March 15, 2024
Via: Medical Device NetworkBecton, Dickinson and Company (BD) has partnered with Poland’s non-governmental non-profit organisation The Great Orchestra of Christmas Charity (GOCC) to expand testing for bloodstream infections (BSIs) and sepsis management in the country. The collaboration aims to provide more than 150 […]
March 14, 2024
Via: Medical Device NetworkManchester University NHS Foundation Trust (MFT) in the UK has announced that its blood test could benefit thousands of women eligible for preventative breast cancer drugs. This highly sensitive hormone test can determine the effectiveness of anastrozole, a drug recommended […]
February 2, 2024
Via: Medical Device NetworkThe US Food and Drug Administration (FDA) has granted clearance for Hologic’s new Genius Digital Diagnostics System with the Genius Cervical AI algorithm for cervical cancer screening. This system is claimed to be the first FDA-cleared digital cytology platform that […]
January 30, 2024
Via: Medical Device NetworkResearchers at OU Health Stephenson Cancer Center in Oklahoma, US, are initiating a study that could transform pancreatic cancer detection using MSOT imaging. This new imaging technique, combined with a specially designed contrast agent, has the potential to identify cancer […]
January 23, 2024
Via: Medical Device NetworkCognito Therapeutics has enrolled the first patient in a biomarker substudy within its HOPE pivotal trial evaluating sensory stimulation device in Alzheimer’s disease patients. The HOPE study (NCT05637801) is assessing the efficacy of Cognitio’s GammaSense Stimulation system in subjects with […]
January 22, 2024
Via: Medical Device NetworkThe National Health Service (NHS) in the UK has introduced a ‘blood matching’ genetic test, marking a global first in personalised healthcare for patients with sickle cell disorder and thalassaemia. This new blood group genotyping test is expected to benefit […]
January 12, 2024
Via: HuffPostWhen you have a COVID-19 infection, you’re told to isolate and stay away from others until you’re better. But while many folks do improve at home thanks to a combination of medication, rest, hydration and time, others require additional medical […]
January 4, 2024
Via: Medical Device NetworkThe US Food and Drug Administration (FDA) has granted breakthrough device designation to CanScan, the multi-cancer early detection solution by Canadian medtech Geneseeq. CanScan was built using Geneseeq’s highly sensitive MERCURY multi-omics technology. The solution uses low-depth whole-genome sequencing (WGS) […]
January 3, 2024
Via: Medical Device NetworkDaxor Corporation is seeking approval from the US Food and Drug Administration (FDA) for its next-generation blood volume analyser, Daxor BVA. Daxor BVA is designed for rapid, simple, and bedside patient care. The company submitted to the FDA through the […]
December 28, 2023
Via: Medical Device NetworkMolecular diagnostics company Co-Diagnostics (Co-Dx) has sought emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its Co-Dx PCR Covid-19 test with Co-Dx PCR Pro instrument. Co-Dx’s submission for review by the FDA includes the PCR […]
December 11, 2023
Via: Medical Device NetworkThe Illinois Public Health Association (IPHA) in the US has received grant funding from cancer screening and diagnostic tests provider Exact Sciences to improve colorectal cancer screening rates. The funds will be used to support screening and provide more healthcare […]
December 5, 2023
Via: Fox NewsCould a simple blood test detect Alzheimer’s disease years before symptoms appear? New research from Resonant, a Utah biotech company that develops diagnostic tests for neurodegenerative diseases, suggests it may be possible. Researchers said its new test achieved 100% accuracy […]
December 1, 2023
Via: Medical Device NetworkThe landscape of laboratory-developed tests (LDTs) is facing a significant regulatory shift as the US Food and Drug Administration (FDA) proposes to regulate them as medical devices. The new proposed rule published in October 2023 states the FDA’s intention to […]
November 2, 2023
Via: Fox NewsThe American Cancer Society (ACS) has announced new guidelines for lung cancer screenings. Published in the ACS journal “CA: A Cancer Journal for Clinicians” on Wednesday, the advisory reconsiders those who are at high risk for developing lung cancer and […]
October 30, 2023
Via: Medical Device NetworkUpfront Diagnostics has embarked on the final phase of clinical trials in UK hospitals evaluating the use of its point-of-care rapid blood test for stroke. The clinical study is being led by the Newcastle University Stroke Research Group in the […]
October 26, 2023
Via: HitConsultantWe are living in a mental health epidemic. An estimated 26 percent of Americans ages 18 and older – about one in four adults – suffer from a diagnosable mental disorder in a given year. Among mental disorders, cases of […]
October 18, 2023
Via: HuffPostIt’s that time of year again. Upper respiratory infections like respiratory syncytial virus (RSV), influenza and COVID are rising — and we’re only just getting started. The signs and symptoms of these infections can be quite similar and include anything […]
October 12, 2023
Via: Medical Device NetworkShanghai Kehua Bio-engineering (KHB) has obtained an EU class D in vitro diagnostic regulation certification for rapid tests covering the company’s diagnostic kit for HIV (1/2) antibody (Colloidal Gold) V2. KHB’s HIV diagnostic kit tests for human immunodeficiency virus (HIV)-1 […]
October 9, 2023
Via: Medical Device NetworkAs the prevalence of neurodegenerative diseases rapidly rises, researchers at the ongoing HLTH 2023 conference highlighted how biomarker development is urgently needed for treatment breakthroughs to occur. In the United States, as many as 6.2 million people may have Alzheimer’s […]
August 11, 2023
Via: Kaiser Health NewsBy summer 2021, Gilbert Milam Jr. was living a good life. A nationally renowned rapper who performs under the name Berner, Milam was also enjoying the global expansion of Cookies, a brand of cannabis products and clothing that he co-founded […]