LONDON – Cumulus Neuroscience Ltd. has raised £6 million (US$8.3 million) to advance development of its home use wearable headset for tracking response to treatment in clinical trials in psychiatric disorders and neurodegenerative diseases, including Alzheimer’s.

LONDON – Neogenomics Inc. reported it plans to acquire Inivata Ltd., taking up a $390 million fixed price option to purchase the liquid biopsy specialist eight months early. The option was agreed to in May 2020, when Neogenomics made a $25 million minority equity investment in Inivata and was granted the right to acquire the rest of the company by the end of 2021.

The European Commission posted a draft legislative framework for regulation of artificial intelligence (AI), a document that spans all potential uses of such algorithms rather than just medical ones. The text seems to suggest that all medical uses of AI will be deemed high-risk uses, but this draft is just the opening salvo in a process that will span a year, perhaps longer, before the legislation will be drafted and finalized.

PARIS – Archos SA reported setting up a center of excellence in med-tech. They are working in close partnership with various SATTs – technology transfer acceleration offices, who finance innovative research lab projects in France. Their new division, Medical Devices Venture, is designed to help develop startups targeting the health care disciplines of the future that combine technology, machine learning and a platform for collaboration.

HONG KONG – Celltrion Inc. has received the European CE mark for Tekitrust, its COVID-19 tests kit developed with Mico Biomed Co. Ltd. “Mico, which is a diagnostic device specialist, partnered with Celltrion to combine both companies’ strengths in the test kit sector,” a Celltrion spokesperson told BioWorld. Mico will manufacture the kits, while Celltrion handles marketing and sales.

PARIS – Urgo Group SAS has just been awarded $27.7 million in financial support from the French government, to help develop artificial skin for treating deep skin wounds and massive burns.

PARIS – One month before the Medical Device Regulation (MDR) comes into force in the EU, the European Association of Notified Bodies (Team-NB) has released the results of its latest annual survey. This survey of CE-marked medical devices compiled data from 26 notified bodies who were members of Team-NB at the end of 2020. According to Team-NB’s 2020 survey, a total of 18,784 valid CE certificates had been issued by last year, representing an increase of 35% over 2010.

Onward NV secured $32 million in a new financing round led by Invest-NL and Olympic Investments. All the company’s existing investors also participated in the round, including medical technology investors LSP, Inkef Capital, Gimv, and Wellington Partners. The new funds will support Eindhoven, Netherlands-based Onward's development and commercialization of its Arc-Im and Arc-Ex spinal cord systems, designed to provide targeted spinal cord stimulation to help people with spinal cord injuries regain movement and independence.

PARIS – Imageens SAS just raised a $1.4 million seed round to develop its two artificial intelligence (AI) systems in the field of medical imaging in Europe. Its first solution Artfun+, an AI software application, makes it possible to anticipate cardiovascular pathology thanks to new prognostic biomarkers. Its second product is Label, an algorithm which automatically classifies and assesses medical imaging data.