Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genesis Software, Oncores Medical, Paragon.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Autogen, Axim Biotechnologies, Cell Projects, Centogene, CN Bio, Eagle Genomics, Empowered Diagnostics, Exagen, Femselect, Fluxergy, Gene Group Holdings, Genostics, Heartflow, Isohelix, Konica Minolta, Lina Medical USA, Medaxiom, Nvoq, Oncimmune, Perahealth, Rxbio, Sientra, Spectrum Solutions, Stagezero, United Health Products, US Medical Innovations, Vtnc.
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.
Soulbrain Holdings Co. Ltd. ramped up its unusual diversification program with the acquisition of Pixcell Medical Technologies Ltd. as part of the semiconductor company's shift into health care and in vitro diagnostics. The acquisition of Pixcell follows Soulbrain’s acquisition of Ark Diagnostics Inc. in 2018 as the company looks to the bio-health care industry as its "engine for new growth."
The FDA’s May 4 webinar on patient data generated over the course of the product life cycle covered a number of topics, including the use of social media as a source of real-world evidence (RWE). The FDA’s Anne Hammer said, however, that while social media engagement has exploded over the past couple of decades, issues such as data duplication and verifiability will have to be resolved before patient engagement via social media can be relied upon as a source of RWE for regulatory purposes.
Acutus Medical Inc. appears to have solved one of the more vexing problems in cardiology, the sheer persistence of persistent atrial fibrillation despite treatment. In a study recently published in Heart Rhythm, the Carlsbad, Calif.-based company demonstrated that 73% of patients undergoing ablation using the new pulmonary vein isolation plus core-to-boundary guided approach experienced acute termination of AF after one procedure, compared to 10% of patients undergoing ablation with the traditional posterior wall isolation approach.
Using advanced intravital microscopy to visualize immune cell movement within the tissues, investigators at the Peter Doherty Institute for Infection and Immunity, Melbourne have discovered that the neurotransmitter noradrenaline produced by the sympathetic nervous system causes a dramatic paralysis of immune cell movement.