Siemens Healthineers (ETR: SHL) announced today that it has secured an FDA emergency use authorization for its COVID-19 antibody test. The news comes nearly a week after the German medtech giant said it had started worldwide shipments of the test — a laboratory-based total antibody test that can detect SARS-CoV-2 antibodies including IgM and IgG in blood. […]
Siemens Healthineers to produce 50m antibody tests per month against COVID-19
Siemens Healthineers (ETR: SHL) said today that it has started worldwide shipments of its COVID-19 antibody test, with a goal of producing 50 million tests per month as the pandemic evolves. The German medtech giant also announced that FDA has granted an emergency use authorization for its PCR Fast Track Diagnostics (FTD) SARS-CoV-2 Assay6 test kit. Both […]
Siemens Healthineers seeking EUA for its coronavirus test kit
Siemens Healthineers (ETR: SHL) announced today that it is making its Fast Track Diagnostics (FTD) test kit for COVID-19 available as it seeks FDA emergency use authorization (EUA) and other forms of regulatory approval. The FTD SARS-CoV-2 assay kit is designed to diagnose infection by the SARS-CoV-2 virus that causes coronavirus. Siemens Healthineers is already shipping test […]
FDA clears Siemens Healthineers blood analyzer
Siemens Healthineers (ETR: SHL) announced today that it won FDA clearance for its RapidPoint 500e blood gas analyzer for diagnosing and monitoring people in the intensive care unit, operating room or emergency room. RapidPoint 500e is designed to generate blood gas, electrolyte, metabolite, CO-oximetry and neonatal bilirubin results that are then used to diagnose and […]
RaySearch Labs issues urgent field safety notice for certain RayStations
RaySearch Laboratories issued an urgent field safety notice in Europe to warn on an issue with the dose calculation for the Siemens (NYSE:SI) virtual wedge in several of RaySearch’s RayStation treatment planning systems. The affected RayStation models listed in the safety notice out of Germany included RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), […]
Report: Mayo Clinic to try Corindus telestenting
Mayo Clinic researchers this spring plan to try out Corindus’ telestenting technology — which Mayo officials think could improve care in the rural hospitals in their network, according to a report in the Star Tribune of Minneapolis. Corindus told MassDevice‘s sister site Medical Design & Outsourcing in 2018 that the company had a partnership with […]
Fujifilm to acquire Hitachi’s medical imaging biz for $1.56 billion
Fujifilm (TSE:4901) announced today that it plans to buy Hitachi’s (NYSE:HIT) medical imaging business for about $1.56 billion. The boards of both companies are scheduled to vote on the acquisition today. The deal could improve Fujifilm’s ability to compete globally against medical imaging giants GE Healthcare (NYSE:GE), Philips (NYSE:PHG), Siemens (NYSE:SI) and Canon (NYSE:CAJ). GE, […]
Siemens Healthineers unveils new CT scanner
Siemens (NYSE:SI) Healthineers announced that it won FDA clearance for its Somatom X.cite premium single-source computed tomography (CT) scanner with the myExam Companion user interface concept. The myExam Companion user interface is designed to guide the user through the exam workflow with precise questions about the patient, enabling optimization of the Somatom X.cite’s state-of-the-art features, according […]
Report: Imaging industry put $9m into pushing 3D mammograms despite lack of evidence
Companies that make 3D mammography equipment have spent millions on marketing the devices, even though scientific evidence of their superiority to traditional mammography is lacking, according to a new report. The report by Kaiser Health News says that Hologic (NSDQ:HOLX), GE Healthcare (NYSE:GE), Siemens Healthineers and Fujifilm (TSE:4901) have paid doctors and teaching hospitals a collective $9.2 […]
This low-magnetic MRI field produces clear images of the lungs
Researchers at the National Institutes of Health and Siemens developed a low magnetic-field MRI system to improve imaging of the lungs. The high-performance, low magnetic-field MRI system is designed to improve the image quality of the lungs and other internal structures. It is also designed for patients who have pacemakers and defibrillators and is compatible […]
Siemens to acquire Corindus in $1.1B deal
Corindus Vascular Robotics (NYSE:CVRS) reported its second-quarter financials today, revealing that it inked a deal to be acquired by Siemens Healthineers (NYSE:SI) in an all-cash deal valued at roughly $1.1 billion. Siemens Medical Solution, a subsidiary of Siemens Healthineers, is slated to acquire all issued and outstanding common stock in Corindus for $4.28 apiece in cash. The […]
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