LONDON – Memed Diagnostics Ltd. has adapted the point-of-care test it developed to distinguish bacterial from viral infections to enable rapid assessment of the severity of COVID-19 infections in patients being admitted to the hospital. The triaging tool, Memed COVID-19 Severity, has received a CE mark in Europe and is ready for commercial rollout. After securing the CE mark, Memed is now pursuing emergency use authorization for the test from FDA.

Researchers from Finland and Italy published a biomarker-based algorithm for the diagnosis of dementia in the journal Diagnostics. The algorithm enables clinicians to distinguish between various neurodegenerative diseases with shared clinical presentations and select appropriate treatment. The algorithm relies primarily on blood biomarker measurements to diagnose the type of dementia much earlier than is possible with the diagnostic tools in use today.

Medtronic plc launched the newest product in its coronary portfolio, the Prevail drug-coated balloon (DCB) catheter, in Europe following CE mark approval. The device is intended for use during minimally invasive procedures to open narrowed or clogged arteries in patients with coronary artery disease.

PARIS – The French government reported setting up the “Artificial Intelligence and Cancer” association, a public-private partnership that brings together the French National Cancer Institute (INCA), the Health Data Hub and the Health Industry Alliance for Research and Innovation (ARIIS), along with eight commercial firms. The eight commercial firms, whose identities have not yet been released, are drawn from a large consortium of pharmaceutical and information technology firms and health care insurers, that has been around since 2019.

PARIS – Royal Philips NV is working with the Spanish National Center for Cardiovascular Research (CNIC) on an ultrafast cardiac magnetic resonance imaging (MRI) protocol that could reduce scanning times to just a few minutes.

LONDON – An attempt to develop an alternative sampling method to replace unpleasant nasopharyngeal swabbing in COVID-19 diagnosis has failed, with researchers at Owlstone Medical Ltd. finding the number of viral particles that can be collected from the breath of hospitalized patients is below the limit of detection. Owlstone is a specialist in collecting and analyzing breath samples to look for volatile organic compounds that are biomarkers of disease, such as lung cancer and asthma.

Vivasure Medical Ltd. has designed a sutureless and absorbable venous vessel closure for use following percutaneous cardiovascular procedures, such as transcatheter mitral valve or tricuspid valve repair or replacement. The Perqseal Blue technology builds on the Galway, Ireland-based company’s Perqseal, which received the CE mark for vascular closure of femoral arteries in 2016.

LONDON – The U.K. Medicines and Healthcare products Agency (MHRA) has embarked on wide-ranging reforms that are designed to make the most of post-Brexit regulatory flexibility while capitalizing on the ‘spirit of the pandemic,’ which has seen it rise to the occasion in supporting rapid set up of large-scale randomized clinical trials and approvals of COVID-19 vaccines.

The European Commission has posted the first sets of standards for the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The new publications had been long-awaited as more and more manufacturers leverage voluntary consensus standards to comply with requirements across regulatory bodies while promoting international harmonization.