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.
PARIS – Arkhn SAS has finalized a $5 million seed round to help drive health care institutions towards secure and efficient data management. This financing round has been led jointly by the two French venture capital firms, Kurma Partners SA and Newfund SA, though their respective funds Kurma Diagnostics II and Newfund II.
LONDON – The U.K. health technology assessment agency, NICE, has called for a halt to the use of transvaginal laser therapy in the treatment of urinary stress incontinence and vaginal atrophy, saying there is not enough evidence of long-term safety, or proof that the procedures are effective.
Dsruptive Subdermals AB has completed a clinical showing body temperatures tracked by its chip implants are comparable to temperature readings from standard clinical thermometers. The Stockholm-based startup is now offering its injectable implants as an open platform for researchers seeking efficient, low-cost tools to monitor changes in body temperature.
Data on the prevalence of diabetes in the U.S. show that non-Hispanic white people are least likely to suffer from the disease. Yet to date most genetic studies of the glycemic traits that are used to diagnose and monitor type 2 diabetes and cardiometabolic health have focused on individuals of European ancestry.