Ultromics Ltd. joined forces with Pfizer Inc. to expedite U.S. FDA clearance of its artificial intelligence (AI)-enhanced platform to aid early diagnosis of cardiac amyloidosis, also known as stiff heart syndrome. The company received FDA breakthrough device designation last year for Echogo Amyloidosis, which uses deep AI to analyze echocardiograms and detect the presence of cardiac amyloidosis, a serious condition often missed during standard heart assessments.
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.