PARIS – Diabnext SAS, of Versailles, France, has launched Clipsulin 3XS, a sensor intended to monitor and manage diabetes that the company says is compatible with all insulin pens on the market. “This is the first sensor that automatically reports insulin doses injected by the pen, in both children and adults,” Laurent Nicolas, co-founder and CEO of Diabnext, told BioWorld MedTech.
HONG KONG – Pentax Medical Co., of Tokyo, has gained CE marking for its artificial intelligence-based polyp detector Discovery. The detector assists endoscopists in finding potential polyps during a colorectal examination. The software has been trained using more than 120,000 files from about 300 clinical cases.
LONDON – While large-scale biobanks that link genomics to longitudinal health records of diagnosis, treatment and outcomes promise to revolutionize the understanding of the genetics of complex disease, the detailed statistical analysis of those high-dimensional data is still very much in its infancy.
LONDON – While large-scale biobanks that link genomics to longitudinal health records of diagnosis, treatment and outcomes promise to revolutionize understanding of the genetics of complex disease, the detailed statistical analysis of those high-dimensional data is still very much in its infancy.
PARIS – Biolog-id SAS, specialists in traceability and management of delicate health care products (red blood cells, plasma, platelets and chemotherapy substances), has just raised $33 million from fund managers Xerys Gestion. “Thanks to this new funding, we will be able to roll out our smart traceability solutions worldwide. These are used for managing labile blood products and plasma fractionation,” Jean-Claude Mongrenier, founder and CEO of the Boulogne-Billancourt, France-based company, told BioWorld MedTech.
The European Parliament this week formally agreed to delay the requirement for certain currently approved class 1 medical devices to comply with the new Medical Device Regulation (MDR) when it comes into force on May 26, 2020. Consequently, manufacturers of reusable surgical instruments and devices that have a measuring function will have an additional four years to meet the stricter requirements of MDR.
DUBLIN – Truffle Capital closed off its fifth Biomedtech fund with a €250 million (US$279 million) raise, which it will deploy in about a dozen companies located mainly in France. The fund took a little longer to close than originally planned but it is significantly larger than it had originally intended. “Our initial objective was €200 million,” Truffle Capital CEO and co-founder Philippe Pouletty told BioWorld.
PARIS – A team of medical researchers and engineers from the Gustave Roussy Institute, in Villejuif, France, and Paris-Sud University recently developed an artificial intelligence system called Resolved2, designed to assess prospective cancer drugs. As Loïc Verlingue, lead cancer specialist on the data science team at the Gustave Roussy Institute, explained to BioWorld MedTech, “this AI is intended to predict efficiently whether a cancer treatment molecule will achieve authorization or not within six years of pharmacological data and phase I clinical trials.”
DUBLIN – The European Medicines Agency’s Committee for Medicinal Products for Human Use closed out its year’s work with positive opinions on two applications, Novartis AG’s Beovu (brolucizumab) in wet age-related macular degeneration and Merck & Co. Inc.’s Recarbrio for treating gram negative infections in adults.
LONDON – Over the next decade pharmacovigilance will move on from a sole focus on adverse drug reactions (ADRs) to encompass monitoring of the in-market efficacy of medicines, according to Guido Rasi, executive director of EMA.
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