PARIS – The new European regulation on medical devices came into force on May 26, 2021, one year later than planned, due to the COVID-19 pandemic. This European medical device regulation (MDR) modifies the conformity assessment procedure for medical devices in the 27 countries of the European Union, repealing two council directives implemented in the early 1990s.
PARIS – The team from the ENT surgery department at Clermont-Ferrand University Hospital recently placed a cochlear implant into a patient with profound deafness using the Collin Medical SAS otologic robot in a hybrid operating room known as Imabloc.
The U.K. National Institute for Health and Care Excellence (NICE) has recommended the use of the Kardiamobile as an option for detecting atrial fibrillation (AF) events in patients diagnosed with suspected paroxysmal AF. Alivecor Inc., of Mountain View, Calif., is the obvious beneficiary of the recommendation, a good bit of news given the company’s struggles to maintain patent protection for its products.
PARIS – A team of researchers from the Université Grenoble Alpes, France, has been working on X-ray phase-contrast imaging (PCI) for investigating osteoarthritis. The team at the Inserm Synchrotron Radiation for Biomedicine (Strobe) laboratory in Grenoble, France has spent the last five years working with Grenoble-based firm Novitom SAS on this new imaging modality for osteoarticular conditions.
PARIS – Milvue SAS completed a series A round, raising more than $9 million towards deployment of its artificial intelligence-based software solution used for diagnosis and full triage of osteoarticular pathologies in emergency departments.
PARIS – Two months after successfully listing on Euronext Brussels and Euronext Amsterdam stock exchanges, raising nearly $100 million, Onward Medical NV reported completion of enrollment in its Up-LIFT study on its noninvasive electrical spinal cord stimulation, called Arc therapy.
It is acknowledged that the huge bias toward individuals of European ancestry means studies of the contribution of genetics to disease may not translate well to other ethnicities. That point is underlined in the first large-scale investigation of the population structure and demographic history of British Pakistanis, which shows an increased number and length of regions of homozygosity inherited from a common ancestor, and greatly elevated identity by descent, compared to the population at large.
PARIS – Bellaseno GmbH reported publication of first-in-human data for its 3D-printed biodegradable and highly porous Senella scaffold filled with autologous fat graft to correct a chest deformation in a 22-year-old patient with severe pectus excavatum. The article was published in the European Journal of Plastic Surgery.
An international study led by scientists at the University of Exeter in the U.K. suggests how to combine antibiotic and bacteriophage therapy optimally, in order to reduce antibiotic use and potentially prevent multidrug resistance in bacteria.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has unveiled two guidances for the use of real-world evidence (RWE) in regulatory decision-making. The policy seems limited to pharmaceutical clinical trials, with no indication when it will be expanded to include medical technology.
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