Biosense Webster Inc. scored approval from Japan’s Ministry of Health Labour and Welfare’s (MHLW) for its Varipulse pulsed field ablation platform to treat symptomatic drug-refractory recurrent paroxysmal atrial fibrillation on Jan. 9., making it the first PFA system approved in the country.
Listening to conversations between a mother and her unborn child on the cellular level could inform how the pregnancy is going and prevent complications. Three scientific groups from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), in collaboration with Wayne State University and Michigan State University, have used single-cell RNA sequencing techniques to decipher these words, identify the cellular language of these interactions in the placenta and establish a cellular atlas.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neurolief, Pulsenmore, Providence Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3M Co., 3Spine, Abbvie, Akoya, Astek Diagnostics, Bone Biologics, Boston Orthotics, Caris, Chromacode, Concertai, Danaher, Dnanexus, Embecta, Endeavor Health, Genomicmd, Mediwound, Microsoft, Nevro, Orthopediatrics, Stryker, Thermo Fisher, Ultromics, United We Care.
Lumitex Inc. seeks patent protection for a phototherapeutic apparatus for treating inflammatory conditions, with a particular focus on treating acute respiratory distress syndrome.
Industry may still be less than fond of the failure of the term “recall” to distinguish between corrections and market withdrawals, but the class I recall of the Insulet Omnipod 5 app for Android smartphones is a correction of some importance. This recall, one of the first to be announced by the FDA in 2024, addresses a software problem that could lead to overdose of insulin, a potentially lethal problem for which the company has already provided a fix.
Researchers from the University of Auckland have developed a smartphone app called Mindear that reduced the impact of tinnitus in two-thirds of users over eight weeks.Tinnitus, often referred to as ringing in the ears, is the perception of sound without an external source and affects 10% to 15% of the global adult population. Previous studies to treat tinnitus have focused on neuromodulation devices, but a smartphone app could make treatment more accessible to a wider population.