LONDON – The U.K. is setting up a service for developers and users of artificial intelligence (AI) to provide a single source of advice covering all requirements for the technology, from clinical research to regulatory scrutiny, health technology evaluation and through to commissioning.

Avicenna.AI has enjoyed a head-spinning series of regulatory nods for its artificial intelligence (AI)-based solutions for serious vascular conditions including stroke, pulmonary embolism (PE) and aortic dissection. The Marseille, France-based company gained CE mark for its tool that quantifies the severity of a stroke based on a CT scan of the brain and displays regions that have suffered infarcts in late May, followed by CE mark and FDA 510(k) clearance for its product that permits emergency triage of PE and aortic dissection from CT-scan imaging in early June.

Paris – Cardinor AS has secured $1.44 million to commercialize development of a novel ELISA (enzyme-linked immunosorbent assay) blood test that uses secretoneurin as a blood-based biomarker for heart disease and sudden cardiac arrest. London-based Intuitive Investments Group plc participated in this third seed round, along with existing Belgium and German investors.

PARIS – Gleamer SAS said Radiology published compelling results from a study evaluating the performance of its artificial intelligence (AI) system Boneview, which helps radiologists and emergency doctors detect and localize fractures. This is the first study to evaluate the performance of AI-assisted health care professionals in locating bone fractures on all appendicular X-rays.

A new 3D printing technique has allowed University of Nottingham researchers to tailor-make artificial body parts and other medical devices that are both implantable and bacteria-resistant. The multi-materials manufactured in the study were also adapted to 3D printing technology that is able to offer devices that can better meet the need of the patient and minimize the surgeries led by device failure that increase the risk of infections.

LONDON – Controversy over the quality of the data supporting approval of Biogen Inc.’s Aduhelm (aducanumab), and FDA’s requirement for a phase IV study to demonstrate real-world evidence of the effectiveness of the drug, has put the spotlight on the need for better dementia diagnostics, both to stratify trials and to track any reduction in clinical decline.

PARIS – Affluent Medical SAS aims to raise $40 million on the Euronext Paris regulated market to finalize the development of three minimally invasive prostheses in urology and interventional cardiology. The Aix-en-Provence, France-based med-tech will issue 3,387,210 new shares. Affluent has already received subscription pledges exceeding $24 million, including $12 million from funds managed by Paris-based Truffle Capital.

Eyeyon Medical Ltd. has won CE mark approval for its flagship product, Endoart, a synthetic implant that replaces the human endothelium, which the body can’t regenerate. Designed to treat chronic corneal edema, it could help to reduce the long wait times for human donor corneas. Approval was based on a first-in-human trials involving 22 patients who received Endoart implants and were followed for 24 months.

Medtrace Pharma A/S raised $30 million in a series B round to ramp its platform for production, infusion and analysis of ¹⁵O-water in medical imaging. Swiss-based Swisscanto Invest, along with fund managers ATP and Bankinvest group from Denmark, are the lead investors. “We can now ramp our European and U.S. expansions plans in myocardial perfusion imaging and in other indications in need of perfusion data,” Martin Stenfeldt, CEO and co-founder of Medtrace, told BioWorld.

The European Commission (EC) unveiled on Monday its new joint implementation and preparedness plan for the European Union’s In Vitro Diagnostic Regulation (IVDR). It sets forth priority actions, noting “the implementation of the IVDR has proven to be a very challenging task,” exacerbated in the response to the COVID-19 pandemic “despite the efforts undertaken by all” to transition.