implanted device aims to monitor and curb addiction-related impulses in real time.

First Death Reported as CDC Investigates Mysterious Vaping-Related Lung Illness

Health officials are investigating nearly 200 cases of severe respiratory illness linked to e-cigarette use following the first reported death of an adult in Illinois. The CDC and FDA are currently gathering data to determine the exact cause of these unexplained pulmonary symptoms.

FDA Commissioner Scott Gottlieb Abruptly Resigns Amid Vaping Fight

FDA Commissioner Scott Gottlieb unexpectedly announces his resignation, leaving his post in one month to spend more time with his family. His sudden departure pauses his aggressive, unfinished campaign against underage e-cigarette use.

FDA Approves First Major Depression Drug in Over 30 Years

The FDA approves Johnson & Johnson's Spravato, an esketamine nasal spray for treatment-resistant depression. The fast-acting medication brings the first major breakthrough in depression treatment since the introduction of Prozac.

FDA Approves Esketamine Nasal Spray for Hard-to-Treat Depression

The FDA approves esketamine, a ketamine-related nasal spray, offering a fast-acting new option for patients with treatment-resistant depression. The Johnson & Johnson drug marks the first major depression treatment to reach the U.S. market in decades.

Alphabet's Verily Gains FDA Approval for Study Watch ECG Feature

Verily, Alphabet's life sciences arm, receives FDA clearance for an on-demand ECG feature on its clinical Study Watch. This milestone hints at potential health-tracking capabilities for future Google consumer wearables.

FDA Clears Verily's Prescription-Only ECG Smartwatch

The FDA clears Verily's Study Watch for on-demand ECG recording as a prescription-only medical device.

Withings Unveils Three-in-One Heart Monitor for At-Home Cardiovascular Care

Withings introduces the BPM Core, a $250 device that combines blood pressure monitoring, an ECG, and a digital stethoscope into a single arm cuff. The company seeks FDA approval for a Q2 release to help users easily detect heart conditions like AFib at home.