FDA tags Mallinckrodt’s one-way valve recall as Class I
The valves recalled are used in the INOmax Delivery system, which delivers nitric oxide therapy gas into the tubes between the ventilator and the patient’s breathing circuit. Image credit: Shutterstock/Jeppe Gustafsson. Mallinckrodt Manufacturing’s One-Way Valve 22F x 22M is on a one-way trip back to the company after the devices were found to not be […]
Signal: Roche to refile subcutaneous Tecentriq with FDA after UK approval
Roche has pushed back the launch of its subcutaneous Tecentriq to 2024. Photo: Qilai Shen/Bloomberg via Getty Images. Pharmaceuticals giant Roche reportedly plans to file a new application for subcutaneous oncology drug Tecentriq with the FDA by the end of the year. The news, ascribed to a company spokesperson by Endpoints News yesterday (12 September), […]
FDA approves CorVista’s medical device for cardiac disease
The non-invasive medical device system assists in the diagnosis of significant coronary artery disease. Credit: CorVista Health / Business Wire. The US Food and Drug Administration (FDA) has approved CorVista Health’s non-invasive medical device system with a CAD [coronary artery disease] Add-On option for detecting the presence of cardiac disease. Designed to assist in the […]
Binance Pay modernises healthcare payments with cryptocurrencies
The latest partnership between Binance Pay and Solve.Care will facilitate the use of over 70 cryptocurrencies for healthcare payments. Credit: Sener Dagasan/Shutterstock Cryptocurrency payment technology provider, Binance Pay and blockchain based healthcare relationship management platform, Solve.Care have announced a partnership to update healthcare payments and support the adoption of cryptocurrencies. The collaboration between the healthcare […]
Forum Health introduces Multifunction Cardiogram scan
The MCG scan can detect several cardiac abnormalities, such as microvascular disease, myocarditis and coronary artery disease. Credit: Ahmet Misirligul / Shutterstock.com. Forum Health Fond du Lac has introduced the new Multifunction Cardiogram (MCG) scan to identify the signs of heart disease at an earlier stage. Leveraging advanced artificial intelligence (AI) technology, the scan can detect […]
Mainz Biomed looks to expand cancer identification list for ColoAlert
ColoAlert demonstrated 94% sensitivity and 97% specificity to colorectal cancer and 81% sensitivity for detecting advanced adenoma. Image Credit: Orawan Pattarawimonchai / Shutterstock. Mainz Biomed has revealed clinical trial data for its colorectal cancer screening test, ColoAlert, showing high sensitivity for colorectal cancer and advanced adenoma. ColoAlert is an at-home diagnostic tool that can detect […]
Evolution begins DeCon device trial to assess vestibular disorders
The trial will compare the performance of the neuro-optical testing device with the videonystagmography technology. Credit: EVOLUTION OPTIKS LIMITED. Evolution Optiks has launched a prospective, single-site, randomised, controlled trial of its DeCon device to assess human vestibular disorders. It will compare the performance of the neuro-optical testing device with the videonystagmography technology. This technology is […]
Baylor Genetics launches Neurodevelopmental Disorders Panel
The new test is intended for children and other patients who may have autism spectrum disorder and intellectual disability. Credit: Ground Picture / Shutterstock.com. Baylor Genetics has introduced a new Neurodevelopmental Disorders Panel for the diagnosis of patients with intellectual disabilities or developmental delays. The new test is intended for children and other patients who […]
Forma Medical launch minimally invasive surgery procedure for hammer toe
Hammertoe is a condition that can occur when wearing small, narrow, tight shoes and if left untreated may require surgery. Credit: Catalina Villegas/Shutterstock US-based orthopaedic device manufacturer, Forma Medical has launched the first minimally invasive surgery (MIS) solution for hammer toe – OptimalHT. Hammer toe is a condition that causes the second, third or fourth […]
The freedom to experiment with coatings for medical devices
The freedom to experiment with medical devices coatings opens up the possibilities for solutions. Credit: asharkyu via Shutterstock. In the era of rapid medtech innovation, the demand for smarter and more resilient medical devices requires more advanced types of coatings. In a report by GlobalData, Thematic Intelligence Predictions 2023, in-vitro diagnostics and cardiovascular devices are […]