Nervtex Co. Ltd.’s diagnostic assessment software Modas for movement disorders such as Parkinson’s disease has been given NMPA approval in China. Using smart mobile devices, Modas can process video data collected from people with potential or existing movement disorders when they are in any specific motion state.
Act Genomics (Hong Kong) Ltd. won U.S. FDA approval for its genomic profiling test for solid tumors, Actonco. This marks the first time an Asia-based company has received FDA clearance for a comprehensive genomic profiling test.
Nuralogix Corp. is taking its selfie-based health monitoring platform to the next level, offering continuous health and vital signs tracking during video calls. The launch of Anura Telehealth is the newest addition its Anura app, which uses video cameras on smartphones and other consumer devices to extract facial blood flow information and provide a personalized snapshot of health and wellness.
The U.S. FDA has approved Polarean Imaging plc’s drug-device combination product, Xenoview, for use with magnetic resonance imaging (MRI) in evaluating lung ventilation in adults and children aged 12 and older. The hyperpolarized contrast agent, which is prepared from the Xenon Xe 129 gas blend, is expected to be commercially available in the U.S. starting next month.
Numares Health AG received $21.2 million from the European Investment Bank (EIB) in support to its automated and software based IVD platform for obtaining high-quality nuclear magnetic resonance metabolomics data from blood or urine biopsy samples.
Seekin Inc.’s cancer mutation detection kit Pancanseek for leukemia patients has received a CE-IVD mark, expanding the company’s reach in the testing space.
A new acute coronary syndrome detection system developed by Neuome Peptides Pte. Ltd.’s aims to make tests for the frequently lethal condition faster, more precise and less invasive. Neuome’s Truheart is a point-of-care assay for cardiovascular disease that is used in the company’s established Instadetect assay development platform. The assay measures the biomarkers troponins I and T and myoglobin.
Earlysight SA is developing a novel ophthalmology device that can be used to diagnose certain degenerative eye disorders long before onset of first symptoms. Earlysight and researchers at the Swiss Federal Institute of Technology Lausanne (EPFL) have reported positive results for their first clinical trial of Cellularis in the journal Ophthalmology Science.
U.S. federal authorities have made a lot of noise over inappropriate medical testing in the past two years, largely due to the COVID-19 pandemic, but Paul Garcia, a partner in the San Diego office of Hooper, Lundy & Bookman PC, says this trend will not ebb at all in the coming year. Garcia told BioWorld that the lookback period for Medicare testing claims runs several years and that not only will enforcement results continue to surface next year, but also that the associated civil monetary penalties could force a testing lab to shutter its operations permanently.
Fujifilm Corp. inked an agreement to purchase the global digital pathology business of Inspirata Inc., paving the way for expansion of its Synapse enterprise imaging offering. The transaction includes Inspirata’s Dynamyx software, which Fujifilm has distributed in the U.K. and certain European Union countries since mid-2020. Under the agreement, Fujifilm will acquire Inspirata’s digital pathology technology, as well as employees and customers associated with the brand. Financial terms of the deal were not disclosed. It is expected to close in early 2023.
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