The shortage of European notified bodies (NBs) for in vitro diagnostics has prompted calls from industry to delay the compliance dates for the In Vitro Diagnostic Regulation (IVDR), and the European Commission has responded with a proposed fix. The Commission proposed to give IVDs that are already on the market until May 2025 or later to obtain new CE marks, but the change requires the assent of the European Parliament and the European Council before it goes into force.

The Scottish government has signed a deal with digital therapeutics company Big Health Inc. to make a cognitive behavior therapy (CBT) platform for anxiety and insomnia available through the NHS. It makes Scotland the first country to provide a digital therapeutic for anxiety and insomnia nationally.

Medtronic plc’s Hugo robotic-assisted surgery system has received a CE mark for urologic and gynecologic procedures, paving the way for commercialization in Europe. The approval is a key milestone for the Dublin-headquartered company, following the launch of Hugo in Latin America and India. The company is prioritizing robotics as a major growth opportunity, but will face tough competition in the space as it goes head-to-head with established market leader Intuitive Surgical Inc. According to Medtronic, Europe could provide a significant opportunity due to its current low uptake of surgical robotic procedures.

Mindmaze SA raised $125 million in a debt financing round led by Albacore Capital Group to expand its virtual reality-based digital neurotherapeutics platform. Total funding for Mindmaze now exceeds $235.7 million to date. Investors include the Hinduja Group, Venture Kick, the Foundation for Technological Innovation, and Leonardo DiCaprio. The Mindmaze platform assesses and restores cognitive and motor function in individuals who have sustained neural injuries or impairment from degeneration and aging.

Calpro AS and Ampersand Health Ltd. are combining technologies to provide a self-management and remote monitoring solution for people with inflammatory bowel disease (IBD). The partnership will integrate Oslo, Norway-based Calpro’s smart biomarker test with Ampersand’s digital therapeutic app My IBD Care. The companies said the collaboration could help reduce the administrative burden of IBD patient care.

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.