Ibex Medical Analytics Ltd. extended the reach of its artificial intelligence (AI) powered pathology system, adding gastric cancer to existing CE mark approvals in prostate and breast cancer.
Stratipath AB gained CE-IVD mark for its artificial intelligence (AI)-based software for prognostic risk stratification of breast cancers, clearing the path for introduction of the solution in the EU. Stratipath Breast analyzes digital histopathology whole slide images generated from surgically resected breast cancer tissue to identify patients with increased risk of disease progression. The system provides clearer guidance on the best treatment path for the 50% of women whose breast cancer is categorized as intermediate risk.
Volitionrx Ltd. won the CE mark for its Nu.Q NETs test for the detection, evaluation and management of NETosis, a type of cell death characterized by the release of neutrophil extracellular traps, or NETs. The test – the first biomarker approved for the measurement of NETs for patient management – will soon be available for clinical use across the E.U.’s 27 member states.
Lumiradx Ltd. has secured CE marking for its HbA1c test for diabetes. The point-of-care (POC), automated fingerstick assay is run on the Lumiradx portable platform and designed to provide connected results in under seven minutes, with a reportable range of 20-130 mmol/mol HbA1c (4.0% to 14.0% HbA1c).
Organ transplant diagnostic company Caredx Inc. has received CE marking for its Alloseq HCT chimerism testing kit and Alloseq HCT interpretation software for use in patients who have received hematopoietic cell transplantation (HCT). The NGS-based solution is used to monitor engraftment and evaluate the success of a hematopoietic stem cell transplant by measuring the relative ratio of the recipient and the donor cell population post-transplantation.
Venus Medtech (Hangzhou) Inc.’s Venusp-Valve, a transcatheter pulmonic valve replacement (TPVR) system, has gained the CE mark in Europe. The system is used to treat moderate to severe pulmonary regurgitation with or without right ventricular outflow tract stenosis. The TPVR provides an alternative for those not eligible for open-chest operations because of the risks such as large trauma, and slow recovery, a spokesperson of Venus Medtech told BioWorld.
Norwegian diagnostics company Cardinor AS landed a CE mark for its Secretoneurin (SN) ELISA (enzyme-linked immunosorbent assay). The blood-based test detects SN, a small 33-amino acid neuropeptide produced by neuroendocrine and heart muscle cells. Studies have shown the biomarker is a predictor of mortality in major patient cohorts, including ventricular arrhythmia, acute heart failure, acute respiratory failure patients with cardiovascular disease (CVD) and severe sepsis.
The C-suite at Dexcom Inc. is breathing easy with the company having snagged CE marking for its latest continuous glucose monitoring (CGM) system, the G7, less than two weeks after receiving FDA breakthrough device designation for its CGM for hospital use. “This all-new platform offers an incredibly powerful CGM that is simple to use, providing our users with insightful glucose data on one screen that helps them spend less time managing diabetes and more time doing the things they love. Dexcom G7 takes everything people love about G6 and makes it even better,” said Dexcom CEO Kevin Sayer.
Sense Biodetection Ltd. is preparing to launch a new rapid, disposable, point-of-care molecular diagnostic test for COVID-19 in Europe after securing CE marking for the platform. The company will make its Veros COVID-19 test available in Ireland, Benelux and Nordic countries this quarter before expanding to other European markets.
PERTH, Australia – Australian digital health company Resapp Health Ltd. received clearance from Australia’s Therapeutics Good Administration and CE mark certification in the EU for its stand-alone cough counter application that tracks cough frequency using a smartphone. The class I software as a medical device is the first regulatory approval for such an application, which uses Resapp’s machine learning algorithms to identify cough events from audio recorded using the smartphone’s in-built microphone.
