LONDON – Long-awaited guidance on how software will be treated under the stricter EU devices regulations brings clarity but also adds to the mountain of preparations needed to comply with the new rules. The vast majority of software products that are treated as class I under the current rules – and therefore self-certified – will be upgraded to class IIa and higher under the Medical Devices Regulation (MDR) coming into effect in May 2020, and the In Vitro Diagnostic Regulation (IVDR), which takes effect May 2022.
PARIS – A French research consortium bringing together the firm Cap Gemini SE, the Traumabase (traumabase.eu) network, the AP-HP group of 39 teaching hospitals in the Paris region, the École Polytechnique, the National Center for Scientific Research (CNRS) and the Ecole des Hautes Etudes en Sciences Sociales (EHESS), is developing the first AI decision-making tool for managing patients with severe trauma in their first 24 hours.
LONDON – The EU's next large-scale public-private research partnership in health is taking shape and due for launch at the start of 2021, succeeding the current €3.6 billion (US$4 billion) Innovative Medicines Initiative 2 (IMI2).
PARIS – Myriade SAS reported the commercial launch of its Videodrop technology at the second congress of the French Society of Extracellular Vesicles (FSEV) held in October in Nantes. This new nanoscale imaging technique captures all nanoparticles ranging from 30 nm to 10 μm in a droplet of solution (5-10μl volume), without initial data labeling.
LONDON – Pfizer Inc. is taking further steps to distinguish its third-generation anaplastic lymphoma kinase (ALK) inhibitor, Lorbrena, from the rest of the field, funding a pan-European trial that will use liquid biopsies to track the resistance profile of non-small-cell lung cancers (NSCLC).
LONDON – A U.K. national plan to upgrade population cancer screening will see greater adoption of genomics and biomarker-based testing, and the use of artificial intelligence to help interpret results. There will be moves to make it easier to pilot and adopt novel diagnostics and to do more targeted screening to identify and follow people who are shown to be at greater risk of developing specific types of cancer.
DUBLIN – Sofinnova Partners closed its ninth early stage venture capital fund, Sofinnova Capital IX, at €333 million (US$369 million) and is bringing the same playbook to bear on current investment opportunities that it has followed in the recent past.
As the U.K. pursues its divorce from the EU, smaller U.S. drug and device companies could be caught disproportionately in the collateral damage. Many of them already struggle with the cost of duplicative regulatory requirements involved in marketing their products in the EU, but those costs could increase under Brexit, according to a report released last week by the U.S. International Trade Commission on trade-related barriers impacting U.S. small- and medium-sized enterprises (SMEs) that export to the U.K.
PARIS – Carmat SA, from Vélizy Villacoublay, France, has just raised $66 million from European specialist investors in the life sciences and medical technologies sector.
The emerging methodology of federated learning can overcome many of the ethical and privacy obstacles preventing patient data from being pooled for analysis, according to research published this week.