Clew Medical Ltd., of Netanya, Israel, has secured an emergency use authorization (EUA) from the U.S. FDA for its ClewICU system for use with COVID-19 patients in intensive care units (ICUs). The screening system is a standalone software as a medical device product that uses vital signs, laboratory data, medications and other information to assess the likelihood a patient has been infected with SARS-CoV-2, the virus that causes COVID-19. Read More
A wireless system to monitor mothers in labor and their fetuses has been introduced by Royal Philips NV in the U.S. Known as the Avalon CL Fetal and Maternal Pod and Patch, it is commercialized under recently updated guidance from the U.S. FDA. The Amsterdam-based company is continuing to pursue a standard 510(k) clearance for the system, which is marketed in European countries, Australia, New Zealand and Singapore. Read More
HONG KONG – China and U.S.-based Lisen Imprinting Diagnostics Inc. has unveiled its Quantitative Chromogenic Imprinted Gene In-Situ Hybridization (QCIGISH) technology, a novel approach for identifying, visualizing and quantifying the biallelic and multiallelic expressions of an imprinted gene panel associated with cancer status. Read More
PARIS – Agfa-Gevaert Group NV, of Mortsel, Belgium, has sold parts of its health care information technology (IT) business to Italy’s Dedalus Holding SpA for $1.1 billion. The divested interests include health care information solutions activities and integrated care activities in Germany, Austria, Switzerland, France and Brazil, as well as certain IT imaging activities in these territories. It represents about half of Agfa Healthcare’s business. Read More
The disconnect between the need for sleep and the possession of a brain is what prompted Dragana Rogulja, an assistant professor of neurobiology in the Blavatnik Institute at Harvard Medical School, and her team to take a look at multiple tissues in sleep-deprived flies and mice. Read More
New hires and promotions in the med-tech industry, including: Medit, Neuroone Medical Technologies, Ocutrx Vision Technologies, Renovacare, Tyto Care. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbott, Exact Sciences, Halo Diagnostics, Lucence, Medtronic, Sequana Medical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bimini Health Tech, Binx Health, Cardinal Health, Copan, Cymedica Orthopedics, Debiotech, Exthera, Genmark Diagnostics, Healeon Medical, Healgen, Hill-Rom, Inovalon, Kardiac Devices, Keystone Heart, Kore, MD Anderson Cancer Center, Menarini, Neokidney, Ngmedical, Nicoya, Philips, Puritan, Second Sight, Svenska Labfab, Trialspark, Venus Medtech, The Wound Pros. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clew, Guard Medical, Infinity, Inmode, Smith+Nephew. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Endologix, Klarity, Supernus, United Therapeutics. Read More
Keeping you up to date on recent developments in oncology, including: 3D-printed reservoir + magnetic sponge = new way to beat cancer; HRAS-driven translation helps skin prevent tumors; NETS and mets; Observational study supports cryoablation for RCC. Read More
