Memed Diagnostics Ltd. has published new data from an EU Commission funded clinical trial evaluating its blood test for differentiating bacterial and viral infections. The prospective, multicenter cohort study, titled “AutoPilot-Dx,” was carried out in emergency wards in Italy and Germany. The goals of the study were to validate the performance of Memed’s BV test in a broad pediatric population with respiratory tract infections or fever without source and estimate its potential to impact antibiotic use.

PARIS – Diagnostic Medical Systems SA (DMS) is spinning off its medical imaging division into Asit Biotech NV. This agreement, between two firms listed on the Euronext exchange, involves French med-tech company DMS merging its flourishing medical imaging business with the Belgian biopharmaceutical firm and acquiring a controlling stake in the company.

The U.K. National Institute of Health and Care Excellence (NICE) issued two health technology assessments dated Nov. 24, including one that gives a guarded recommendation for devices used to narrow the coronary sinus as a treatment for refractory angina. Neovasc Inc., of Richmond, British Columbia, touted the news as a positive for its Reducer device, given that this is the first instance in which NICE has lent any support for a device to treat the condition.

PARIS – Pcube-Lab BV has closed a $4.75 million funding round to deploy its eye tracking technology, Neuroclues, in Europe and the U.S. This technique helps with early diagnosis of neurological disorders such as Parkinson's, multiple sclerosis and Alzheimer's disease.

The European Investment Bank (EIB) pumped €15 million (US$17 million) into Xeltis BV to accelerate clinical programs for its polymer-based technology platform for cardiovascular restoration. The Eindhoven, Netherlands-based company is developing three types of cardiovascular implants. These are a pulmonary heart valve, coronary artery bypass graft and hemodialysis access grafts. The devices use a therapeutic approach called endogenous tissue restoration (ETR), which causes the patient’s own body to naturally restore a new blood valve. As the patient’s healing system develops a functional valve, Xeltis’ implant is gradually absorbed by the body.

Fujirebio Europe NV launched two new cerebrospinal fluid (CSF)-based immunoassays for Alzheimer’s Disease (AD) on its Innotest platform. It’s the first product launch for the company following a collaboration agreement signed with Adx Neurosciences NV in September 2020. The assays will test for neuronal pentraxin-2 (NPTX2) and soluble triggering receptor expressed on myeloid cells 2 (STREM2). Both neurology biomarkers are linked to synaptic dysfunction and neuroinflammation which are considered core features of AD progression. Fujirebio said the new tests will support existing research for AD drug development.

LONDON – Medical research charities that form an integral part of the U.K. health research system are still reeling from the impact of COVID-19 and now expect it will be three years before funding returns to pre-pandemic levels.

Glyconics Ltd. landed £1.5 million (US$2 million) in an Enterprise Investment Scheme funding round to finance a clinical trial of its diabetes screening tool, Glyconics-SX. The Cambridge, U.K.-based diagnostics company is developing a point-of-care, hand-held device using miniaturized infrared (IR) spectrometry. The technology scans fingernails, assessing glycation to identify diabetes within minutes.

LONDON – The first commercial implantations of Istar Medical SA’s minimally invasive Miniject supraciliary glaucoma drainage device have taken place in Germany, following European CE approval for the product.

The European Union’s Medical Device Coordination Group (MDCG) continues to churn out guidances for the new Medical Device Regulations (MDRs), but there are several nagging questions about devices granted market access under the legacy system. MDCG has clarified that these devices will be subject to postmarket surveillance requirements under the MDR system rather than the previous system, although it is not a simple process to determine when this approach does and does not apply.