PARIS – M.A. Med Alliance SA (Medalliance), along with its Japanese partner MDK Medical, has completed enrollment following acceptance of a clinical trial notification from the Japanese Pharmaceutical Products and Medical Device Agency (PMDA) in June 2020.

A cloud-based web application for long-term brain monitoring has received a CE mark to support personalized management of neuro-disorders such as epilepsy. Developed by Swiss neuroscience research organization Wyss Center, Epios Cloud displays and reviews electroencephalogram (EEG) recordings made by EEG devices using scalp and sub-scalp electrodes, heart rate and accelerometer measurements.

Medtronic plc strengthened its suite of products for minimally invasive spine surgery with several new additions. The portfolio provides an integrated solution that includes implants, navigation, robotics, and artificial intelligence to streamline transforaminal lumbar interbody fusion (TLIF), customize treatment for patients and improve outcomes.

LONDON – Industry-sponsored clinical research in the U.K. took a big hit in the pandemic and is still struggling to catch up – and to capitalize on innovative trial designs and delivery approaches that were so successful in speeding up COVID-19 studies.

The EU’s Medical Device Regulation is now in full implementation mode, but the In Vitro Diagnostic Regulation (IVDR) won’t kick in until May 2022. Oliver Bisazza, director general of Medtech Europe, said that only six notified bodies are currently certified to review IVDs under the new regulatory framework, a predicament which suggests that many these tests will never again be available to patients.

LONDON – Industry groups, patients’ representatives and clinicians have launched the European Alliance for Cardiovascular Health (EACH) to lobby for a comprehensive EU policy to address the increasing burden of cardiovascular disease.

Illumina Inc.’s troubled takeover of Grail Inc. is facing further backlash from the European Commission (EC) after the regulator issued a statement of objections to the companies following their alleged breach of the EU Merger Regulation. Illumina’s acquisition of Grail has faced scrutiny from regulators since it was first announced due to concerns the deal could curb innovation and competition.

The U.K. government has doubled down on its overarching strategy for artificial intelligence (AI) with a 10-year plan to sustain the nation’s place in the global AI race. One of the key considerations in this plan is to revisit the criteria for status as an inventor, a clear nod to the dilemma presented by proponents of allowing the DABUS algorithm to be named as an inventor.

The U.K. National Institute of Health and Care Excellence (NICE) has examined the evidence for the use of mitral valve-in-valve procedures and found the evidence for safety is well rounded despite concerns about several complications.

LONDON – A pan European research project is working with manufacturers and clinicians to set measurement standards that will transform magnetic resonance images from 2D and pictorial, to 3D and quantitative, significantly increasing their diagnostic power. The project, led by the U.K. metrology body, the National Physical Laboratory (NPL), aims to introduce consistency and specificity for diagnosing specific conditions, by setting independently verifiable ways of noninvasively measuring lesions and the composition of different tissues and organs.