Regulatory agencies are starting to catch up on their guidance agendas, including the European Union’s Medical Device Coordination Group (MDCG), which has posted a guidance for risk classification. Rather than provide a list of risk classes for specific device types, the guidance provides a framework by which the manufacturer does its own evaluation of the inherent risk of the device, opening the door to disagreements between the manufacturer and its notified body.

PARIS – A Russian research consortium has discovered that coating magnetic nanoparticles with a non-magnetic silica shell significantly decreased the viability of cancer cells in a low frequency alternating magnetic field. This discovery may augur new therapeutic prospects for nanotechnology combined with medical imaging.

It may be a small country, but Lithuania has lofty ambitions. The Baltic country is emerging as one of Europe’s rising life science stars, with annual growth of 22% and targeting 5% of its GDP to be generated by the life sciences sector in 2030. Export of medical devices has also doubled since 2008, with majority of the country’s production reaching the U.K., France, Russia, Spain and the U.S.

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.